July 2011 digital edition of Anesthesiology News

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Please visit us at the American Association of Nurse Anesthetists booth #1414

The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • J u l y 2 0 1 1 • Volume 37 Number 7

Findings Support Less Cautious Stance On Catheter Removal Las Vegas—A multicenter study of more than 4,000 patients has confirmed what many clinicians have suspected and several smaller studies have suggested: Epidural catheters can be removed safely despite INRs higher than 1.4 during the initiation of warfarin therapy.

Patients in the investigation had INRs—international normalized ratios—ranging from 1.5 to 7.1.

“As most anesthesiologists know, the current ASRA [American Society of Regional Anesthesia and Pain Medicine] guidelines state that epidural catheters shouldn’t be removed if the INR level is above

Commonsense Pledge Cuts In-hospital Falls ‘Contract’ with patients produces significant results Las Vegas—Falls among hospitalized patients remain the most commonly reported adverse events in that setting. A simple fall-prevention strategy, however, may incur significant savings for the health care system. Researchers at the Connecticut Joint Replacement Institute at Saint Francis Hospital and Medical Center, in Hartford, were able to show that over a one-year period the risk for falling in patients admitted for total joint arthroplasty dropped by 60% using the intervention. The study was presented at the 2011 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 24); the abstract was honored as one of the best at the meeting.

see INR page 20

see falls page 12

Epidural Placement Enhanced With Simple Equation, Ultrasound

INside

Combined technique for catheter insertion used by trainees in morbidly obese parturients

18 | CLinical Anesthesiology

A

simple equation that uses a patient’s height and weight to estimate the distance from the skin to the epidural space appears to work when applied to some of the most challenging patients, the morbidly obese. The study was presented at the 2011 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract 30).

Trainees used a combination of the technique plus ultrasound

06 | IN Brief Music hath charms ...

a chart similar to that used to estimate body mass index (BMI); trainees simply plug in the height and weight of the patient, and the chart predicts the approximate distance from the skin to the epidural space.

“The equation works pretty well to estimate the epidural space in for our population,” said study 56 morbidly obese women, and author Manuel C. Vallejo, MD, achieved good accuracy (Pear- professor and director of obstetson correlation coefficient [CC], ric anesthesia at Magee-Womens see equation page 19 >0.85). The equation comes with

Protein shake during labor safely improves patient comfort.

26 | policy & Management Fair market valuation: the death spiral of physician compensation.

40 | Pain Medicine Outcomes monitoring for pain care coming soon to a clinic near yours.

46 | COMMENTARY Here’s looking at you, kid: medicine and the allseeing eye.

Educationalreview

Opioid Adjuvants for Multimodal Pain Management, see insert at page 24.

Newproducts Follow us on

Stimuplex® Ultra from B. Braun, see pages 10 and 27.

Ultipor™ Multiple-Patient-Use Anesthesia Breathing Circuits from Pall Medical, see pages 16 and 40.

@ anesthesianews

W What key element of an anesthesia service will you have to report differently when the “5010” yo electronic claims transactions standard replaces el th the current “4010A1” on January 1, 2012?

Find the answer at: www.anesthesiallc.com/an-jul11

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Heard Here First: If you are selling an anesthesia machine, never assume that what you have is unsaleable. ... There is a buyer for

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See article on page 32.

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July 2011

The five most-viewed articles last month on AnesthesiologyNews.com 1. Anesthesia Billing Cases Allege Rampant Fraud 2. Blood Transfusion Speeds Recurrence of Ovarian Cancer 3. More Evidence One Size of Anesthesia Doesn’t Fit All 4. Multimodal Management of Acute Pain: The Role of IV NSAIDs (Special Report) 5. Current Concepts in the Management of The Difficult Airway (Educational Review)

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he article “Physician Drug Monitoring With a Twist: Funded By Pharma” (June 2011, page 13), provided outdated information about Florida’s new prescription drug monitoring program. After the issue went to press, Gov. Richard Scott signed a law that, among other things, barred drug companies from providing financial support for the monitoring program.

In addition, the program has received more than $1.2 million in funding, not $500,000 (a figure obtained from

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its Web site, which has not been updated to reflect the correct amount).

The article also may have given readers the misimpression that the law affects both prescribers and dispensers. It only addresses physicians and pharmacists who dispense controlled substances. Finally, the article incorrectly stated that the reporter had made “requests” for comment to Purdue Pharma; only one such request was made. Anesthesiology News regrets the errors.

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IN B R I EF

Diversions in OR, ICU Can Reduce Sedation Needs Studies find benefits from music, movies

M

usic hath charms to … reduce sedation requirements? So says a new study which found that patients on mechanical ventilation required lower doses of sedatives when they listened to classical music.

Researchers at San Francisco General Hospital conducted the pilot study in five patients being ventilated in the intensive care unit after general surgery or trauma. All of the patients could hear, and none had evidence of mental illness, brain injury or hemodynamic instability.

The researchers recorded the patients’ vital signs, as well as how much sedation—in this case, dexmedetomidine (Precedex, Hospira)—and analgesia they received for an hour.

Then they fitted the patients with headphones through which they piped classical music from an iPod player for two hours. During that time, the researchers gradually reduced the dose of dexmedetomidine to the patients.

By the end of the two-hour period, the patients required an average of 33% less dexmedetomidine than they had before the music exposure, according to researchers. At the same time, their vital signs, pain and agitation remained steady.

The effect of the music treatment persisted for at least an hour after the experiment ended.

Anesthesiologist Julin Tang, MD, MS, who led the research, said he and fellow Dante Yeh, MD, have added five patients to the ongoing study. “I really don’t know what [the effect] is going to turn out to be, but I believe music is going to have some reduction” on the amount of sedation patients require, he said.

The choice of music might matter depending on the patient population. The investigators consulted with the faculty at the San Francisco Conservatory for suitable pieces. The playlist included piano works by Chopin, Mozart and Beethoven, as well as pieces by Haydn, Schumann and Bach—and for good measure, a quartet from the Russian physician-composer Alexander Bordin.

“The noise level seems to be more comfortable for human ears to listen to,” Dr. Tang said, although he acknowledged that “a 20-year-old kid might want heavy metal.”

The findings, which Dr. Tang

presented at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 903), ought not to be surprising. Soothing music in the operating room has been shown to reduce anxiety in patients undergoing surgery while receiving regional anesthesia (Anesth Analg 2004;98:1260-1266).

But pictures might be worth a thousand notes. New research presented at the 2011 annual meeting of the International Anesthesia Research Society (abstract S-134) found that patients who watched a movie during surgery, with nerve blocks, required markedly less propofol than did those

who listened to music or had neither diversion.

Anesthesiologists at the University of California, Irvine, studied 17 surgery patients who were randomly assigned to three groups: Some listened to music of their own choosing during the procedure; some watched movies, again

I NDI CATI ONS ULTIVA is indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting • As an analgesic component of monitored anesthesia care in adult patients

Vital signs and oxygenation must be continually monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, tachycardia, bradycardia, hypotension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continual monitoring is necessary.

ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

I M PORTA NT RI S K I NF ORMATI ON Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated.

ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response.

Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min.

Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs.

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AnesthesiologyNews.com I 7

IN BR IEF

“A Clockwork Orange” it’s not.

of their own choosing, through goggles; and some did neither.

All patients were allowed to self-administer propofol during the procedure with a personal pump. Patients who watched a movie consumed an average of 1.5 mcg/kg per minute, compared with 9 mcg/kg per minute by those who

listened to music. Patients reducing patient anxiwho used neither diversion ety,” the researchers wrote. fell in the middle, consum“This can be attributed to ing an average of 4.7 mcg/ [a] higher level of attenkg per minute. The diftion distraction during the ferences between groups surgery.” were statistically significant Although patients who (P=0.013), the researchers listened to music used said, and did not depend on Julin Tang, MD, MS more propofol than other the patients’ level of anxiety patients in the study, the prior to surgery. investigators said this result likely “This study shows that watch- reflected the small size of the groups. ing a movie has a beneficial effect in —Adam Marcus

The attributes of ULTIVA may offer more versatility than you realize.

Anesthesia providers are discovering all the benefits Remi provides to specific procedures and patient types.

You may find that the following benefits of ULTIVA shed light on a lot more of your anesthesia practice:

ULTRA-SHORT ACTING 1,2 RAPID RESPONSE 1 PRECISE CONTROL 2 FAST RECOVERY 3,4 ESTABLISHED HEMODYNAMI CS 3 NO ACCUMULATION 1 ORGAN-INDEPENDENT META BOLISM 1

PLEASE SEE IMPORTANT RISK INFORMATION BELOW

ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Please see the Brief Summary of the full Prescribing Information for all precautions, warnings, contraindications, and adverse events on the next page. *Remifentanil is commonly referred to as Remi by anesthesia providers.

ULTIVA is a registered trademark of Glaxo Group Limited.

Mylan Institutional is a registered trademark of Mylan Inc. References: 1. ULTIVA [package insert]. Lake Forest, IL: Bioniche Pharma USA LLC; 2009. 2. Egan TD. Remifentanil pharmacokinetics and pharmacodynamics: a preliminary appraisal. Clin Pharmacokinet.

1995;29(2):80-94. 3. Twersky RS, Jamerson B, Warner DS, Fleisher LA, Hogue S. Hemodynamics and emergence profile of remifentanil versus fentanyl prospectively compared in a large population of surgical patients. J Clin Anesth. 2001;13(6):407-416. 4. Fleisher LA, Hogue S, Colopy M, et al. Does functional ability in the postoperative period differ between remifentanil- and fentanyl-based anesthesia? J Clin Anesth.

2001;13(6):401-406.

RELOOK AT REMI. For more information, visit www.ultiva.com.

©2011 Mylan Institutional

JA016

May 2011

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IN B R I EF

Fears of Propofol Scheduling Overblown

W

hen administrators at the University of Colorado in Aurora added propofol to the institution’s catalog of Schedule II controlled drugs, the decision created a perfect opportunity for a case study on the effects the move would have on the practice of the institution’s 80-odd anesthesia providers.

The new policy, which went into

ULTIVA® for Injection

effect in December 2009, came in response to mounting concerns about the abuse potential of propofol, and anticipated by one year a proposal by the Drug Enforcement Administration to make the sedative a Schedule IV substance. But although many clinicians fear that such an official designation would prove burdensome, the Colorado experience suggests those

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information.

CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics.

Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/ kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the longterm (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil.

Remifentanil did not induce gene mutation in prokaryotic cells in vitro and was not genotoxic in an in vivo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitro mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant

concerns are largely unfounded.

“We were trying to look specifically at whether the scheduling changed how people practiced, and it really didn’t,” said Christopher Lace, MD, associate professor of anesthesiology at the University of Colorado and leader of the study.

Dr. Lace and his colleagues used their facility’s anesthesia information

women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

Postoperative Analgesia

After Discontinuation

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

ULTIVA (n=281)

Morphine (n=98)

ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent.

In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused.

OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a specific antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity.

ULTIVA is a registered trademark of Glaxo Group Limited.

US Patent Nos. 5,019,583; and 5,866,591 Version B, 06/08/2011 Manufactured for Bioniche Pharma USA LLC, Lake Forest, IL 60045 Manufactured by Hospira, Inc. Lake Forest IL 60045

management system (Centricity, GE Medical) to compare a variety of prescrib- Christopher Lace, MD ing patterns and patient outcomes in the six months before and after the scheduling. They looked at mean dose on induction, total dose per case, the incidence of hypotension within 15 minutes of induction and other variables in roughly 13,000 patients. Cases involving total IV anesthesia were not included in the analysis.

Before the scheduling, the mean induction dose of propofol was 121 mg (1.93 mg/kg); after, it was 124 mg (1.89 mg/kg), a statistically insignificant difference. The rate of hypotension— defined as a drop in systolic blood pressure of more than 20%—after induction was 14.5% before the switch and 16.5% after, again a statistically insignificant difference. Similarly, the proportion of patients receiving phenylephrine or ephedrine to counteract low blood pressure was roughly equal pre- and postscheduling, at about 45%.

Where Dr. Lace’s group did observe a difference, however, was in the number of cases in which clinicians administered exactly 200 mg of propofol—the full amount the hospital’s pharmacy dispenses for a single unit of the drug.

Before the scheduling, 92 of 6,146 patients analyzed (1.4%) received exactly 200 mg of the sedative; after the change, 220 of 7,359 patients (3%) received that amount.

Dr. Lace said the doubling in the number of cases in which precisely 200mg doses were recorded likely reflects efforts by anesthesia providers to comply with the requirement under the scheduling rule that they account for any wastage of controlled drugs. “If you have an extra cc or two in the syringe, now you have to account for it,” he said.

Rather than deal with that hassle, Dr. Lace said, clinicians simply administer the entire contents, either through the course of the case or at the end.

However, he stressed, that practice doesn’t seem to be harming patients.

The researchers note one potentially important caveat for the findings: They conducted their study against the backdrop of the ongoing propofol shortage, which began in earnest in the summer of 2009. Whether the results would be the same in a time of more ready supplies of the drug is unclear.

—Adam Marcus

J u ly 2 0 1 1

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C LIN I C A L A N ESTHES IOLOGY

Poor Adherence to Ventilation Rate Guidelines During Pediatric CPR

C

linicians often fail to properly perform cardiopulmonary resuscitation in children, generating excessive rescue breaths that could lead to potentially harmful “overventilation,” a new study has found.

Excessive ventilation during CPR can lead to reduced blood flow to the heart, and thus decrease survival rates, experts said. But the researchers observed overly vigorous resuscitation in nearly twothirds of CPR segments.

“Other studies have shown that hyperventilation can worsen outcome in animal models of global hypoxic-ischemic encephalopathy. Based on this data, researchers expect to see the same outcome in human brains,” said James Hutchison, MD, lead physician in the Brain Resuscitation After Ischemia and Neurotrauma Research Program at the Hospital for Sick Children, in Toronto, Canada. Dr. Hutchison, who was not involved in the new research, called the study “excellent.”

The latest study is the first to assess adherence to ventilation rate guidelines from the American Heart Association (AHA) for pediatric patients, said Advertisement

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Andrew McInnes, MD, pediatric anesthesiologist at The Children’s Hospital of Philadelphia, and leader of the group. The recommendations call for no more than eight to 10 rescue breaths per minute when performing CPR on children in cardiac arrest in the hospital.

Dr. McInnes and his colleagues conducted a prospective observational study to evaluate the frequency of ventilations delivered during in-hospital cardiac arrest in pediatric patients.

Ventilation frequency was measured using defibrillator pads that monitor changes in chest wall impedance (CWI), said Dr. McInnes, who presented the findings at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 448). Cardiac arrest events requiring CPR in patients aged 8 years and older in the pediatric intensive care unit or the emergency department were included.

Resuscitation events were divided into 30-second intervals, and the ventilation frequency during each interval was determined. As specified by the AHA guidelines, “excessive ventilation” was defined as a ventilation rate of more than 10 breaths per minute.

The researchers screened 26 patients, but only 24 of them had interpretable CWI waveforms, resulting in 588 30-second CPR periods, Dr. McInnes explained.

“We were surprised, and a bit disappointed, to observe that 63% of CPR segments showed rescue breath rates that exceeded the AHA recommendations [P<0.01]. This was significantly higher than our a priori hypothesis,” he said. In fact, more than 20% of the CPR segments showed a ventilation frequency at least double that recommended by the AHA, Dr. McInnes noted.

“This study provides only a very conservative estimate of overventilation, which is likely to be even a bigger problem than what we’ve been able to show here,” he added.

Again, the researchers could only speculate about the reasons behind the variability. One explanation could be that there is more supervision, staffing and training during the day and on weekdays, Dr. McInnes said.

Many processes of care are slightly altered at night and on weekends, Dr. Hutchison confirmed. It would be helpful to further research these processes to obtain a better understanding of resuscitation intervention compliance and reporting, he said.

Although excessive ventilation is a problem for many health care institutions, Dr. McInnes said, the small size of this study precluded his team from drawing any definitive conclusions about the relationship between overventilation and patient survival.

Another limitation of the study is the difficulty in capturing accurate ventilation data during CPR. “Capturing ventilation data via changes in chest wall impedance is good but not perfect,” Dr. McInnes said. “In the future, we hope to use additional measures, such as end-tidal carbon dioxide and/or airway pressure, to validate ventilation Working Too Hard on the Weekend? frequency.”

Why clinicians are so prone to overventilatTo improve ventilation rate adherence, frontline ing pediatric patients is unclear, Dr. McInnes health care providers need better tools to monitor said. Because most causes of cardiac arrest in children and provide feedback during resuscitation, as well as involve respiratory disease, one explanation could more frequent and effective training, Dr. McInnes be that providers focus on delivering excessive respi- said. Physiologic, patient-specific feedback also ratory support, potentially at the expense of CPR would be helpful, he said. hemodynamics, he suggested.

“We are in the process of developing a debriefing Still, Dr. McInnes said those results were not program to aid our care teams in continuously refinentirely unexpected. “However, the most intriguing ing and improving the quality of CPR,” Dr. McInnes finding was that CPR events on nights and week- said. Dr. Hutchison said his institution also is studyends were 3.6 times more likely to incur ventilation ing the quality of CPR and team function, as well as rates that exceeded AHA guidelines compared with educating providers about resuscitation guidelines in CPR events that occurred during the daytime and on general. weekdays [95% confidence interval, 1.6-7.9; P<0.01],” he said.

—Michelle Grey Campion

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AnesthesiologyNews.com I 11

CL IN ICA L A N ESTHESIO L OGY

Current Criteria May Underestimate Post-op Acute Kidney Injury

T

he most widely used definition of postoperative kidney injury misses more than 90% of cases, and needs revising, results of a new study suggest.

The National Surgical Quality Improvement Program (NSQIP) of the American College of Surgeons defines AKI as a postoperative change of greater than 2 mg/dL compared with baseline. But the investigators in the new study argue that the threshold should be redefined as a drop to as low as 50% of preoperative levels. That definition is known as the Acute Dialysis Quality Initiative’s Risk, Injury, Failure, Loss and End-stage Kidney (RIFLE) classification.

At least one expert not involved in the study agreed that the definition should better reflect changing patient demographics. “We are operating on older patients who often have multiple comorbidities and who can’t necessarily handle the stress of surgery as well as our younger patients, who may be more resilient to changes in serum creatinine,” said Peter Papadakos, MD, professor of anesthesiology, surgery and neurosurgery at the University of Rochester Medical Center, in Rochester, N.Y. Suspecting that NSQIP’s definition of AKI failed to detect many postoperative cases of the condition prompted Azra Bihorac, MD, assistant professor of critical care medicine at the University of Florida College of Medicine, in Gainesville, and colleagues analyzed data from 27,841 adults who had undergone surgery at Shands Hospital between 2000 and 2008. The subjects had an estimated glomerular filtration rate above 65 mL per minute per 1.73 m2 on admission.

The investigators found that 701 patients (2.5%) met the NSQIP’s criterion for AKI, compared with 10,228 patients (37%) who met RIFLE. Although RIFLE captured a group of AKI patients with milder disease, the relative risk for mortality was not lower when using the broader definition.

Patients with RIFLE-classified AKI were between three and six times more likely to die as those without AKI defined this way; patients with AKI defined by NSQIP were five to six times more likely to die as those without similarly defined AKI. Dr. Bihorac said many physicians delay diagnosing postoperative AKI until they observe large, absolute

changes in serum creatinine or a patient requires hemodialysis. Appreciating that small changes from preoperative levels can lead to complications and death can affect the use of potentially nephrotoxic agents, such as contrast, and ultimately may help prevent further deterioration of kidney function, Dr. Bihorac said.

“We need to raise awareness of the

potential impacts of small postoperative changes in serum creatinine,” she said. “Higher thresholds identify only 1% to 2% of surgical patients as having AKI, which we know is wrong. The actual prevalence of postoperative AKI lies somewhere between 20% and 40%.”

RIFLE was introduced in 2004 and has been gaining acceptance slowly.

Lynda Szczech, MD, president of the

National Kidney Foundation, said RIFLE is appearing increasingly in the research literature and that this “is the necessary first step toward clinical implementation.”

The researchers reported their findings at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 14).

—David Wild

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12 I AnesthesiologyNews.com

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Female/male, % 59/41

59/41

NS

30.9​±​ 7.5

33.7​±​ 12.0

NS

THA

38.8

39.3

NS

TKA

59.5

58.5

TSA

1.7

2.2

BMI, mean±SD Surgery, %:

BMI, body mass index (kg/m2); NS, not significant; SD, standard deviation; THA, total hip arthroplasty; TKA, total knee arthroplasty; TSA, total shoulder arthroplasty

Table 2. Characteristics of Patients Who Fell

Number of falls (%)

31 (1.4)

13 (0.6)

0.006

Age in years, mean±SD

68.7​±​ 10.2

65.5​±​ 9.4

0.340

Female/male, %

61/39

85/15

0.130

BMI, mean±​SD

30.9​±​ 7.5

33.7​±​ 12

0.370

THA

19.4

7.7

TKA

80.6

84.6

TSA

0.0

7.7

Femoral nerve catheter, %

58.1

38.5

0.234

Bathroom related, %

67.9

69.2

0.930

Assisted falls, %

10

15.4

0.613

Significance

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NS

Intervention Group (July 1, 2009 to June 30, 2010)

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Intervention Group (July 1, 2009 to June 30, 2010)

Patients were presented with basic edu- Table 1. Group Characteristics cational material about fall prevention and asked to sign a legally nonbinding pledge to call for assistance every time they got out of a bed or chair or made a trip to the bathroom. The nursing staff also pledged to be available in a timely manner.

“The important thing is that this 2,168 2,196 ‘contract’ is renewed every nurs- Number of patients ing shift,” Dr. Sinha said. “So, when there’s a change in nursing staff the Age in years, 66.3​±​ 66.0​±​ new nurses go to the room, introduce mean±SD 11.1 11.1 Control Group (July 1, 2008 to June 30, 2009)

“Our hospital has an inpatient unit dedicated to joint arthroplasty patients, where we found a fall rate that we considered unacceptably high,” said Sanjay K. Sinha, MD, senior attending anesthesiologist at Saint Francis and assistant clinical professor of anesthesiology at the University of Connecticut School of Medicine, in Farmington.

“We examined the data more closely and found that all our fall-prevention

education material really didn’t seem to be getting us anywhere, and that we could not predict which patients would fall [based on] the Hendrich II risk-assessment tool.” That analysis also revealed that most falls happened when patients ventured to the bathroom unassisted.

Dr. Sinha and his colleagues developed the “Call, Don’t Fall” strategy, the foundation of which assumed that every patient admitted for total joint arthroplasty was at high risk for falling.

Control Group (July 1, 2008 to June 30, 2009)

Falls continued from page 1

Significance

C LIN I C A L A N ESTHES IOLOGY

Surgery, %:

BMI, body mass index (kg/m2); SD, standard deviation; THA, total hip arthroplasty; TKA, total knee arthroplasty; TSA, total shoulder arthroplasty

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AnesthesiologyNews.com I 13

CL IN ICA L A N ESTHESIO L OGY ‘We examined the data more closely and found that all our fallprevention education material really didn’t seem to be getting us anywhere.’

—Sanjay K. Sinha, MD

themselves and remind the patients about the pledge. Then each of them re-signs it.”

All patients undergoing total joint arthroplasty at the institution between July 1, 2009 and June 30, 2010, participated in the new program. Patients who fell were assessed for injury, mental status and type of analgesic therapy.

The control group comprised patients admitted to the same unit during the previous year. The groups were demographically similar (Table 1).

The investigators found that the fall rate dropped from 1.4% (31 of 2,168) to 0.6% (13 of 2,196; relative risk, 0.4; P=0.006; Table 2). Two patients in the “Call, Don’t Fall” group sustained injuries, compared with one control. A greater percentage of patients who fell in both groups were women, although this did not reach statistical significance. The researchers also found that the overwhelming majority of patients who fell had been admitted for total knee arthroplasty (TKA; odds ratio, 7.4; 95% confidence interval, 1.0-15.4).

The study also revealed that 58.1% of TKA controls who fell had femoral nerve catheters in place at the time of the fall, compared with 38.5% of TKA patients in the intervention group (P=0.234). In each group, the majority of falls were bathroom-related (control group, 67.9%; intervention group, 69.2%). Falls were assisted in 15.4% of patients in the intervention group.

Dr. Sinha said nurses were encouraged by the program’s success. “They love it,” he told Anesthesiology News.

“When there’s a shift change, the nurses go in and introduce themselves to the patients anyway. With this program, they just pick up the clipboard that’s hanging by the bed and remind the patient about the pledge. It only takes a few seconds, but the impact is meaningful.”

Given the ease of the program and its potentially significant impact, Dr. Sinha was quick to recommend that other institutions consider adopting similar measures. “It is

in everybody’s interest—physicians, patients and overall health care system—to try to decrease the occurrence of falls, and this is one way to do that.”

John C. Gerancher, MD, professor of anesthesiology and section head of regional anesthesia and acute pain management at Wake Forest Baptist Health in Winston-Salem, N.C., agreed. “I believe the reality of patient falls is that patients are overwhelmed with instruction overload at the time of joint surgery and their nurses are overwhelmed

with patient overload,” he told Anesthesiology News. “The authors’ solution is a low-tech intervention that helps to cut through this overload and elevate a single issue—the dual responsibility patients and providers share for avoiding falls—to a higher level of attention.

“The authors have showed sustained results after a year,” Dr. Gerancher said.

“Every once in a while common sense works. We are going to try this.”

—Michael Vlessides

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14 I AnesthesiologyNews.com

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C LIN I C A L A N ESTHES IOLOGY

Condition ‘O’ Easing Strain on Laboring Mothers Hospital’s novel code seems to appeal to patients

A

n early look at a new type of emergency dispatch in which one call simultaneously reaches obstetricians, anesthesiologists, nurses and other experts in maternal and fetal care suggests the system is palatable to patients.

The findings, presented at the

annual meeting of the Society for Obstetric Anesthesia and Perinatology, describe patients’ reactions to Condition “O,” a type of emergency care for laboring women and their babies implemented in 2005 at Magee-Womens Hospital of the University of Pittsburgh Medical Center (UPMC).

Before the program was introduced, when an unborn baby’s heart rate dipped dangerously or the mother experienced heavy bleeding, the person present would call one clinician, who would call another, and so on, said Patricia Dalby, MD, an anesthesiologist at Magee-Womens who helped

conduct the new study (abstract 33).

Concerned about the time that chain of communication might take, a group of experts in emergency care developed a system in which one call to an operator would activate a batch alert to the phones and beepers of all maternal and fetal experts on call, as well as an overhead alarm. They decided to try it at UPMC, Dr. Dalby said, because the facility delivers nearly 11,000 babies per year. “It was developed to better treat these crucial emergencies that come up every once in a while,” she said.

The system is used only in serious emergencies, Dr. Dalby noted; within the past three years, no more than about 100 patients have experienced a Condition “O” dispatch.

But how patients would react to a potential barrage of responses from multiple clinicians was unclear. So then-medical student Brian Slater, MD, adapted a survey used for patients in the intensive care unit, asking women who experienced Condition “O” to indicate their satisfaction. Patients responded 48 hours after the emergency, and had the option of repeating the survey after another 24 hours, once they had had more time to recover from the event.

The researchers have questioned 25 women so far, and aim for 100 in total. The results so far are positive, Dr. Dalby said. Although women appear overwhelmed by the slew of activity during the emergency, they are more relieved to have it. “It appears that this type of system is efficient, and although like any emergency, a lot of people responding to it is concerning, the patient is somewhat reassured that there is a good emergency response to her particular needs,” she told Anesthesiology News.

Half of the patients and their families have rated their experience with the system at 1 or 2 on a 5-point scale, with 1 being excellent.

This type of rapid team response is specific to obstetrical patients, but has specific benefits for anesthesiologists, Dr. Dalby said. For instance, it provides early warning about problems they might find themselves treating in the operating room, such as maternal bleeding, fetal distress and shoulder dystocia. Knowing about these problems earlier gives anesthesiologists more time to prepare equipment and

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AnesthesiologyNews.com I 15

CL IN ICA L A N ESTHESIO L OGY operating rooms, and intervene earlier if possible, she noted.

The system likely has little impact on the hospital’s costs, Dr. Dalby added, because all of the people contacted are on call at the time regardless, and each emergency likely only lasts about 15 minutes. “We do not have any extra people being paid to do anything that they wouldn’t be paid to do anyway.

It is just a more efficient method of responding.”

One element of Condition “O” is slightly concerning to Krzysztof M. Kuczkowski, MD, an anesthesiologist at Drexel University College of Medicine and Hahnemann University Hospital,

both in Philadelphia, who did not participate in the study: Anyone—even patients—can activate the alert.

Still, calls generally come from the emergency room, postpartum areas, labor and delivery or triage, Dr. Dalby said. The patient’s nurse typically triggers the alert.

In principle, this would be a good idea, Dr. Kuczkowski said. But often a seemingly dangerous fetal heart rate is not so dangerous after all. “There have been many times when obstetricians

call for an emergency cesarean delivery, and you go to the operating room, and the heart rate has recovered,” he said. “I would probably leave the decision to an obstetrician.”

In addition, he speculated that any emergency response, whether from Condition “O” or another call involving multiple clinicians, will look the same to patients—many people rushing onto the scene simultaneously. “I do not think the environment will be any different from a patient’s point of

view, whether you have a Condition ‘O’ or not,” he said.

However, if at the end of the survey it appears the experience is truly overwhelming for patients, Dr. Dalby said, her hospital may consider cutting back on the number of people who respond to a Condition “O” dispatch. “We’re going to use this information to look at how better we can respond to this emergency.”

—Alison McCook

M7

Tips for Setting Up a Condition “O”-type Rapid Team Response Program

D I A G N O S T I C U LT R A S O U N D S Y S T E M

• All caregivers must believe such a team is needed and willingness to contribute a 24/7 response.

quality | flexibility | speed

• All participants must meet to decide who will be involved.

Responders generally are obstetricians, anesthesiologists, medical intensivists, respiratory care providers, critical care providers, neonatologists, and labor and delivery room clinicians.

• Hospitals must develop a way to efficiently call all respondents to a particular site at one time, such as on personal phones, an overhead page or beepers. It may make sense to designate two different notification systems, such as beepers and overhead pages.

• Notification operators must be briefed on the seriousness of these types of calls, how to pinpoint locations and follow up on calls if necessary.

• Hospitals must designate someone who can scale down the response team when it arrives to the most efficient size and personnel to handle a specific situation.

• It may help to designate someone to explain what is happening to the patient and her family.

• Participants can establish a debriefing process and review of the system to find ways to improve patient care and help caregivers.

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C LIN I C A L A N ESTHES IOLOGY

Boosting Dex Dose May Not Enhance Sedation

E

scalating doses of the drug dexmedetomidine may not offer greater sedation for critically ill patients, according to a retrospective review.

When dexmedetomidine (Precedex, Hospira) received FDA approval in 1999, it was anticipated that the drug would provide an alternative to other agents such as benzodiazepines.

In addition, because it does not cause respiratory depression, the agent was viewed as a way to help liberate patients from mechanical ventilation.

The FDA recommended an initiating dose of 1 mcg/kg of predicted body weight, followed by up to 0.7 mcg/kg per hour of continuous infusion for up to 24 hours.

“Based on more recent literature,

our hospital started allowing clinicians to dose dexmedetomidine up to 1.4 mcg/kg per hour and we wanted to evaluate the impact of this change on patients treated in the ICU [intensive care unit],” said Morgan Jones, PharmD, critical care pharmacy resident at the Ohio State University Medical Center, in Columbus, and lead author of the study. Dr. Jones and

It’s okay to

reuse with Pall

his colleagues presented their findings at the 2011 annual meeting of the Society of Critical Care Medicine in San Diego (abstract 759), and published their findings in the June 2011 issue of the Annals of Pharmacotherapy.

Previous research had hinted at the safety and efficacy of higher doses, but failed to provide a direct comparison to doses in the FDA-approved labeling, Dr. Jones noted.

In the new study, Dr. Jones and his colleagues identified 133 patients in the ICU who received dexmedetomidine for continuous sedation. Patients were considered to be in the low-dose group if their maximum dose was less than or equal to 0.7 mcg/kg; a high dose was considered any dose exceeding 0.7 mcg/kg.

The researchers then evaluated which patients maintained a Richmond Agitation and Sedation Scale (RASS) score in the goal range of –1 to +1, the recommended sedation level at the researchers’ home institution.

To the team’s surprise, the percentage of RASS scores maintained in the goal range was greater in the 90 patients receiving low doses than the 43 patients in the high-dose group: 60% versus 49%, respectively (P=0.03; Figure 1).

Although the researchers found no difference in the rate of oversedation between the two study groups, 19% of RASS scores for patients who received a high dose of dexmedetomidine indicated undersedation, compared with 5% in the group that received a low dose of the drug (P=0.05).

Approximately 38% of all patients 70

Median of RASS Scores, %

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Low Dose High Dose

P=0.03 60

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w: www.pall.com/reuse e: hospitalfilters@pall.com p: 866.347.3428 © 2011 Pall Corporation. Pall, , and Ultipor are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. GN11.7020

Figure 1. Sedation efficacy of dexmedetomidine.

RASS, Richmond Agitation and Sedation Scale

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CL IN ICA L A N ESTHESIO L OGY

35 30

high-dose group may have had many reasons why they were harder to sedate.

Additionally, the abstract doesn’t tell us the actual doses these patients received.

“I will tell you from personal experience that if you increase dexmedetomidine high enough most patients will be sedate,” added Dr. Candiotti, a member of the editorial board of Anesthesiology News. “Overall, the abstract raises some interesting points and the subject warrants further study.”

Dr. Jones offered one suggestion for anesthesiologists in the critical care setting: “Every patient that you evaluate for the use of dexmedetomidine is going to respond differently,” he said.

“It’s important to individualize the use of the medication and take a close look at how the patient is reacting to determine if they are an ideal candidate or if they should be switched to another sedative agent.”

—Lynne Peeples

Contact

the editor of Anesthesiology News

ama rcu s

experienced hypotension, the most common adverse effect (Figure 2).

“If a patient hasn’t achieved adequate sedation within FDA-approval dose range, they may not achieve it with dose escalation,” Dr. Jones said.

Indeed, patients in the high-dose group were twice as likely as those in the low-dose group to require additional sedatives eight hours after first administration, the investigators found (Figure 3).

The researchers hypothesized that genetic polymorphisms within the medication’s target, the central a2 receptor, could predispose some patients to not respond to dexmedetomidine. However, no evidence exists of such a link.

Study limitations could also explain the surprising results, said Keith Candiotti, MD, an anesthesiologist at the University of Miami, in Florida, who has consulted for Hospira.

“The spectrum of drug requirements for ICU sedation can be quite large,” Dr. Candiotti said. “Since the study was retrospective, the patients in the

onmed.com mah c m @

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NAROPIN® was associated with more spontaneous vaginal deliveries and fewer instrumented deliveries than bupivacaine.1-3 A Block Well Done.

An 18% higher proportion of spontaneous vaginal deliveries and a 32% lower proportion of instrumented deliveries were observed in patients who received NAROPIN vs bupivacaine (P<0.05; P<0.01).2 To learn more about the clinical benefits of NAROPIN in labor and delivery, visit www.naropin-us.com.

0

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs.

Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions.

In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

Important Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com.

Please see accompanying brief summary of Prescribing Information. www.naropin-us.com

Dosing Group Figure 3. Use of additional sedatives.

NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management.

1. NAROPIN Prescribing Information. Data on file. 2. Writer WDR, Stienstra R, Eddleston JM, et al. Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis. Br J Anaesth. 1998;81:713717. 3. Asik I, Göktug A, Gülay I, Alkis N, Uysalel A. Comparison of bupivacaine 0.2% and ropivacaine 0.2% combined with fentanyl for epidural analgesia during labour. Eur J Anaesthesiol. 2002;19:263-270.

Naropin® and logo are registered trademarks of APP Pharmaceuticals, LLC. and APP ® are registered trademarks of APP Pharmaceuticals, LLC. ©2011, APP Pharmaceuticals, LLC. All Rights Reserved. 0173-NAR-05-4/11

WHY COMPROMISE?

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C LIN I C A L A N ESTHES IOLOGY

Protein Shake During Labor Promotes Patient Satisfaction Ongoing study seeks to reassess strict NPO policy

P

regnant women undergoing a normal course of labor may be able to safely consume food or drink while receiving epidural anesthesia, thereby increasing their perception of satisfaction. Researchers at Magee-Womens Hospital of the University of Pittsburgh Medical Center, in Pittsburgh,

found that laboring women who drank a high-protein shake reported more satisfaction than those who were allowed only ice chips, with no increase in complications. The study results were presented at the 2011 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract 25).

Naropin

®

(ropivacaine HCl) Injection

BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.

CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving

A strict policy of nothing by mouth (NPO) is imposed during labor to reduce maternal morbidity and mortality, said senior author Manuel C. Vallejo, MD, professor and director of obstetric anesthesia at the Pittsburgh hospital. But the widespread use of regional anesthesia and improved

bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions).

Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.)

ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin.

Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)

Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis

N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18

Naropin total N=1661

(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)

N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13

Bupivacaine total N=1433

(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)

Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)

Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia

N 77 49 42 18 17 14 13 13 11 10 8

Naropin total N=1661

(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)

N 68 47 38 14 18 15 14 12 10 8 16

Bupivacaine total N=1433

(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

general anesthetic techniques have significantly decreased the incidence of maternal aspiration, he said. Facilities in Northern Europe, including Switzerland, have adopted a less restrictive NPO policy.

Dr. Vallejo said women undergoing chemotherapy for cancer have been found to experience less nausea and vomiting when they follow a diet high in protein. If women could consume something high in protein while in labor, he thought it might also help them.

In the study, 67 laboring women were randomized to one of two experimental conditions: an 11-ounce shake containing 30 grams of protein and ice chips, or ice chips only, following placement of the epidural. The participants had to be at a stage of cervical dilation of 5 cm or less and at least 36 weeks of gestation with a singleton pregnancy, and were required to have had nothing by mouth for at least four hours; the fetus had to be in a vertex position. Women were excluded if they had diabetes, multiple gestation or a history of obstetric complications or chronic opioid use; also excluded were morbidly obese patients.

All patients received patient-controlled epidural anesthesia of 0.08% bupivacaine with 2 mcg/mL of fentanyl. The researchers monitored the patients for episodes of nausea and vomiting at hourly intervals until delivery. After delivery, participants were asked to rate their overall satisfaction.

Overall, 21.4% of women in the protein-shake group had nausea, compared with 33.3% in the ice-chips group (P=0.43). In the protein-shake group, 10.7% of the women experienced vomiting, compared with 12.8% of the ice-chips group (P=0.91). Average satisfaction scores were 92 out of 100 in the protein-shake group and 90 out of 100 in the ice-chips group (P=0.05). Aspiration did not occur in any of the patients, and none required a general anesthetic. Two women in the protein-shake group and five women in the ice-chips group had a cesarean delivery.

Dr. Vallejo told Anesthesiology News that as long as women have a functioning epidural and normal progression of labor, “it’s probably OK to have something to eat or drink. It’s good for the see shake page 23

APP Pharmaceuticals, LLC

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CL IN ICA L A N ESTHESIO L OGY Equation continued from page 1 Hospital of University of Pittsburgh Medical Center. He keeps an index card version of the chart and gives it to all residents when they are attempting to insert an epidural. “It gives you an estimation of where you want to be,” Dr. Vallejo told Anesthesiology News.

“And, I feel a lot better when residents use it.”

Ultrasound helps find the epidural space, he added, but in overweight and obese patients—who make up nearly 70% of the U.S. population—the image will reveal mostly fatty tissue. In these patients, it also is difficult to find normal anatomic landmarks, such as the hips and spinous processes. Indeed, research has shown that morbid obesity (BMI ≥40 kg/m2) is associated with an increased failure rate of up to 5% for epidurals.

Previously, Dr. Vallejo and his colleagues tested the equation on normal-weight women in labor and found that it predicted the distance from the skin to the epidural space with high accuracy (Pearson CC, 0.91). “Anything above 0.81 is considered a high

Manuel C. Vallejo, MD

correlation,” he said. His team also has shown that using ultrasound helps trainees reduce their rate of failed epidural placements.

Given the utility of both tools, the investigators decided to combine them into one technique. “If the ultrasound reveals a lot of fatty tissue, the equation helps trainees know where to look for the epidural space in that image,” Dr. Vallejo said.

To investigate, he and his colleagues asked trainees to use the equation to calculate the distance from the skin to the epidural space in 56 morbidly obese women; the trainees then combined the technique with ultrasound

for transverse and longitudinal views.

An experienced anesthesiologist trained in using ultrasound then measured the actual distance to the epidural space.

Dr. Vallejo found that the equation used in conjunction with ultrasound resulted in a Pearson CC greater than 0.85. The epidural distance equation used alone was less predictive (CC, 0.59). Trainees using the combined technique of equation and ultrasound located the space in morbidly obese patients after a median of two attempts, with no accidental dural punctures.

It is not unusual that multiple attempts are necessary in a morbidly obese patient, Dr. Vallejo said, simply because it is so difficult to estimate the distance to the epidural space. “I think that the equation—especially if you’re just learning—in conjunction with ultrasound would be much better than ultrasound, especially in the morbidly obese.”

“I think this is a good study,” said Jose Carvalho, MD, PhD, director of obstetric anesthesia at Mount Sinai Hospital, in Toronto, Canada. At

his facility, clinicians use ultrasound to measure the epidural space in all patients, especially obese women. “We never do it without ultrasound,” he said.

However, Dr. Carvalho questioned whether the equation presented by Dr. Vallejo’s team adds much to the accuracy. A Pearson CC of 0.59 for the equation alone is not very impressive, he said. And, he added, a CC does not tell the whole story, such as the size of the limits of agreement.

It is difficult to find a formula that works in obese women because fat distribution can vary, Dr. Carvalho said.

Some patients with a high BMI may not have much back fat, and vice versa.

So, an equation based solely on anthropometric variables, such as height and weight, will not be equally useful for all patients. He suggested that clinicians focus training on the most useful technique, ultrasound. “I think the only way to determine epidural depth is ultrasound,” Dr. Carvalho said.

“That is the only method; equations will never be the answer.”

—Alison McCook

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C LIN I C A L A N ESTHES IOLOGY INR continued from page 1

University—sought to tackle the controversy that the ASRA guidelines may be 1.4,” said Pamela M. Shaw, BS, assistant too conservative. research coordinator at the Hospital for A total of 4,365 patients—3,211 proSpecial Surgery in New York City, one spective and 1,154 retrospective—were of the three institutions participating in enrolled in the observational study. All the investigation. “However, those rec- patients underwent total joint replaceommendations are generally based on ment followed by daily warfarin thromexpert consensus, as opposed to a large- boprophylaxis. All patients had normal scale study.” coagulation test results prior to surgery; The investigators—including nonsteroidal anti-inflammatory drugs researchers from Rush University Med- (NSAIDs) and anticoagulants were ical Center and Thomas Jefferson withheld prior to surgery.

‘I’ve actually heard people say that it would be less dangerous to pull the catheter out as quickly as possible. When you do that […] it makes the catheter more like a razor. So careful removal is critical.’

—John C. Rowlingson, MD The mean age of the participants was 68 years, and their mean weight was 81 kg. Most (79%) underwent total knee replacement surgery. The mean duration of epidural analgesia was 2.1±0.6 days.

Epidural analgesia was discontinued following institutional protocol.

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Only patients with an INR greater than 1.4 when their epidural catheter was removed were included in the study. Participants were followed twice a day by the acute pain service, and neurologic checks were performed every two hours for 24 hours after removal. No other anticoagulants except NSAIDs were administered.

Ms. Shaw reported at the 2011 ASRA annual meeting (abstract 54) that although the mean INR at time of epidural removal was 1.9±0.4, no spinal hematomas were observed.

Yet Ms. Shaw, whose poster was named one of the best at the meeting, noted that catheters were removed when warfarin therapy was initiated—a time when several vitamin K factors are likely to be adequate for hemostasis.

The findings, she added, do not necessarily contradict current ASRA guidelines, as the researchers followed recommendations to cautiously remove catheters and perform subsequent neurologic checks.

“The guidelines are basically drawing a line in the sand,” said John C. Rowlingson, MD, professor of anesthesiology and director of the Acute Pain Center at the University of Virginia in Charlottesville. “Then we have to decide over time and given the data, whether that line is a good line or a bad line. And these kinds of studies are crucial in terms of helping us understand how much more safety data we need.”

J.C. Gerancher, MD, professor of anesthesiology and section head of regional anesthesia and acute pain management at Wake Forest Baptist Health in Winston-Salem, N.C., pointed to the interindividual variation in INR levels known to be associated with initiation of therapy. “I thought it was remarkable how high some of these INRs were, especially since these patients all likely received comparable doses of anticoagulants,” Dr. Gerancher said.

Dr. Rowlingson urged clinicians to consider removing the catheter as carefully as possible in anticoagulated patients.

“I’ve actually heard people say that it would be less dangerous to pull the catheter out as quickly as possible,” he said. “When you do that—particularly with a wire-armored catheter—it makes the catheter more like a razor. So careful removal is critical.”

—Michael Vlessides

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AnesthesiologyNews.com I 21

CL IN ICA L A N ESTHESIO L OGY

Bariatric Surgery in Elderly Safe, Provided Thorough Evaluation Chicago—Proceed, but proceed with caution.

This was the advice given to attendees of the 2011 Digestive Diseases Week when considering bariatric surgery for individuals older than age 65 years (abstract 804). Researchers found older patients had significantly longer postoperative hospital lengths of stay (LOS) but similar 30-day mortality rates compared with younger patients.

“We’re certainly not giving a green light to operate without considering risk factors, but it’s important to note that age alone is not a contraindication for bariatric surgery,” said lead investigator Robert Dorman, MD, PhD, a surgery resident at the University of Minnesota Medical School, in Minneapolis. “Thorough perioperative evaluations should ensure the modest mortality rate that we found remains low.”

According to Dr. Dorman, in 2005, an estimated 1.9% of all bariatric procedures were performed in adults older than 65 years. That percentage has now risen to 4.8%, which is why it has become increasingly important to investigate the safety of these procedures in older individuals, he said.

Prior research has shown that older patients are more likely than their younger counterparts to suffer adverse events (AEs), including death, following bariatric surgery; however, Dr. Dorman noted these findings did not adequately account for possible confounding variables (JAMA 2005;294:1903-1908).

To conduct a more complete analysis, Dr. Dorman and colleagues examined data from 48,378 obese individuals registered in the 20052009 American College of Surgeons’ National Surgical Quality Improvement Program (NSQIP) database. The patients had a body mass index (BMI) greater than 35 kg/m2 and had undergone either open or laparoscopic Rouxen-Y gastric bypasses, open duodenal switches, laparoscopic adjustable gastric banding procedures or vertical banded gastroplasties. The investigators compared LOS, major AEs and 30-day mortality rates among 1,994 individuals in the database who were older than 65 years with the rest of the study population. They conducted multivariate analyses to control for the effects of surgical approach, BMI and comorbidities.

The researchers found a 0.4% mortality rate among older individuals, which was not significantly higher than the 0.12% and 0.21% mortality rates among those aged 35 to 49 (odds ratio [OR],

3.3) and 50 to 64, respectively. Older individuals were significantly more likely than younger patients to be in the 90th percentile for hospital LOS (OR, 2.1 for open procedures; P<0.01; OR, 1.2 for laparoscopic surgeries; P<0.01).

They also found that, after controlling for potential risk factors, patients over 65 were no more likely than younger patients to suffer postoperative stroke or

cardiac arrest following either an open or laparoscopic procedure.

Melinda Maggard Gibbons, MD, who was not involved in the study, noted that although these data are encouraging, they do not indicate the long-term mortality associated with conducting these procedures in the elderly. “Other surgical procedures have been associated with an increased risk

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for mortality up to one year postoperatively in the older population,” said Dr. Gibbons, assistant professor of surgery at the University of California, Los Angeles Medical School. “Given the size and scope of the NSQIP database, this would be a good place to look for an answer to this question.”

—David Wild

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Post-Heart Transplant, Hospital Admissions Often Are Drug-Related San Diego—Drug-related problems were determined to be the primary cause of hospital admissions in 40% of heart transplant patients treated at a Missouri center, according to a study presented at the annual meeting of the International Society for Heart and Lung Transplantation.

More than half of the drug problems were deemed to be preventable, reported co-investigator Kristin Repp, PharmD, clinical pharmacy coordinator at Saint Luke’s Northland Hospital, in Kansas City.

Drug-related problems in the 300 patients studied were classified by

type, pharmacologic class and impact on hospital length of stay (LOS). The researchers used the Adverse Drug Reaction Scale (Naranjo algorithm) to rank the reactions according to 10 items, labeling them as definite (>9), probable (5-8), possible (1-4) or doubtful (0).

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During the three-month study period, 48 cardiac transplant patients were hospitalized. The mean time from transplant was 4.5 years. Mean number of medications on admission was 16, with an average of eight chronic diseases noted per patient.

There were no differences in gender, age, admitting serum creatinine level, number of medications, number of chronic disease states or time from transplant.

Drug-related problems accounted for 19 of 48 admissions (40%), 11 of which were considered preventable (58%), Dr. Repp reported. The types of drug-related problems included adverse drug reactions (32%), supratherapeutic dosage (32%), subtherapeutic dosage (16%), untreated indications (11%), nonadherence (5%) and drug interaction (5%). No admissions were attributed to improper drug selection or drug prescription without an indication. Pharmacologic classes implicated included immunosuppressants (63%), antimicrobials (11%), electrolytes/fluids (11%), anticoagulants (5%), antiseizure agents (5%) and other classes (5%).

One preventable case involved a patient started on valganciclovir who developed gastrointestinal upset but presented only after becoming severely dehydrated, and as a consequence was found to have decreased renal function and reduced clearance of tacrolimus.

This was classified as a supratherapeutic dose of tacrolimus and a preventable problem. A problem that was deemed unpreventable involved a patient with a complicated medical course and recent history of urosepsis and pneumonia. The patient, who was already on three immunosuppressive medications, was prescribed antibiotics and later admitted to the hospital for a Clostridium difficile infection that was most likely secondary to the immunosuppressant and anti-infective drug therapy. “It is unlikely that medication changes would have prevented this event,” Dr. Repp said.

The drug problems documented in the study were associated with longer hospital LOS: mean 11.4 days versus 8.5 days for admissions not related to drugs, although the difference was not statistically significant (P=0.458).

“When annualized, we determined that 44 hospitalizations or 500 hospital days could be prevented,” she said.

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AnesthesiologyNews.com I 23

CLINICAL ANESTHESI OLOGY ‘We see twice the national average for drug-related problems in our cardiac transplant patients because of polypharmacy.’

—Michael A. Shullo, PharmD

A Challenging Population The results underscore the challenge of treating these complicated patients.

“In the general population, drug-related problems are less of a problem—they cause about 15% of all hospital admissions and approximately 30% are preventable,” Dr. Repp said. “Cardiac transplant patients, in contrast, are clearly at an increased risk, based on our results, and it may be due to their complicated medication regimens, which include drugs with narrow therapeutic windows.” The drug problems uncovered in the study “also underscore the need for multidisciplinary care,” she stressed.

national average for drug-related problems in our cardiac transplant patients because of polypharmacy,” he said.

“Drug therapy has profound potential for multiple interactions, and pharmacists must be diligent about verifying these adverse events.”

Dr. Shullo said that although electronic medical records do capture drug-related problems, they do so “at a very sensitive level that often is not clinically relevant. In transplant, there are drug–drug interactions and there are dynamic interactions that are not captured nearly as well.”

Patients may have a drug added to their treatment regimens without the knowledge of the transplant pharmacist, Dr. Shullo continued. “At the University of Pittsburgh, the most common interaction is generally one caused by [someone] not on the transplant team, adding a product that normally would be good for patient care but is not so good for the transplant patient. We count on the dispensing pharmacist to be alert to things that do not seem right.”

Dr. Repp agreed that the pharmacist’s role is crucial in this setting. In fact, “at Saint Luke’s, is a result of our research, we increased the number of pharmacists dedicated to [cardiac] polypharmacy, and we provide a better continuum of care between inpatient and outpatient services. This position is still evolving and we have not remeasured to quantify its impact. But as Dr. Shullo pointed out, we not only need transplant pharmacists watching for drug-related problems, but community pharmacists as well. We all need to be diligent in identifying these problems.”

—Caroline Helwick

Polypharmacy Among Culprits Michael A. Shullo, PharmD, assistant professor at the University of Pittsburgh School of Pharmacy and clinical pharmacist for the transplant service, said the findings are no Drs. Repp and Shullo reported no relevant surprise to him. “We see twice the conflicts of interest.

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Shake continued from page 18

said he was encouraged by the results showing high patient satisfaction women’s well-being, and it increases scores in both groups—that he is not patient satisfaction.” He said the study negatively affecting his patients treated is ongoing, and now includes about by NPO. 107 women. Some patients who heard “It’s reassuring for those who want about the study have asked to partici- to offer their patients something, but pate, he said. for those who still practice NPO, it’s Andrew Malinow, MD, director of also reassuring to know that we’re not obstetric anesthesiology at the Uni- compromising patient satisfaction,” versity of Maryland Medical Center, Dr. Malinow told Anesthesiology News. in Baltimore, said he will remain an He suggested that clear liquids with NPO practitioner for now because his fiber or carbohydrate-containing liqpractice serves a population composed uids also might help women feel full mainly of high-risk and morbidly while decreasing the risk for aspiration. obese pregnant women. However, he —Karen Blum

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P OLI C Y & M A NAGE MENT

Looking Ahead: The Next Decade in Anesthesia Products

Market Value Trend (US$ Millions)

Hospital AIMS ASC AIMS Growth

2007 2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2008

2009

Annual Growth Rate

Annual Growth Rate

Market Value Trend (US$ Millions)

H

ow much will hospitals and practices spend anesthesia products growing? Vancouver, B.C.-based for all—well, many­—things anesthesia. Below are some on anesthesia information management sys- iData Research Inc. (http://www.idataresearch.net/) of their projections (figures reprinted with permission; tems in 2014? Is demand for disposable recently released its outlook on the state of the market iData declined to provide precise dollar amounts).

2010

2011

2017

2012

2013

2014

2015

2016

2017

Year

Year

Chart 1-1. Anesthesia, Respiratory and Sleep Management Device Market, United States, 2007–2017.

Chart 1-4. Total Anesthesia Information Management System Market by Segment, United States, 2007–2017.

Source: iData Research Inc.

Source: iData Research Inc.

Philips/Philips Respironics

Ambulatory Surgery Centers

Disposable Laryngeal Masks

Hospitals

AirSep

Endotracheal Tubes

Chart 1-12. Leading Competitors, Anesthesia, Respiratory and Sleep Management Device Market, United States, 2010

Source: iData Research Inc.

Source: iData Research Inc.

Source: iData Research Inc.

Annual Growth Rate 2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

Market ValueTrend (US$ Millions)

Chart 1-5. Anesthesia Disposables Market by Segment, United States, 2010.

Market Value Trend (US$ Millions)

Chart 1-3. Anesthesia Monitor Unit Sales by Location of Application, United States, 2010.

Oxygen Cannulae Oxygen Masks Segment 3 Segment 4

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

Year

Year

Chart 1-2. Anesthesia Delivery Unit Market, United States, 2007–2017.

Chart 1-8. Respiratory Disposables Market by Segment, United States, 2007–2017.

Source: iData Research Inc.

Source: iData Research Inc.

PRINTER-FRIENDLY VERSION AT ANESTHESIOLOGYNEWS.COM

Opioid Adjuvants for Multimodal Pain Management

KEITH CANDIOTTI, MD

MELVIN C. GITLIN, MD, FACPM

MICHELLE MINA-CILIBERTI, MD

Vice Chairman Clinical Research Chief, Division of Perioperative Medicine, University of Miami Department of Anesthesiology, Perioperative Medicine and Pain Management Miami, Florida

Professor and Vice Chairman for Clinical Affairs Department of Anesthesiology University of Miami Miller School of Medicine Miami, Florida

Fellowâ&#x20AC;&#x201D;Pain Management University of Miami Department of Anesthesiology, Perioperative Medicine and Pain Management Miami, Florida

Dr. Candiotti has received research and/or consulting funding from Cadence Pharmaceuticals, Cumberland Pharmaceuticals, Ortho-McNeil, Pfizer, and Purdue Pharma.

Drs. Mina-Ciliberti and Gitlin report nothing to disclose.

C

hronic pain has become a significant diagnostic and therapeutic concern for many practitioners. With the cost of treatment estimated at more than $100 billion in the United States alone,1 along with attendant decreases

in quality of life and productivity, physicians must be familiar with chronic pain as both major public health and economic issues. The origins of chronic pain are manifold, and include trauma, degenerative disorders, and other causes. Increasing evidence shows that uncontrolled pain after surgery is a significant risk factor for the development of chronic pain. Efforts to manage pain in the perioperative period therefore may be effective in reducing the burden of chronic pain, both for patients and as a public health problem.

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

A N E S T H E S I O L O G Y N E W S â&#x20AC;˘ J U LY 2 0 1 1

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Table 1. Nonopioid Medications With Efficacy for Treating Perioperative Pain Nonsteroidal Anti-inflammatory Drugs Salicylates

Propionic acid derivatives

SSRIs

Aspirin

Fluoxetine

Diflunisal

Fluvoxamine

Salsalate

Paroxetine

Fenoprofen

Sertraline

Flurbiprofen Ibuprofen

Serotonin and norepinephrine reuptake inhibitors (SNRIs)

Venlafaxine

Naproxen Oxaprozin

Anticonvulsants Carbamazepine

Diclofenac

Lamotrigine

Ketorolac

Oxcarbazepine

Meclofenamate

Phenytoin

Mefenamic acid

Valproic acid

Tolmetin

Topiramate

Enolic acid derivatives (oxicams) Meloxicam Nabumetone

ι2δ-subunit calcium channel

Gabapentin

Etodolac Indomethacin

Muscle relaxants Cyclobenzaprine

Sulindac COX-2 selective (coxibs)

Tizanidine

Celecoxib Topical agents

Antidepressants TCAs

Capsaicin

Amitriptyline

Diclofenac

Clomipramine

Lidocaine

Desipramine Imipramine Maprotiline Nortriptyline MAOIs

Baclofen Pregabalin

Piroxicam Acetic acid derivatives

Desvenlafaxine Duloxetine

Ketoprofen

Fenamates

Citalopram

Selegiline

Other analgesics Para-aminophenol derivative

Acetaminophen

COX, cyclooxygenase; MAOI, monoamine oxidase inhibitors; SNRI, serotonin norepinephrine reuptake inhibitor; SSRI, selective serotonin receptor inhibitor; TCA, tricyclic antidepressant

Tranylcypromine

Treatment options for patients with chronic pain include pharmacologic, psychological, surgical, nerve blocks, and rehabilitative strategies. Among the pharmacologic approaches, the use of opioids for the treatment of noncancer pain is particularly controversial.

The potential for adverse effects (AEs) of these drugs,

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along with the risk for misuse and diversion and the well-publicized potential for opioid-related AEs, have prompted increased discussion of the utility of alternative analgesic and opioid-sparing medications.

This review focuses on so-called opioid adjuvant analgesics (Table 1). These medications traditionally are

defined as a diverse group of drugs originally developed for a primary indication other than pain but that nonetheless have analgesic properties.2 Many of these medications are being used to enhance analgesia under specific circumstances. Broadening their application could ease or eliminate the concerning dependence on opioids as monotherapy for pain relief.

The major therapeutic principle underlying the use of opioid adjuvants is to achieve a balance between increasing analgesic efficacy while minimizing AEs. Adjuvant analgesics have been recommended when the toxic limit of a primary analgesic is reached or the therapeutic benefit of a primary analgesic has plateaued.

These drugs also can be beneficial in the presence of disabling nonpainful complaints such as insomnia, depression, anxiety, and fatigue that may cause deterioration of the patient’s quality of life and function.3

Types of Opioid Adjuvants NONSTEROIDAL ANTI-INFLAMMATORY DRUGS Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most widely prescribed and consumed medications in the world.4 These drugs have analgesic, antipyretic, and anti-inflammatory activity through the inhibition of prostaglandin synthesis. Selective cyclooxygenase-2 (COX-2) inhibitors have the additional benefit of the reduction of the incidence of gastrointestinal (GI) side effects. The SUCCESS-I study compared the safety and efficacy of COX-2 inhibitors versus nonselective NSAIDs in 13,274 patients with osteoarthritis. Celecoxib (Celebrex, Pfizer) was found to be as effective as the nonselective NSAIDs as measured by patients’ assessment of arthritis pain, as well as joint stiffness and function.5 GI-related complications were significantly less common among patients taking celecoxib than among those receiving traditional NSAIDs. Cardiothromboembolic events were infrequent and comparable for the 2 arms of the study.5

A Cochrane review of 65 trials showed that nonselective NSAIDs were slightly effective for short-term symptomatic relief in the treatment of patients with acute and chronic low back pain without radicular symptoms and that patients treated with COX-2 agents, although not getting superior pain relief, reported fewer side effects.6 Related to COX-2 agents is the drug meloxicam, an oxicam derivative thought to be relatively COX-2 preferential at low therapeutic doses.7 A recent study demonstrated that NSAIDs reduce the morphine requirement in patient-controlled analgesia after major surgery with a concomitant reduction in morphinerelated side effects such as postoperative nausea, vomiting, and sedation.8 Both celecoxib and ibuprofen (an IV form of ibuprofen [Caldolor, Cumberland Pharmaceuticals] approved by the FDA in 2009) have been reported to diminish pain after ambulatory surgery, enhancing both the quality of recovery and patient satisfaction.9 NSAIDs have been included in practice guidelines for acute pain management in the perioperative setting.10

NON-NSAID ANALGESICS The platelet-sparing properties of the non-NSAID acetaminophen, which has recently become available in an IV preparation in the United States (Ofirmev, Cadence Pharmaceuticals), and selective COX-2 inhibitors make them appropriate for most patients as part of multimodal analgesia in the perioperative setting.11

ANTIDEPRESSANTS Antidepressants have several mechanisms of action including inhibition of the reuptake of norepinephrine and serotonin, calcium channel blockade, sodium channel blockade, N-methyl-D-aspartate receptor antagonism, and activation of opioid receptors.12 They have been widely used for the treatment of neuropathic pain, a group of disorders characterized by damage or dysfunction of the central or peripheral nervous systems. They have been classified based on their mode

Case 1 A 52-year-old woman complained of severe pain on day 1 following a right radical mastectomy and lymph node dissection. She was receiving morphine by self-administration pump in escalating dosages but without relief, and began experiencing nausea and vomiting. She described her pain as aching, stabbing, and burning.

In response to her complaints, IV administration of 1,000 mg of IV acetaminophen (Ofirmev, Cadence Pharmaceuticals) and 400 mg of IV ibuprofen (Caldolor, Cumberland Pharmaceuticals) every 6 hours was initiated. The patient was treated with antiemetics and her morphine dose was decreased. When the patient’s nausea abated, she was started on oral

gabapentin, at a dose of 100 mg twice daily.

By postoperative day 2, the patient’s pain complaints had greatly diminished. Her morphine was discontinued and she was converted to 5 mg of oral oxycodone with 325 mg of acetaminophen orally every 4 hours as needed. She was converted to 100 mg of celecoxib (Celebrex, Pfizer) twice daily, and her gabapentin was maintained at 100 mg 3 times per day. She was discharged that afternoon.

In this case, opioid monotherapy not only produced inadequate analgesia for the patient but also resulted in unpleasant, poorly tolerated side effects.

Instituting multimodal therapy with opioid adjuvant analgesics led to rapid, marked improvement.

A N E S T H E S I O L O G Y N E W S • J U LY 2 0 1 1

3

Case 2 A 57-year-old man is scheduled to undergo left knee replacement. His medical history is significant for hypertension and chronic obstructive pulmonary disease. He is a nonsmoker and drinks alcohol socially.

The patient has had chronic pain in his left knee, for which he has been taking ibuprofen (800 mg twice daily) chronically. For periodic episodes of breakthrough pain, he has taken 5 mg oxycodone with 325 mg of acetaminophen once or twice a day. He requested that the use of opioids postoperatively be limited as much as possible.

On the day of his surgery he is given 400 mg celecoxib (Celebrex, Pfizer), along with 150 mg pregabalin (Lyrica, Pfizer), both orally, with a sip of water

of action and include traditional tricyclic antidepressants (TCAs), reversible inhibitors of monoamine oxidase inhibitors type A, selective serotonin reuptake inhibitors (SSRIs), and selective norepinephrine reuptake inhibitors (SNRIs).13 A 2007 Cochrane review assessed the effectiveness and safety of antidepressant drugs in the treatment of neuropathic pain.14 Sixty-one trials of 20 antidepressants were considered eligible for inclusion. TCAs and SSRIs had a number needed to treat (NNT) of approximately 3. No study of SNRIs was included. Meta-analyses evaluating the effectiveness of TCAs and SSRIs in the treatment of fibromyalgia have shown that both types of medications improve a patient’s sense of wellbeing, sleep pattern, fatigue, and pain.15 A 2009 study explored antidepressant dose- or concentration-response relationships in achieving optimal analgesia for the treatment of chronic pain and affirmed that TCAs produce analgesia in much lower doses than those required for an antidepressant effect.16 Failure to respond to treatment with these agents might indicate low drug concentrations owing to poor compliance or absorption. It has been suggested that monitoring drug concentrations might prove useful in cases of treatment failure, noncompliance, drug–drug interaction, and severe adverse reactions.16

ANTICONVULSANTS Anticonvulsants are another commonly used family of adjuvant analgesics. The basis for the effectiveness of anticonvulsants for the treatment of neuropathic pain appears to be related to a shared pathophysiology with epilepsy17; both conditions are characterized by neuronal hyperexcitability. The hyperexcitable state of neuropathic pain is marked by reduced thresholds (sensitization) and ectopic discharges at the spinal dorsal horn or dorsal root ganglion.18 Among the mechanisms of action of anticonvulsants are the modulation of voltage-gated sodium and calcium (specifically, the α2δ-subunit) channels and

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before entering the operating room. The surgery is performed under spinal anesthesia augmented by a single shot femoral block with ropivacaine. Approximately 30 minutes before the end of surgery, the patient is given 1 g IV acetaminophen (Ofirmev, Cadence Pharmaceuticals).

Twelve hours after surgery, the patient receives another dose of celecoxib (200 mg) and 150 mg of pregabalin. He also receives 650 mg of acetaminophen orally for primary pain control every 6 hours.

IV morphine is used sparingly to control moderate to severe breakthrough pain in the first 24 hours after surgery. The patient reports good pain control and minimal opioid-related side effects.

inhibition of γ-aminobutyric acid (GABA).19 Anticonvulsants that have received FDA approval for neuropathic pain include carbamazepine for trigeminal neuralgia; gabapentin for postherpetic neuralgia (PHN); and pregabalin (Lyrica, Pfizer) for PHN, diabetic peripheral neuropathy, and fibromyalgia. Multiple studies have demonstrated their efficacy. Both gabapentin and pregabalin have few drug–drug interactions, and their route of renal excretion may offer an advantage for patients with hepatic compromise.20-23 Pregabalin provides the potential benefits of relatively rapid titration, linear pharmacokinetics, and an early onset of analgesia.24 Dose-dependent AEs include somnolence, dry mouth, dizziness, and edema. Gabapentin demonstrates nonlinear pharmacokinetics; its adverse reactions are similar to those of pregabalin.25 Carbamazepine has been demonstrated to be of potential value in the treatment of trigeminal neuralgia. Its analgesic properties derive from its ability to block voltage-dependent sodium channels, resulting in membrane stabilization and decreased discharges from ectopic nerves.26 Common side effects of carbamazepine include dizziness, nausea, drowsiness, blurred vision, and ataxia. More serious reactions may include leukopenia, liver dysfunction, and hyponatremia.26 Oxcarbazepine is a ketoanalog of carbamazepine.

It binds to sodium channels in their inactive state, increases potassium channel conductance, and modulates high-voltage–activated calcium channels.27 Oxcarbazepine is used as a second-line agent in trigeminal neuralgia for patients who fail to respond to carbamazepine.28 It also may be effective in the treatment of painful diabetic neuropathy.29 Phenytoin is one of the oldest adjuvant analgesics. It inhibits the presynaptic release of glutamate and blocks sodium channels.30 The NNT of phenytoin for effectiveness in the treatment of painful diabetic neuropathy has been reported as 2.1 (95% confidence interval, 1.5-3.6).31 Potential AEs include nystagmus, ataxia, slurred speech, decreased coordination, mental confusion, nausea,

vomiting, constipation, hepatic compromise, thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without suppression of bone marrow.32 Lamotrigine has shown some efficacy for trigeminal neuralgia that is resistant to carbamazepine.33 The analgesic effect of lamotrigine appears to result from its blockade of tetrodotoxin-resistant sodium channels and from an inhibition of glutamate release from presynaptic neurons.34 Lamotrigine has been studied in both animals and humans and may reduce pain associated with a variety of conditions including diabetic neuropathy, multiple sclerosis, spinal cord injury, central poststroke pain, polyneuropathy, complex regional pain syndrome, and trigeminal neuralgia.35 Other anticonvulsants include valproic acid, sodium valproate, and topiramate. Although several small-scale, randomized controlled trials have evaluated their efficacy in the treatment of neuropathic pain, the evidence regarding their routine clinical use as adjuvant analgesics has been equivocal.36

Table 2. First-Tier Adjuvants for Neuropathic Pain Medication

Daily Dose Range

Major Side Effects

Duloxetine

30–120 mg

Nausea

Gabapentin

100–3,600 mg

Sedation, dizziness, peripheral edema

Pregabalin

150-600 mg

Sedation, dizziness, peripheral edema

Nortriptyline 25-150 mg

Sedation, dry mouth, blurred vision, weight gain, urinary retention

Venlafaxine

37.5–225 mg

Nausea

Lidocaine patch, 5%

1-3 patches daily for a maximum of 12 h

Local erythema, rash

MUSCLE RELAXANTS Skeletal muscle relaxants encompasses several medications with multiple modes of action. Cyclobenzaprine is widely used for the treatment of musculoskeletal disorders. It also has been reported to be effective in the treatment of fibromyalgia.38 Animal studies have suggested that cyclobenzaprine activates the locus ceruleus in the brain stem, increases release of norepinephrine in the ventral horn of the spinal cord, and inhibits α-motor neurons.39 The drug is structurally related to TCAs and has a similar AE profile. Concomitant use with tramadol may precipitate seizures, and caution should be used when prescribing cyclobenzaprine to patients with arrhythmias, congestive heart failure, hyperthyroidism, and during the acute recovery phase following a myocardial infarction.40 Tizanidine is a centrally acting skeletal muscle relaxant. An α2-receptor agonist, tizanidine inhibits the release of excitatory amino acids from spinal interneurons. It is chemically related to clonidine but has significantly less antihypertensive effect. 41 A 2008 review reported that tizanidine was helpful not only for patients with spasticity from spinal cord injury, traumatic brain injury, and multiple sclerosis but also for those with chronic low back and neck pain associated with myofascia.42 Tizanidine should be used with caution in patients with impaired renal function, as clearance is decreased by 50% when creatinine clearance falls below 25 mL per minute.43 Baclofen is a GABA analog that acts on GABAB receptors, which are abundant throughout the central nervous system.44 Baclofen reduces hyperreflexia, a feature of phasic spasticity, but typically is less beneficial in patients with supraspinal spasticity.45 A 1994 study showed the drug to be more effective for muscle relaxation than diazepam.46 It is FDA-approved to be given intrathecally in patients with severe spasticity

Adapted from reference 55.

who cannot tolerate oral medications. Rapid withdrawal of baclofen may precipitate a life-threatening reaction and rebound phenomenon, and it therefore must be tapered slowly.

TOPICAL AGENTS Lidocaine 5% patch (Lidoderm, Endo Pharmaceuticals) is FDA-approved for the treatment of PHN. Lidocaine gel reduces ectopic activity in the voltage-gated sodium channels of damaged sensory nerves.47 The patch also acts as a mechanical barrier that may relieve allodynia in some patients. Because of its delivery system, systemic side effects are rare. The most common adverse reaction is local skin irritation. Additional, unapproved uses include the treatment of painful diabetic peripheral polyneuropathy and low back pain.48 Capsaicin, which is derived from chili peppers, stimulates transient receptor potential vanilloid receptors and subsequently depletes substance P from sensory nerve fibers.49 A meta-analysis of the effectiveness of capsaicin in patients with painful diabetic polyneuropathy demonstrated a benefit of the compound over placebo. Common side effects include local skin irritation and burning.50 The FDA has approved a high-concentration 8% capsaicin patch (Qutenza, NeurogesX) for the treatment of PHN.51 Diclofenac is an NSAID that is available in a 1% gel (Voltaren, Endo Pharmaceuticals and Novartis) and a 1.3% patch (Flector, Pfizer). A recent study reviewed the safety and efficacy of diclofenac 1% gel in patients with knee osteoarthritis and found statistically significant improvement in several measures of pain and function.52 The most common AE was mild local dermatitis.

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Topically applied single or multiagent analgesics compounded by specialty pharmacies also are available. A 2002 email study that surveyed 120 clinicians revealed that 27% (n=32) reported using compounded topical agents as part of their practice. These clinicians perceived that 43% (±4%) of treated patients responded favorably to the topical agents, with an average of 47% (±3%) reporting pain relief and few AEs.53 A recent case study showed that a combination topical cream consisting of isosorbide dinitrate 0.4%, capsaicin 0.075%, and lidocaine 3% was effective in decreasing pain in a diabetic patient with painful neuropathy unresponsive to oral pregabalin and topical capsaicin.54

Conclusion Adjuvant analgesics offer an alternative approach to the monomodal use of opioids for pain and have been noted to be especially useful in treating patients with neuropathic pain55 (Table 2). They may serve as either primary or synergistic agents. As part of a multimodal approach to the treatment of pain, they offer many potential advantages. Clinicians who incorporate these drugs into their practice may help patients increase activity levels, decrease their dependence on opioid monomodal therapy, experience enhanced analgesia, and enjoy an increased quality of life.

References 1.

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11. Leese PT, Hubbard RC, Karim A, Isakson PC, Yu SS, Geis GS. Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: a randomized, controlled trial. J Clin Pharmacol. 2000;40(2):124-132.

12. Sindrup SH, Otto M, Finnerup NB, Jensen TS. Basic Clin Pharmacol Toxicol. 2005;96(6):399-409.

13. Shelton RC. Classification of antidepressants and their clinical implications. Primary Care Companion. J Clin Psychiatry.

2003;5(suppl 7):27–32.

14. Saarto T, Wiffen PJ. Antidepressants for neuropathic pain.

Cochrane Database Syst Rev. 2007;17;(4):CD005454.

15. Rosenzweig T, Thomas T. An update on fibromyalgia syndrome: a multimodal therapeutic approach. Am J Lifestyle Med. 2009;3:226.

16. Atkinson JH, Patel SM, Meyer JM, Slater MA, Zisook S, Capparelli E. Is there a therapeutic window for antidepressants with analgesic response? Curr Pain Headache Rep. 2009;13(2):93-99.

17. Kong V, Irwin M. Adjuvant analgesics in neuropathic pain. Eur J Anaesthesiol. 2009;26(2):96-100.

18. Han HC, Lee DH, Chung JM. Characteristics of ectopic discharges in a rat neuropathic pain model. Pain. 2000;84(2-3):253–261.

19. McGeeney B. Adjuvant agents in cancer pain. Clin J Pain. 2008;24 (suppl 10):S14-S20.

20. Rice AS, Maton S; Postherpetic Neuralgia Study Group. Gabapentin in postherpetic neuralgia: a randomized, double blind, placebo controlled study. Pain. 2001;94(2):215-224.

21. Neurontin [package insert]. New York, NY: Pfizer; 2007.

22. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Neurology. 2006;67(10):1792-1800.

23. Caraceni A, Zecca E, Bonezzi C, et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol. 2004;22(14):2909-2917.

2. Wallenstein DJ, Portenoy RK. Nonopioid and adjuvant analgesics.

In: Berger AM, Portenoy RK, Weissman DE, eds. Principles and Practice of Palliative Care and Supportive Oncology. New York: Lippincott Williams & Wilkins; 2002:435-455.

24. McEvoy GK, Snow EK, Miller J, et al., eds. AHFS 2008 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2008.

3. Knotkova H, Pappagallo M. Adjuvant analgesics. Anesthesiol Clin.

2007;25(4):775-786.

25. Brungon LL, Lazo JS, Parker KL, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001.

4. Buvanendran A, Lipman A. Nonsteroidal Anti-inflammatory Drugs and Acetaminophen. In: Bonica’s Management of Pain. 4th ed.

Philadelphia, PA: Lippincott Williams & Wilkins; 2010:1157-1171.

26. McQuay H, Carroll D, Jadad AR, Wiffen P, Moore A. Anticonvulsant drugs for management of pain: a systematic review. BMJ. 1995; 311(7012):1047-1052.

5. Singh G, Fort JG, Goldstein JL, et al. Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I study.

Am J Med. 2006;119:(3)255-266.

27. Ichikawa K, Koyama N, Kiguchi S, Kojima M, Yokota T. Inhibitory effect of oxacarbamazepine on high-frequency firing in peripheral nerve fibers. Eur J Pharmacol. 2001;420(2-3):119-122.

6. Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Nonsteroidal anti-inflammatory drugs for low back pain. Cochrane Database Syst Rev. 2008;(1):CD000396.

28. Gomez-Arguelles J, Dorado R, Sepulveda J et. al. Oxcarbazepine monotherapy in carbamazepine-unresponsive trigeminal neuralgia.

J Clin Neurosci. 2008;15(5):516-519.

7. Fleischmann R, Iqbal I, Slobodin G. Meloxicam. Expert Opin Pharmacother. 2002;3(10):1501-1512.

29. Dogra S, Beydoun S, Mazzola J, Hopwood M, Wan Y. Oxcarbazepine in painful diabetic neuropathy: a randomized, placebo-controlled study. Eur J Pain. 2005;9(5):543-554.

8. McDaid C, Maund E, Rice S, Wright K, Jenkins B, Woolacott N. Paracetamol and selective and non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) for the reduction of morphinerelated side effects after major surgery: a systematic review. Health Technol Assess. 2010;14(17):1-153.

9. White PF, Tang J, Wender RH, et al. The effects of oral ibuprofen and celecoxib in preventing pain, improving recovery outcomes and patient satisfaction after ambulatory surgery. Anesth Analg.

2011;112(2):323-329.

10. Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009;22(5): 588-593.

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30. Yaari Y, Devon M. Phenytoin suppresses ectopic discharge in rat sciatic nerve neuromas. Neurosci Lett. 1985;58(1):117-122.

31. Wiffen PJ, Collins S, McQuay HJ, Carroll D, Jadad A, Moore RA. Anticonvulsant drugs for acute and chronic pain. Cochrane Database Syst Rev. 2010;(1):CD001133. WITHDRAWN. 32. Dilantin [package insert]. New York, NY: Pfizer; 2006 33. Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens EL. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain. 1997; 73(2):223-230.

34. McNamara J. Drugs acting on the central nervous system.

In: Harman G, Limbird LE, Morinoff PB, et al, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill; 1996:461-486.

35. Eisenberg E, Shifrin A, Krivoy N. Lamotrigine for neuropathic pain.

Expert Rev Neurother. 2005;5(6):729-735.

36. Zin CS, Nissen LM, Smith MT, O’Callaghan JP, Moore BJ. An update on the pharmacological management of post-herpetic neuralgia and painful diabetic neuropathy. CNS Drugs. 2008;22(5):417-442.

37. Elenbaas JK. Centrally acting oral skeletal muscle relaxants. Am J Hosp Pharm. 1980;37(10):1313-1323.

38. Chou R, Peterson K. Drug Class Review: Skeletal Muscle Relaxants: Final Report [Internet]. Portland, OR: Oregon Health & Science University; 2005.

39. Commissiong JW, Karoum F, Reiffenstein RJ, Neff NH. Cyclobenzaprine: a possible mechanism of action for its muscle relaxant effect. Can J Physiol Pharmacol. 1981;59(1):37-44.

40. Flexeril [package insert]. Fort Washington, PA: McNeil Consumer & Specialty Pharmaceuticals; 2003.

41. Coward DM. Tizanidine: neuropharmacology and mechanism of action. Neurology. 1994;44(11 suppl 9):S6-S10.

42. Malanga G, Reiter RD, Garay E. Update on tizanidine for muscle spasticity and emerging indications. Expert Opin Pharmacother.

2008;9(12):2209-2215.

43. Zanaflex [package insert]. Hawthorne, NY: Acorda Therapeutics; 2008

46. Waldman HJ. Centrally acting skeletal muscle relaxants and associated drugs. J Pain Symptom Manage. 1994;9(7):434-441.

47. Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996;65(1):39-44.

48. Argoff C. Conclusions: chronic pain studies of lidocaine 5% using the neuropathic pain scale. Curr Med Res Opin. 2004;20(suppl 2): S29-S31.

49. Caterina MJ, Schumacher MA, Tominaga M, Rosen TA, Levine JD, Julius D. The capsaicin receptor: a heat-activated ion channel in the pain pathway. Nature. 1997;389(6653):816-824.

50. Zhang WY, Li Wan Po A. The effectiveness of topically applied capsaicin. A meta-analysis. Eur J Clin Pharmacol. 1994;46(6): 517-522.

51. Wallace M, Pappagallo M. Qutenza: a capsaicin 8% patch for the management of postherpetic neuralgia. Expert Rev Neurother. 2011; 11(1):15-27.

52. Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials.

Drugs Aging. 2011;28(1):27-40.

53. Ness T, Jones L, Smith H. Use of compounded topical analgesicsresults of an internet survey. Reg Anesth Pain Med. 2002;27(3): 309-312.

44. Price GW, Wilkin GP, Turnbull MJ, Bowery NG. Are baclofensensitive GABAB receptors present on primary afferent terminals of the spinal cord? Nature. 1984;307(5946):71-74.

54. Kopsky DJ, Keppel Hesselink JM. A new combination cream for the treatment of severe neuropathic pain. J Pain Symptom Manage.

2010;39(2):e9-e10.

45. Saltuari L, Kronenberg M, Marosi M, et al. Long-term intrathecal baclofen treatment in supraspinal spasticity. Acta Neurol (Napoli) 1992;14(3):195–207.

55. Dworkin R, O’Connor A, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain.

2007;132(3):237-251.

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PO L ICY & M A N A GE ME N T

ClipChart U Nashville, Tenn.: Vanderbilt University Medical Center is the third U.S. hospital to offer nitrous oxide to women during childbirth to manage pain. The odorless and tasteless gas is blended with oxygen and selfadministered by women in labor through a mask. The hospital says the practice is safe for the mother and child because the mixture is expelled through the lungs rather than the liver. The gas begins working within one minute of inhalation and will leave the system within five minutes of discontinuation.

sing a novel brain imaging system Dr. Pollard’s group presented its called functional electrical imped- findings at the 2011 Euroanaesthesia ance tomography by evoked response meeting, in Amsterdam. (fEITER), Brian Pollard, MD, of the University of Manchester, England, and 3 colleagues showed that general anesthestics appear to induce a gradual dimming of consciousness. The researchers said the results support the notion that anesthesia prevents cells in the brain’s cortex from communicating effectively.

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San Diego, Calif.: Anesthesiologists at UC San Diego have received a $3.2 million grant from the National Institutes of Health to help make surgery less stressful for children. Zeev Kain, MD, and colleagues will implement the “P-TIPS” program in four California hospitals, training surgical staff and anesthesiologists to use positive behaviors to ease anxiety and pain in their pediatric patients.

Methods can include anything from humor to simple medical terminology. A second NIH grant will be used to create an Internet site that will help parents ease children’s anxiety. Web-based Tailored Intervention Preparation for Surgery (WebTIPS) will provide extensive details on surgical procedures and postoperative care. It is designed to allow parents to better understand complex operations and help with a child’s recovery.

Collier, Fla.: Women in this Gulf Coast county can expect to live a86 years, longer than those from anywhere else in the United States, according to a new report from the Institute for Health Metrics and Evaluation at the University of Washington. That’s the good news.

The bad news: When it comes to life expectancy, the nation as a whole, and women in particular, lost ground against other nations in the past decade. In 2007, the last year of data for the report, life expectancies for American men and women were 75.6 and 80.8 years, respectively. That was good enough for 37th place each on the world ranking. (The report is available at http://www. pophealthmetrics.com.)

Your Brain on Anesthesia

MHAUS Offers Writing Award

he Malignant Hyperthermia Association of the United States (MHAUS) is pleased to announce the availability of an award of $1,500 to the author of a manuscript related to malignant hyperthermia.

Malignant hyperthermia (MH) is an inherited disorder of muscle that is triggered by commonly used anesthetic agents and may lead to death or disability. The condition can occur at any time during anesthetic use.

In order to promote awareness and study of MH and its various manifestations, George Massik, a founding member of MHAUS, has graciously offered to support the writers’ award. The Daniel Massik Fund at The Foundation for Jewish Philanthropies in Buffalo, N.Y., was established by Mr. Massik in memory of his son, D ­ aniel, who died from MH. This award will provide a stipend of $1,500 to an anesthesia resident or fellow, or an anesthesiologist who is within five years of finishing his or her training, to attend the annual meeting of the American Society of Anesthesiologists or, in special circumstances, another meeting of comparable merit.

Award Details • The award will be given to the primary author of the manuscript on MH judged most outstanding. The

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•

•

• •

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format may be a case report, literature review or original study.

The document should address a significant issue related to the problem of MH. Candidates must currently be a res­ident or fellow in anesthesiology or an anesthesiologist who is within five years of ending his or her training.

The paper must be a minimum of three typed double-spaced pages and a maximum of 10 pages, and the author’s CV should be included.

The paper must not be in any stage of publication.

The deadline for receipt of the manuscript in the MHAUS office is Aug. 1, 2011.

The award will be presented in October at the annual MHAUS ­Recognition Reception at the 2011 annual meeting of the American Society of Anesthesiologists, in Chicago.

The winner will be notified by Aug. 31, 2011, to allow for coordination of travel plans.

For more information, contact the Malignant Hyperthermia Association of the United States (MHAUS), ATTN Gloria Artist, by regular mail at P.O. Box 1069, Sherburne, N.Y. 13460; fax at (607) 674-7910; or email at gloria@mhaus.org.

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P OLI C Y & M A NAGE MENT

Fair Market Valuation: the Death Spiral of Physician Compensation

W

e hear the word “fair” a lot these days. We’re asked to pay our “fair” share of taxes.

We’re asked to bear our “fair” share of the sacrifice. Not to go too Ayn Rand on you, but it’s painfully obvious that those demanding your “fair” share also are demanding the right to determine what’s fair.

If you are on board with this concept so far, you probably aren’t surprised by the epidemic of “fair” infecting the permitted parameters of agreements between physicians and hospitals. Of course, I’m talking about “fair” in the context of fair market value, one of the key factors in a number of compliance concerns—from federal and state antikickback laws, to Stark and state law prohibitions on so-called self-referral, to the limits of deals entered into by notfor-profit hospitals and health systems.

And you also probably won’t be shocked to learn that, in reality, the fair market valuation process often is

the

of

hardly fair, is blind to value and generally ignores the true market. In a sense, it’s simply Orwellian doublespeak. Well, that’s not exactly true; it has a tremendously real impact on physician compensation, and that impact is negative.

The Hospital–Valuation Consultant Complex You’re likely familiar with the term military–industrial complex, used to portray the cozy relationship among politicians, defense contractors and the armed forces. It describes the fact that the defense industry and its players give political contributions to politicians who then endorse defense spending, which results in purchases by the armed forces from the defense industry.

Thanks to the expanded scope of compliance laws turning on the issue of fair market value and the increasing trend of hospital–physician transactions—such as hospital acquisition of physician practices, hospital

perfect balance

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not to mention the other values that are found in the fourth quartile, the highest quartile. Those fourth quartile values cannot simply be employment of physicians, assumed to be outside the coverage agreements and realm of actual fair market the push toward so-called Mark F. Weiss, JD value. Yet valuation consulhospital–physician aligntants ignore the existence of ment such as accountable care orga- that top quartile, which must exist in nizations—the relationship between order to determine the 75th percentile hospitals and health systems, the large maximum as to which they will opine. purchasers of valuation services and the To recap: large valuation consulting firms selling • The hospital gives the consultant those services has tightened. Hospitals money for the valuation opinion. and their executives rely on valuation • The consultant gives the hospital opinions to avoid being prosecuted for protection in the form of a valuation violating the law and are willing to pay opinion as to fair market value.

• The consultant gives the hospital the for those defensive opinions.

Consultants desire the substantial benefit of a valuation that ignores fees they charge hospitals for the rote everything above the 75th percentile number crunching they perform. In (in other words, it relieves the hospia very real sense, they do understand tal of the burden of paying anything value—at least with respect to their above an arbitrary cap). services—in that they take relatively The Compensation small amounts of labor and sell it for Death Spiral the value it truly represents: the value of safety for their clients.

As if the present impact of artifiBut at the same time, they are overly cially capping the market were not bad careful to cover their behinds in terms enough, let’s look at its effect as that of an improper valuation opinion. process continues to play out over time.

This leads to nonsensical ceilings on We’ll start with a physician who’s opined value in order to build so much negotiating with Community Hospital safety into the opinion that it becomes something other than a true valuation It’s painfully obvious of your services.

Here’s the kicker: Hospitals and that those demanding their administrators are happy to receive the by-product—a valuation your ‘fair’ share also are that fits well below the full amount of the compensation or support that they demanding the right to would otherwise have to pay if the market were truly analyzed. It’s uncerdetermine what’s fair. tain whether hospitals actively encourI once thought that if age this level of “safety” or whether they are merely happy to receive its this continues unabated, benefits; either way, it creates a false ceiling that ignores fairness, value and physicians would be the actual market.

The 75th Percentile This overcautiousness causes valuation consultants to often state that they never opine as to the bona fides of a deal at more than the 75th percentile of value as reported on national, or large-area regional (eg, “Western”) studies. Of course, some valuation consulting firms conduct their own studies and sell that information to those same hospital clients.

Think about this for a minute: In order for the 75th percentile to exist, there must be a top value,

working for a bag of peanuts. Then I realized it’s more likely to be for three-fourths of a bag.

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PO L ICY & M A N A GE ME N T or its medical foundation over the amount of compensation under a new employment relationship in connection with the purchase of her practice by the hospital.

Setting aside all of the strategic issues with respect to maximizing compensation, the valuation consultants engaged by Community Hospital opine that the 75th percentile of compensation for the physician’s specialty, gleaned from averaging national compensation surveys, is $X. The consultants are adamant that they won’t opine as to a value greater than the 75th percentile. Community Hospital agrees to pay physician compensation at the 75th percentile as the fair market value of her services in connection with the 2011 employment contract.

During 2011, these valuation consultants and their competitors are all referencing the same national compensation surveys, and they’re all pointing to somewhere near $X as the 75th percentile (the maximum per-physician compensation with the medical specialty that they will bless in their valuation opinions).

By the time our physician and the hospital are negotiating the renewal of her employment contract in 2014, because of the prevalence of deals in effect from 2011 to 2014 at the $X maximum, the national compensation surveys relied on

by Community Hospital’s valuation consultants now indicate that $X-$Y dollars is the new 75th percentile. In other words, because of the prevalence of valuation opinions at $X three years prior, $X is now at the top of the range in the fourth quartile and can no longer be justified in terms of the protection that valuation consultants seek in issuing their opinions. In its place comes the new 75th percentile, $X-$Y. Of course, flash forward another two or three years and the 75th percentile is now well below $X-$Y. And the cycle starts all over again, and again, and again.

I once thought that if this continued unabated, physicians would eventually be working for a bag of peanuts. But then I realized that if valuation opinions are still essential at that point in time, it’s likelier to be for three-fourths of a bag.

What You Must Do If you’d like to create a better future for yourself with respect to “fair” physician compensation, there are steps that you must begin to take at the micro— that is, personal or group—level.

To begin, you need to understand and appreciate that a strategy in connection

with compensation can’t be separated from your strategy with respect to the entire contractual relationship with a hospital. And if you are negotiating on behalf of a group, that contracting strategy must be consistent with your group’s overall business strategy.

As is the case with respect to any strategic issue of this complexity, it takes considerable time and effort to deploy the required tactics. This includes significant research as to the definition of the relevant market, the

development of supporting data, the complete understanding of the valuation process and a complete understanding of the ways—and ways not—to present data in response to a valuation request if one is made.

Of course, on a national level, the hospital–valuation consultant complex deserves intense scrutiny. I am in the process of gathering information from readers like you regarding experiences with artificial caps on valuations for the purpose of a follow-up article. I would

Under the microscope.1 Echogenic pattern under coating helps reduce impact on feel.

NG I M N COSOO

appreciate your assistance; please see the contact information below.

—Mark F. Weiss, JD Mark F. Weiss is an attorney who specializes in the business and legal issues affecting anesthesia and other physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at the University of Southern California’s Keck School of Medicine and practices with the Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, CA, representing clients across the country. He can be reached by email at markweiss@advisorylawgroup.com.

Under ultrasound.2 Echogenic pattern produces clear, crisp image with reduced artifacts and acoustic shadowing.

Stimuplex® Ultra. Echogenicity without Compromise.

Improved visibility without negatively impacting tactile feel and acoustic needle shadowing.

Same tactile feedback, needle feel and overall handling as B. Braun’s clinically-proven3 Stimuplex A needle.

Reduced acoustic shadowing and artifacts under the needle may facilitate safer needle advancement during Supraclavicular and Popliteal nerve blocks.

30 degree, short bevel. Most experts agree that short bevel needles (30-45°) carry less risk of causing nerve injuries during PNB than sharp needles with longer beveled tips.4

See the Stimuplex Ultra video!

Scan the QR code or go to http://bit.ly/stimuplexultra 1. Microscope image at 25x from Uni of Hanover, Stimuplex Ultra 22G. 2. Stimuplex Ultra 22G, animal model, 45 degrees.

3. A. Sardesai, N. Denny., M. Herrick, A. Lynch, A. W. HarropGriffiths, “A study of the characteristics of single-injection insulated block needles in a biologic model.”

RAPM Vol. 29 No. 5, (Sept- Oct, 2004.)

4. Admir Hadzic, Peripheral Nerve Blocks: Principles and practices. 2004. The McGraw-Hill Companies Inc.

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P OLI C Y & M A NAGE MENT

Hospital Charges Surge for Treating Severe Sepsis, But Reasons Unclear

H

ealth care costs associated with severe sepsis appear to have increased considerably over the past decade, according to a recent study.

Not only does severe sepsis increase a patient’s risk for morbidity and mortality, it places considerable demand on health care resources, said Rahul Nanchal, MD, assistant professor of medicine and neurology, and director of the Medical Intensive Care Unit at Medical College of Wisconsin, in Milwaukee, who helped conduct the study. Health care–associated infections affect an estimated 1.7 million hospitalizations each year, yet the economic costs attributable to these infections are poorly understood.

“Reliable estimates of these costs are needed to efficiently target limited resources and improve clinical and financial outcome for patients and health care facilities,” Dr. Nanchal said.

Major improvements in the management and outcomes of severe sepsis have occurred over the past decade, Dr. Nanchal said. “However, we hypothesized that the costs associated with the condition have significantly increased.”

Large Sample Size In order to test this theory, Dr. Nanchal and his team used the Nationwide Inpatient Sample database from 2000 to 2008 to examine the mortality, total charges, hospital length of stay (LOS) and dispositions of patients admitted with diagnosis of severe sepsis—defined as systemic inflammatory response syndrome in response to an infection associated with at least one organ failure.

“This sample of hospitalizations is considerably larger than those used in previous studies, and it captures a greater diversity of hospitals and geographic locations,” said Dr. Nanchal, who presented his findings at the Society of Critical Care Medicine’s 2011 annual meeting (abstract 564).

A total of 5,247,400 estimated hospital admissions were identified with severe sepsis over the study period. Diagnostic codes in adults aged 18 and above were used to identify severe sepsis. Mortality associated with the condition fell over time, from 37.5% in 2000 to 26.5% in 2008. But home discharges also decreased by a similar proportion—from 36.4% in

2000 to 27.1% in 2008. “More people were surviving, but survivors were being released into long-term care facilities or required home health care, which are both expensive propositions,” Dr. Nanchal explained.

In addition, hospital LOS decreased from 16.1 days in 2000 to 14.1 days in 2008. However, total daily charges increased from $4,370 to $6,430 over the same period. Total charges attributable to severe sepsis were $20,000 (adjusting for inflation) more in 2008 than in 2000—$90,648 versus $70,336 respectively, the researchers said.

How can the jump be explained? “Every hospital increases its charges by 2% to 3% annually, but even if we take into account a 5% annual price hike, our calculations still indicate that costs associated with sepsis are increasing,” Dr. Nanchal said.

Another possible reason for elevated costs would be an increase in attendant charges during that time period, said Steven Simpson, MD, a sepsis expert and associate professor of medicine at the University of Kansas Hospital, in Kansas City. The costs of antibiotics used to combat resistant organisms—which are becoming increasingly common in cases of severe sepsis—also may be higher than traditional antibiotics, he said.

The only FDA-approved drug for severe sepsis is drotrecogin alfa (Xigris, Eli Lilly), which has been dogged by controversy for its high price tag. A fourday course of treatment with Xigris costs roughly $8,000. The FDA approved Xigris in November 2001, so presumably the latest study would have been able to account for its presence on the market.

The most effective way to reduce costs is prevention and early recognition, Dr. Simpson suggested.

“Approximately 40% of severe sepsis develops in hospitalized patients, which is why our hospital and many others are ‘chasing zero,’ that is, attempting to eliminate severe sepsis that is caused by insertion of catheters, failure to wash hands, inappropriate handling of urinary catheters,” he said. “Severe sepsis

very well may be treatable with simple measures such as antibiotics and fluids, if—and it’s a big if— it is detected early and critical tissue hypoxia has not developed,” he explained. Once shock is present, sepsis becomes very expensive to treat.

The primary limitation of this study was its retrospective nature, Dr. Nanchal said. “Because we’re not using prospective data there is no way of knowing whether there were coding errors, which may have led to the inaccurate classification of severe sepsis.”

Dr. Simpson noted that the number of cases of severe sepsis identified in the study over the study span was lower than that predicted by any of the epidemiologic studies. Estimates were 750,000 cases per year in 1995, with a 1.5% increase per year. “What this suggests to me is that severe sepsis is underdiagnosed in the nation,” he said.

Dr. Simpson also pointed out that the new study generated information regarding hospital charges, not costs. “I happen to know that my hospital’s costs of caring for a severe sepsis patient have gone down over the past four years, along with LOS and mortality,” he said. Yet costs may not necessarily be reflected in charges, which may change for numerous reasons related to keeping hospitals afloat, he said.

However, it would be difficult to repeat the study looking for hospital costs, rather than charges, because each hospital would need to report costaccounting data. “So, that cannot be considered something remediable,” he said.

—Michelle Grey Campion

One-Year MILD Data Show Safety, Efficacy of Minimally Invasive Procedure National Harbor, Md.—A minimally invasive interventional pain procedure for the treatment of lumbar spinal stenosis has shown statistically significant efficacy and a strong safety profile at one year, according to the results of a new prospective, multicenter study.

The MILD surgical procedure reduces the degree of central canal stenosis by removing ligament and small amounts of lamina using a fluoroscopically guided, percutaneously placed

cannula. The procedure is performed under local anesthesia with moderate sedation. According to the investigators, led by Timothy Deer, MD, of the Center for Pain Relief, in Charleston, W.Va., the dearth of data at one year for spine procedures speaks to the importance of the new study.

The trial’s results included data for 170 procedures performed in the first phase of the MILD trial (n=58), completed last year. Improved outcomes

in the current study included a significant reduction in pain (defined as 40%) in 79% of patients, as measured by score change on the visual analog scale (a mean score of 4.5 from a baseline score of 7.4); significant improvements in function, as measured by score change on the Oswestry Disability Index, in 71% of patients (a decrease from a mean score of 48.6 to 36.7); clinically significant improvements for pain and function on the Zuhrich Claudication

Questionnaire; and statistically significant improvements in patient satisfaction as measured by score change on the 12-Item Short Form survey.

No serious adverse events related to the device or the procedure were reported.

The study results were presented at the recent annual meeting of the American Academy of Pain Medicine (abstract 286).

—AN Staff

FASTEST GROWING IV SEDATIVE1

Different situations require different sedative solutions The first and only alpha2 agonist indicated for sedation2,3 Nonintubated patients prior to and during surgical and other procedures.2 Initially intubated and mechanically ventilated patients during treatment in an intensive care setting.2 Administer Precedex® by continuous infusion not to exceed 24 hours.2

Important Precedex Safety Information Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.

Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events.

Learn more at www.Precedex.com A right fit for today’s sedation management practices Please see the brief summary of Prescribing Information on adjacent page.

References: 1. Based on increases in weight of active ingredient sold (either mcg or mg). IMS Health National Sales Perspective 2Q 2009. US nonretail market, all channels injectables. 2. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2008. 3. Kamibayashi T, Maze M. Clinical uses of α2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349.

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-2637/R1, Mar., 11. Printed in the USA.

For more information on Advancing WellnessTM, contact your Hospira representative at 1-877-9HOSPIRA (1-877-946-7747) or visit www.hospira.com.

Reference EN-2680

Precedex®

(dexmedetomidine hydrochloride) injection

For Intravenous Use Rx only

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

1 1.1

INDICATIONS AND USAGE Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.

Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.

1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex.

5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.

Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene.

The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required.

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.

In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex.

5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex.

Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.

5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) Precedex subjects experienced at least 1 event 24 to 48 hours after end of

study drug. The most common events were nausea, vomiting, and agitation.

Tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated.

Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)].

5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)].

6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth.

Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)].

Table 2: Adverse Reactions With an Incidence >2%— Intensive Care Unit Sedation Population <24 hours*

Adverse Event Hypotension Hypertension Nausea Bradycardia Atrial fibrillation Pyrexia Dry mouth Vomiting Hypovolemia Atelectasis Pleural effusion Agitation Tachycardia Anemia Hyperthermia Chills Hyperglycemia Hypoxia Post-procedural hemorrhage Pulmonary edema Hypocalcemia Acidosis Urine output decreased Sinus tachycardia Ventricular tachycardia Wheezing Edema peripheral

All Randomized Precedex Precedex Placebo Propofol (N = 1007) (N = 798) (N = 400) (N = 188) (%) (%) (%) (%) 25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2%

24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2%

12% 19% 9% 3% 3% 4% 1% 5% 2% 3% 1% 3% 4% 2% 3% 3% 2% 2%

13% 4% 11% 0 7% 4% 1% 3% 5% 6% 6% 1% 1% 2% 0 2% 3% 3%

2% 1% 1% 1%

2% 1% 1% 1%

3% 1% 0 1%

4% 3% 2% 2%

1% 1%

1% 1%

0 1%

2% 2%

<1% <1% <1%

1% 1% 0

1% 0 1%

5% 2% 2%

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 patients received Precedex for less than 24 hours. The most frequently observed treatmentemergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3).

Table 3: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event

Randomized Dexmedetomidine (N = 387)

Placebo (N = 379)

28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2%

13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2% 2% 2% 1% <1% <1%

Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain Hyperglycemia Acidosis Pleural Effusion Oliguria Thirst

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5.

Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study* Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Dexmedetomidine (N=244)

Midazolam (N=122)

56%

56%

28% 42%

27% 19%

5% 28% 25%

1% 42% 44%

10% 12% 11%

10% 15% 15%

19% 9% 7% 7% 7% 6% 5% 5% 2%

30% 13% 2% 6% 2% 6% 6% 3% 1%

2% 2% 1%

1% 6% 7%

† Includes any type of hypertension.

1 Hypotension was defined in absolute terms as Systolic blood

pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value.

2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value.

3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value.

4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Table 5. Number (%) of subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group Precedex mcg/kg/hr Adverse Event

≤ 0.7* N = 95

> 0.7 to ≤ 1.1* N = 78

> 1.1* N = 71

6% 5% 5% 3% 2% 2%

5% 8% 5% 5% 4% 6%

14% 14% 9% 7% 9% 10%

1%

3%

9%

Constipation Agitation Anxiety Oedema peripheral Atrial fibrillation Respiratory failure Acute Respiratory Distress Syndrome

*Average maintenance dose over the entire study drug administration

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies.

Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event Hypotension1 Respiratory depression2 Bradycardia3 Hypertension4 Tachycardia5 Nausea Dry mouth Hypoxia6 Bradypnea

Precedex N = 318 (%)

Placebo N = 113 (%)

54% 37% 14% 13% 5% 3% 3% 2% 2%

30% 32% 4% 24% 17% 2% 1% 3% 4%

1

Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or Diastolic blood pressure of <50 mmHg.

2

Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 beats per minute or > 25% decrease from baseline.

3

Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value.

4

Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg.

5

Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value.

6

Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

Postmarketing Experience The following adverse reactions have been identified during post approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

Table 7: Adverse Reactions Experienced During Post-approval Use of Precedex Body System

Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors

Cardiovascular Disorders, General

Blood pressure fluctuation, heart disorder, hypertension, hypotension, myocardial infarction

Central and Peripheral Nervous System Disorders

Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia

Liver and Biliary System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase

Metabolic and Acidosis, respiratory acidosis, Nutritional Disorders hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

10

OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.

Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

6.2

Manufactured and Distributed by: Hospira, Inc. Lake Forest, IL 60045 USA Licensed from: Orion Corporation Espoo, Finland Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

32 I AnesthesiologyNews.com

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TE C H NO L OGY

Inside the Used Equipment Market Have you ever considered buying a piece of used anesthesia equipment?

Anesthesiology News recently spoke with Phil Jacobus, founder of DOTmed.com, an auction site for used medical equipment, about what to look for— and look out for—in this market.

AN: Why should an anesthesiology department or group practice consider buying a piece of used equipment?

I’m actually frequently asked if I’m aware of specific instances where a piece of equipment has, as the result of being used or having been refurbished, caused harm to a patient and I have never heard of PJ: The main reason to buy used is fundamental— such an instance. That does not mean that it has not buyers want to save money—but there are other rea- happened, but suggests that it is not an inherent or sons, such as availability. There might be a waiting prevalent problem. list to receive new equipment and used equipment is simply more readily available and makes more AN: From a buyer’s perspective, what sense to acquire. In other instances, buyers acquire a used anesthesia machine just to get the parts that anesthesia equipment makes the most can keep their current equipment up and running. sense to consider buying used?

This also might be done because a group of clinicians know a particular machine and are accustomed PJ: It makes most sense to buy the equipment you to using it. They might not wish to train for a new already have trained on because there is no downmachine, but instead keep what they have in top con- time or learning curve. This also would mean that dition to extend its life. Having spare parts can be an you probably have spare parts and your biomedical important part of that. I know of some anesthesiol- engineers already know how to service it. Everyone ogy departments that have bought used machines to knows about a doctor who interned at a U.S. hospital bridge between today and next year when they buy and learned how to use a specific anesthesia machine. all new machines. Having parts on demand also can We often get calls from anesthesiologists around the decrease downtime; anesthesiology and biomedical world exploring various equipment options, and engineering departments like to have spare parts for we always advise them to buy the machine they are this reason as well. In addition, hospitals with a large familiar with. It makes it easier to know how to use it research section should think about going with used and that is a big plus. equipment, including anesthesia machines and monitors. This will make their funds stretch much farther. AN: From a seller’s perspective, what

Phil Jacobus

Obviously, newer equipment is more valuable but in some cases, older equipment is in higher demand because it is easier to use and less software-driven.

In short, there is a buyer for almost everything in different places in the world. Dräger is a wellknown brand; so is Ohmeda, which became DatexOhmeda and today is part of GE Healthcare. These anesthesia machines that are more than 20 years old sell. Machines with more vaporizers and ventilators will sell for more money than if they are missing the vaporizers and ventilators. In Europe, Engström was a well-known name in this category. It also is easier to sell a machine that is in service than it is to sell a machine that has been taken out of service.

AN: What about manufacturer support?

If a department or group buys a piece of used equipment, can it expect the same level of service as if it had been a new device?

PJ: In terms of manufacturer support, in some cases the manufacturer will refuse to service the machine that it did not sell. In other cases, the manufacturer will service the machine without a problem and sometimes will charge a fee to evaluate the machine to make sure that it qualifies for service. devices are easiest to move?

Fortunately, in the United States, supply and AN: Has any study found a risk to patients PJ: If you are selling an anesthesia machine, never demand has created an environment where there from used equipment? assume that what you have is unsaleable. Most peo- are third-party service companies for anesthesia PJ: To my knowledge, there is no study that dem- ple believe that newer equipment is more saleable machines so even if the original equipment manufaconstrates that used equipment is a risk to patients. than older equipment but that is not necessarily true. turer refuses support, you can go to a third party for service.

W

hat did you read last month? A look at the significant words that appeared most frequently in the June 2011 edition of Anesthesiology News.

AN: How does a buyer go about inspecting a used machine? What warranties are available?

PJ: Like buying anything that is an investment, it’s important for careful due diligence, and that means having someone qualified inspect and test the equipment. Some are qualified to do it themselves, but in most cases it’s better to have a qualified engineer instead. It is worth spending extra money to have the machine evaluated and in most cases cost-justified, especially if the equipment is in the tens of thousands of dollars. It’s certainly worth spending $1,000 to $1,200—which is a typical inspection cost—to have the machine inspected, otherwise your entire investment could be at risk. Many companies that sell anesthesia machines sell them with warranties and we estimate that approximately 40% of service on these machines is performed in-house. Purchasing a used anesthesia machine is not for everyone, but it has its place.

■

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AnesthesiologyNews.com I 33

TECH N O L OGY

Video Aids Intubation for Airlifted Patients Simulation study suggests greater success, but no gain in speed

T

he use of video laryngoscopy during air transport of trauma or medical patients may increase the rate of successful intubation by nearly 20%, new data show.

But surprisingly, researchers found that video laryngoscopy did not shorten the total time required for intubation, as they had expected. The investigators presented their results at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 471).

“Traditional visualization makes it difficult to obtain a view of the vocal cords, but once you do, it’s easy to intubate the trachea,” said Allan P. Klock Jr., MD, professor of anesthesia and critical care at the University of Chicago Pritzker School of Medicine, who was not involved in the study.

“The opposite is true for video-assisted laryngoscopy.”

Dr. Klock noted that directly visualizing the larynx requires physicians to establish a straight line of sight, but they can do so using a video laryngoscope while maintaining the natural curves of the trachea.

In the new study, Bob Cambridge, DO, an emergency medicine resident at OSF St. Francis Medical Center, in Peoria, Ill., and a colleague enrolled 30 emergency medicine residents, critical care registered nurses and paramedics with varying levels of airway management training to conduct endotracheal intubation on a mannequin in a civilian helicopter.

Thirteen participants directly visualized the larynx while 17 used a video laryngoscope (GlideScope, Verathon Medical). All participants made two intubation attempts—one in a medical scenario and the other in a trauma scenario, in which the mannequin’s neck mobility was constrained using a cervical collar. Study participants sat in the forward-facing seat with the mannequin’s head against the rear bulkhead of the helicopter. The two groups had similar levels of training.

The researchers found that 97% of the attempts (33 of 34) to intubate using video laryngoscopy were successful, compared with 81% (21 of 26) of those in which clinicians relied on direct vision (P=0.037).

Clinicians who used the video laryngoscope obtained an optimal view of the mannequin’s larynx in just under nine seconds (mean), compared with

18.5 seconds for those who directly visualized the anatomy. That difference was not statistically significant (P=0.19).

Time to completed intubation was roughly equivalent for each group, at 25.87 seconds for video laryngoscopy and 25.64 seconds for

direct visualization, according to the researchers.

“We think the time elapsed between larynx visualization and tube placement will decrease as people gain more experience using the video-assisted laryngoscope,” Dr. Cambridge told Anesthesiology News.

Both Drs. Cambridge and Klock said the cost of a video laryngoscope is a common barrier to outfitting a helicopter with the device, but they argued that added expense is negligible compared with the total cost of a helicopter.

—David Wild

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Significant pain relief*1 • OFIRMEV 1 g + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2

Reduced opioid consumption*1 • OFIRMEV 1 g + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated

Indication OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever.

Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.

Do not exceed the maximum recommended daily dose of acetaminophen.

Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.

OFIRMEV should be administered only as a 15-minute intravenous infusion.

Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.

The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.

The antipyretic effects of OFIRMEV may mask fever in patients treated for post-surgical pain.

Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

*Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery.

Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology.

2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.

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TE C H NO L OGY

Each Member of BCMA Team Is Responsible for Safety Louisville, Ky.—The most important factor in implementing a successful bar code medication administration (BCMA) program is ensuring that all players in the process feel that they are accountable to one another.

Moreover, that sense of shared responsibility can’t only be present in the rank-and-file staff tasked with implementing BCMA. “It has to be

present all the way up to the top at the executive level,” said Karla M. Miller, PharmD, BCPP, director of pharmacy at the Hospital Corporation of America (HCA), in Nashville, Tenn.

For BCMA to work, a multidisciplinary team that works well together is essential, Dr. Miller said at the 2011 unSummit for Bedside Barcoding meeting. All members must feel a sense of

responsibility not only for the successes but the failures in improving patient safety in their hospitals, she stressed.

A lack of accountability can have a very negative impact on the work the team is trying to do, and also on the morale of team members.

“Often you have resentment among team members for various reasons.

Some have different work ethics, or

different ways of approaching things, or just different standards of performance,” Dr. Miller noted. “Also, when you have a team without accountability, you just get average work and you begin to accept that mediocrity.”

Teams that lack accountability miss deadlines and place undue pressure on those team members who are willing to work hard to implement patient safety, she added.

Barriers to Success After BCMA was instituted in the HCA consortium of hospitals, Dr. Miller and her colleagues began to ask questions to identify some of the barriers that were preventing the program from developing and moving forward. They found that team members were blaming each other, rather than taking responsibility for the success of the project as a whole.

“Some told us it was pharmacy’s fault, some blamed the biomed people, some blamed the information technology staff. There were a lot of excuses and it was a prime example of people not being held accountable and just finger pointing,” she said.

But the multidisciplinary team began to work more cohesively after potential problems were identified. Also, specific responsibilities for each team member were elucidated.

As these measures evolved and were adopted, team members began to feel comfortable with one another.

“They felt comfortable questioning each other’s approach. They weren’t afraid of being wrong. Respect was established and everyone was held to the same standards. We made it possible for poor performers to feel pressure to improve, but in a respectful way,” Dr. Miller said.

Steps To Creating More Accountability Jon Lakamp, PharmD, vice president of pharmacy at Sisters of Mercy Health System, in St. Louis, and a co-presenter at the unSummit session, detailed more thoroughly how accountability can be established. He listed responsibilities for some of the key players on the BCMA team. As members became more accountable for their actions, compliance with bar-code scanning rose. At Sisters of Mercy hospitals, compliance was less than 90% when BCMA was first instituted. Two years later it was 95% and continues to rise, he said.

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TE CHNOLOGY

The first key player is the top executive.

“The executive leader’s role involves setting expectations,” Dr. Lakamp said. “It’s all about assuring that the automation is sound and actually works, and communicating those expectations to the clinicians who are involved in direct patient care as well as to the staff who oversee the delivery of that care.”

Next on the team is the medication safety leader, who can be a pharmacist, nurse or someone in charge of quality.

“The medication safety leader’s role is all about defining best practices, outlining the exact process that is to be followed based on the safest methodologies documented in the literature, knowing what medications require independent double-checking, how to document that this checking has been done,” Dr. Lakamp said. “It’s establishing all policies and procedures behind utilizing the technology and putting the patient in the center of the process.”

The middle manager has several important responsibilities. Perhaps the most important is being able to recognize and respond to health care staff who may be knowingly or unknowingly putting patients at risk. “If there are at-risk behaviors, the middle manager has to be able to appropriately respond. He or she may have to do some coaching or counseling and be prepared to take action in cases of reckless behavior, consistent with a ‘just culture,’” Dr. Lakamp said.

The pharmacy department needs to confirm that all medications are available on a unit-dose basis, that the bar codes work and that verification processes are in place.

Information technology needs to ensure that all equipment is running properly and reliably. “Some of the key roles for IT include making sure that back-end support systems are in place, that dictionaries are built, that bar codes are flowing into the right systems, and making sure that all systems are updated on a regular basis,” he said.

Last but definitely not least is the patient. “We need to empower patients so that they feel free to speak up if they see something that doesn’t look quite right to them,” Dr. Lakamp said.

“When we started a campaign to get our patients to hold our staff accountable, that was probably one of the most

powerful tools that we had. When the patient asked the nurse why she wasn’t scanning a medication when the last three nurses did so, that was more impactful than having the nurse’s supervisor do the counseling, so setting the stage for having our patients hold us accountable definitely is a very key tool.”

Dr. Lakamp emphasized that setting up a culture in which accountability is recognized as a key component is essential for success. “Make sure you’ve got the right systems in place, the right tools in place, and set the stage for the right path to follow, from the beginning. Make sure everyone on the team has performance goals and that they all feel accountable for implementing safe patient care.”

Setting the Stage Laura M. Lee, RN, special assistant to the deputy director for clinical care at the National Institutes of Health (NIH) Clinical Center in Bethesda, Md., agrees that accountability is important. “Setting the stage for assuring accountability starts at the leadership level of the organization,” she said.

Ms. Lee is responsible for ensuring that patients participating in one of the more than 1,400 clinical research protocols at the NIH Clinical Center receive not only the highest-quality, but also the safest care. She also is responsible for designing and operationalizing the organization’s patient safety activities, coordinating the clinical center’s clinical quality and performance measurement activities, directing the patient perception survey process and ensuring compliance with accrediting organizations.

“A first step toward creating a culture of accountability is to articulate clearly the strategic importance of an initiative such as bar coding,” Ms. Lee said. “Equally important is assuring that the organization provides appropriate support, such as staffing, equipment and supplies and training, to those staff members who are responsible for implementing and maintaining these types of complex, critical patient safety initiatives.”

—Fran Lowry Drs. Miller and Lakamp have disclosed that they have no relevant financial relationships.

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PRN

Damage Control Protocol Sharply Boosts Survival in Trauma Patients

A

three-part damage control resuscitation that combines high plasma and platelet ratios, permissive hypotension and limited crystalloids increases odds of 30-day survival by 250% in selected trauma patients, according to a study presented at the annual meeting of the American Surgical Association.

“To truly achieve the outcomes expected with damage control resuscitation, you need to apply all three tenets, not just the principle of higher plasma and platelet ratios,” said Bryan A. Cotton, MD, associate professor of surgery at the University of Texas Health Science Center, in Houston.

“And, for the ratios to work, you must be prepared to deliver them immediately on arrival.”

Dr. Cotton and colleagues retrospectively studied 390 patients who underwent damage control laparotomies over a six-year period. Of these, 108 patients were treated after January 2009 and received the three-part damage control resuscitation (DCR).

Before 2009, Dr. Cotton pointed out, only the higher plasma and platelet ratios were being practiced.

The three-part DCR technique is similar to that used by the military since

2005, but has never been studied in a civilian population.

Analysis showed that the patients in the DCR group were more likely to survive for 24 hours (97% vs. 88%; P=0.006) and 30 days (86% vs. 76%; P=0.03). DCR patients also had less evidence of the lethal triad, defined as acidosis (initial pH <7.3), hypothermia (temperature <95 F) and coagulopathy (international normalized ratio [INR] >1.5) on arrival in the ICU: 46% compared with 88% for the rest of the study cohort (P<0.001).

The patients who were treated by DCR had less need for crystalloids (median 14 vs. 5 L), red blood cells (13 vs. seven units), plasma (11 vs. eight units) and platelets (six vs. no units) in the first 24 hours (P<0.05), than the patients who did not receive DCR. “Needless to say, DCR was a very meaningful adjunct to DCL [damage control laparotomy] management,” said Donald Trunkey, MD, professor of surgery at Oregon Health & Science University in Portland.

In 2005, military clinicians developed DCR after noticing that severely injured patients had better odds of survival when they received whole blood– based resuscitation. Civilian trauma

centers soon began to adopt elements of DCR after multiple studies showed favorable outcomes associated with a 1-to-1-to-1 ratio for plasma, platelets and whole blood.

However, civilian hospitals and researchers have focused on the high ratio of plasma and platelets. Many centers have not adopted the other tenets of DCR, permissive hypotension and limited crystalloids.

The reported study was conducted at the Memorial Hermann Hospital in Houston, a level 1 trauma center that admits more than 5,000 trauma patients annually.

Trauma surgeons at the hospital have used higher plasma and platelet ratios in resuscitations for several years.

However, in January 2009, the faculty added the remaining components of DCR. One year later, investigators set out to determine if implementation of all three components translated into improved survival.

Of more than 25,000 trauma patients admitted between 2004 and August 2010, 390 underwent DCL techniques. All minors, prisoners, pregnant women, patients who received more than five minutes of cardiopulmonary resuscitation prior to the

Overdoses of Popular Painkiller Send Thousands to ER Each Year

operating room or who died there were excluded from the study.

After controlling for age, arrival base deficit, INR and blood pressure, DCR was independently associated with a 2.5-fold increased odds of 30-day survival (95% confidence interval, 1.105.58; P=0.028). DCR was the only factor that predicted 30-day survival, analysis showed.

Full details of the study will be published in an upcoming edition of Annals of Surgery.

Investigators caution that the study was limited to patients who underwent a DCL and did not include a broader group of trauma patients.

Dr. Cotton and colleagues currently use DCR for all trauma patients with suspected bleeding or who are at risk for significant bleeding.

A similar randomized trial is under way at Baylor University looking at permissive hypotension. Preliminary findings, published earlier this year in the Journal of Trauma, show that targeting resuscitation to a mean arterial pressure of 50 mm Hg results in reduced intraoperative red blood cell and plasma transfusions, less postoperative coagulopathy and higher 24-hour survival (J Trauma 2011;70:652-663).

“Their results will be very hard to ignore,” Dr. Cotton predicted.

—Christina Frangou

“Because these data are based on ED records, it is often difficult to determine exactly what motivated the patient—if they had a premeditated plan to end their life with an overdose or if the overdose was an impulsive act,” Daniel Budnitz, MD, medical offion–abuse-related overdoses of acetamin- of the overdose-related ED visits. The remaining cer at the Division of Healthcare Quality Promotion, ophen products have led to more than 16.7% of overdoses were attributed to accidental mis- said in a press release.

78,000 emergency department (ED) vis- use of over-the-counter products in order to achieve Taken correctly, acetaminophen is safe and effective, its per year, and the majority of these overdoses are greater pain relief. but the margin between a therapeutic and a dangerous intentional, according to a new study from the dose is smaller than many patients may realize. A Centers for Disease Control and Prevention (Am toxic dose depends on the person’s age, weight and J Prev Med 2011;40:585-592). liver function, but in general, people should not The study analyzed data from the National take more than 4 g of acetaminophen per day, and Electronic Injury Surveillance System from Jan. taking 7 g or more can lead to a severe overdose if 1, 2006, through Dec. 31, 2007, to estimate not treated (see article, page 39). People who take the number of annual ED visits that occurred acetaminophen continually should probably alternationwide for non–abuse-related acetaminonate with another pain medicine, like ibuprofen. phen overdoses. ED visits related to abuse of Individuals who have taken an overdose of acetaminophen products were not included in acetaminophen should call the National Poison the study.

Control Center (1-800-222-1222), follow their The study found three main causes for acetadvice and, if directed, go to the ED for an evalaminophen overdose among ED patients. Most uation. With prompt treatment, most patients overdoses (69.8%) were self-harm attempts, with fully recover. the highest rate occurring among patients aged 15 to 24 years. Unsupervised ingestion by chil—Based on a press release from dren younger than 6 years accounted for 13.4% Health Behavior News Service

N

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AnesthesiologyNews.com I 37

Pain M e d icine

Potential Links Found Between Opioid Prescribing Patterns and Abuse, Misuse

T

wo articles published in the April 6 issue of the Journal of the American Medical Association highlight potentially problematic prescribing patterns for opioids among younger patients and patients refilling prescriptions in the United States. The studies aimed to explain the increased use and abuse of opioids in recent years and make recommendations on how to resolve these complex issues.

In a research letter, the team of authors from the University of Pennsylvania and the National Institute on Drug Abuse reviewed data from the Vector One: National database from SDI Health (Plymouth Meeting, Pa.), that gathers prescription information from more than half of the retail pharmacies in the United States (JAMA 2011;305:1315-1321).

After analyzing the data, the researchers pointed to several possible contributors to the high rate of opioid analgesic abuse. Of all opioids prescribed, physicians wrote the most prescriptions (36.4 million, or 45.7%) for patients between ages 40 and 59 years and for those between 10 and 29 years (9.3 million, or 11.7%).

The researchers described the younger group as “the most likely to abuse drugs and develop addiction.”

More than half of the opioid prescriptions were dispensed to patients who had already filled another opioid prescription in the past month. Most of the prescriptions (84.9%) were for products containing hydrocodone and oxycodone, and were administered over short treatment courses (two to three weeks). During the past decade, the number of patients admitted to substance abuse programs for opioid addiction rose fivefold, the researchers noted.

While the authors acknowledged that opioids are among the most effective options for managing chronic pain, they noted that recent increases in opioid prescribing and related “increases in abuse and overdoses” underscore the need for pain physicians to understand the effects that current prescribing patterns have on patient health and the legal implications of these practices.

“Given the known side effects from inappropriate prescribing, use and storage, we can expect even worse public health and safety problems if physicians, pharmacists, patients and the government do not work together

to retain appropriate availability and reduce unwanted side effects,” said Thomas McLellan, PhD, one of the lead authors of the two articles and director of the Center for Substance Abuse Solutions in the Department of Psychiatry, at the University of Pennsylvania School of Medicine, in

Academy of Pain Medicine as well as implementing standardized screening procedures and special provisions for managing pain in patients at highest risk for abuse and dependence.

Philadelphia.

They also urged the pain community The second article, a commentary to agree on guidelines for the use of written by the same team of authors, nonpharmacologic options and the offered recommendations for “best administration of short- and long-actpractices” for prescribing opioids ing opioids while also establishing “rea(JAMA 2011;305:1346-1347). The sonable limits” on prescribed doses and authors called for the adoption of duration of therapy. see misuse page 42 guidelines developed by the American

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P A IN M ED I C I NE

Easing Chronic Pain Reverses Reduction of Gray Matter

P

eople who experience chronic low back pain also show reduced brain gray matter and impaired cognitive ability in parts of the brain associated with pain processing. Alleviating this pain, however, can reverse brain abnormalities and restore gray matter, according to a longitudinal study published in the Journal of Neuroscience (2011;31:7540-7550).

Previous studies have shown people suffering from chronic low back pain and other chronic pain conditions have reduced thickness in their left dorsolateral prefrontal cortex (DLPFC) and other brain regions. However, until now, none has indicated these regions increase in thickness with treatment.

To assess whether neuroanatomic abnormalities were reversible, the study

investigators recruited 18 individuals who had chronic low back pain for at least one year from an outpatient orthopedic spine clinic and a multidisciplinary pain center. They also enrolled 16 healthy, pain-free and sex- and agematched controls. left DLPFC, bilateral anterior insula/ At baseline, patients with chronic low frontal operculum and left middle/posback pain had a significantly thinner terior insula. cortex in several regions, including the The patients with chronic low back pain underwent spine surgery or facet joint injections; 14 patients and 10 controls were available six months later for follow-up testing.

At six months, 11 patients with chronic low back pain showed increased cortical thickness in the left DLPFC, whereas two of the three nonresponders had a decrease in cortical thickness in that region. Of the 14 patients, 11 also experienced a significant reduction in pain.

After treatment, researchers found increased cortical thickness was significantly associated with reduced pain intensity and decreasing physical disability. Abnormal brain activity observed during an initial attention-demanding cognitive task normalEven when she’s not saying a word, ized after treatment.

“The left DLPFC was the only region your patient is speaking volumes. that had a significant reversal of thickness loss, but other regions were trending toward reversal as well,” said lead author David Seminowicz, PhD, a researcher in Montreal, Canada, at the time of the study and now assistant professor in the Department of Neural & Pain Science at the University of Maryland Dental School, in Baltimore. “So, perhaps if we followed these patients for a year or two there would be full reversal of all the anatomic changes. The pain wouldn’t necessarily go away, but if their pain continued to decrease, we would likely see a full reversal.”

Robert Coghill, PhD, who was not involved in the study, agreed that these results could have significant repercussions for patients and clinicians. “The fact that [the DLPFC improvements] occurred over a relatively brief time frame suggests that it’s something much more reversible than neuronal loss,” said THE SENSING SYSTEMS OF COVIDIEN Dr. Coghill, associate professor of neuR E S P I R AT O RY F UN C T I ON + E N D -O R G A N P E R FU S IO N AND F UNCTI ON + HEM ODYNAM I C RESPONSE robiology and anatomy at Wake Forest School of Medicine, in Winston-Salem, N.C. “These thickness changes could serve as an objective biomarker for the FOR MORE INFORMATION, CALL presence or diminution of chronic pain, 1-855-SENSING which would be independent and hope(1-855-736-7464) fully support the patient’s subjective report.”

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AnesthesiologyNews.com I 39

Pain M e d icine

Better Labeling Could Reduce Acetaminophen Overdose

C

hicago researchers have found that patients purchasing overthe-counter pain relievers may not be fully aware of the active ingredients in these medications or the potential side effects associated with their use or misuse.

In six focus groups and personal interviews with 45 adult patients, researchers discovered that only 48% of patients said they examined product labeling of over-the-counter (OTC) drugs before purchasing or using them. The study results were published in the June issue of the American Journal of Preventive Medicine (2011;40:593-598).

“Patients in need of pain relief may not be concerned with taking a few more pills of [OTCs] than recommended as [they] may be viewed as relatively ‘safe,’” said Jennifer King, project leader for medication safety research in the Health Literacy and Learning Program at Northwestern University’s Feinberg School of Medicine, in Chicago, who led the study.

The study, funded by an unrestricted grant from McNeil Consumer Healthcare, maker of Tylenol, considered factors like patients’ knowledge of OTC pain relievers and their attention to product label information. The researchers focused their investigation on acetaminophen, the active ingredient in Tylenol and one of the most commonly used OTC pain medications in the United States.

Acetaminophen overdose is the leading cause of acute liver failure in the country, and misuse leads to more than 30,000 hospitalizations each year.

These adverse events typically result from patients exceeding the recommended maximum daily dosage or using multiple acetaminophen products (both prescription and OTC) simultaneously, Ms. King said.

Only 31% of the patients in the study recognized acetaminophen as the active ingredient in Tylenol. The research also pinpointed changes in product labeling that could potentially improve patients’ understanding of the products and their proper use. Most participants in the study said they found icons highlighting a product’s active ingredient and the maximum recommended daily dose of the product helpful.

“This study represents only the first step in the development of a uniform strategy for communicating active ingredients in [OTC] and prescription

products,” Ms. King said. “Our research team is evaluating whether the icons and messages proposed in this study are efficacious in attracting consumer attention to acetaminophen and improving understanding of the warnings associated with it.” Pain specialists are in a unique position to improve patients’ understanding of OTC pain relievers and the hazards associated

with using them, Ms. King said.

Mark J. Lema, MD, PhD, chair of anesthesiology at Roswell Park Cancer Institute, in Buffalo, N.Y., agreed with Ms. King’s assessment. “Marketing of Tylenol has led consumers to think that acetaminophen is a totally benign substance,” said Dr. Lema, who was not involved in the research. “But a massive Tylenol overdose can lead to acute

fulminant hepatic necrosis, resulting in death or the need for a liver transplant; daily use can double the risk of renal failure. With many prescription drugs becoming OTC agents, patients must become informed consumers and [consult with] their physicians to learn exactly what a side effect might be.”

—Brian P. Dunleavy

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P A IN M ED I C I NE

Closer Outcomes Tracking on the Horizon for Pain Clinicians

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xperts in the emerging field of care management are warning that an imminent and highly competitive “value-based” health care delivery model will require pain medicine clinicians to meticulously document patient outcomes and to demonstrate the monetary and clinical value of the care they provide. Increasingly, health care buyers are becoming concerned with cost savings while being equally insistent on the delivery of optimal health outcomes, and the onus will be on providers to demonstrate they are optimizing both.

A New Culture Ajay Wasan, MD, assistant professor in the departments of Anesthesiology, Perioperative and Pain Medicine, at the Harvard School of Medicine, in Boston, said that the inevitable change will improve the care patients receive and ensure pain medicine physicians and practices maintain a competitive edge.

“At the moment, there really isn’t a culture of care measurement in pain medicine,” noted Dr. Wasan, who is also co-chair of the American Academy of Pain Medicine’s (AAPM) Research Committee. “If a value-based care approach is widely adopted—and the idea has been gaining traction over the past few years—payers will increasingly demand to know how patients are doing in relation to specific treatments.

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improve with specific interventions.”

The value-based care approach, championed by Harvard Business School professor Michael Porter, is centered on the assumption that treatment outcomes, tracked and compared in a standardized and transparent manner across care providers, can improve both the efficiency and the quality of care (N Engl J Med doi: 10.1056/NEJMp1011024). Under this model, documented outcomes would serve as report cards, the grades of which would inform treatmentpurchasing decisions by individuals and groups.

Patients benefit because providers will compare their own outcomes with their competition and continually strive to refine their treatment and improve their clinical results, while maintaining efficiencies at all levels of care delivery. Rather than demonstrating reduced cost of care alone, the idea goes, physicians and care facilities would use the resulting outcomes data, along with figures on the cost of care at their particular facility or group practice, to demonstrate they are providing a high level of care per dollar spent. Outcomes are tracked not only over the course of a particular intervention, but for an extended period of time, proponents say, providing a fuller picture of health care outcomes.

In anticipation of the move to a value-based care model, Fred Davis, MD, assistant clinical professor at Michigan State University College of Human Medicine, in East Lansing, and co-founder and principal of ProCare Research in Grand Rapids, has developed the PRISM Patient Management System, an instrument specifically tailored to tracking outcomes in pain patients.

At the recent 2011 annual meeting of the AAPM, he explained the two components of PRISM. The first is a scoring system that gauges the overall disease severity of a patient’s pain problem. This section includes a checklist of physical and psychosocial characteristics common to various patient groups; this information is integrated into the collective PRISM database, which is compared with a patient’s treatment outcome against outcomes in the broader population of similar patients.

The second PRISM element is administered regularly throughout the course of treatment. It measures a patient’s daily and psychosocial functioning as well as general quality of life and treatment satisfaction.

All of the collected data is analyzed in real time and displayed or printed in a dashboard format for clinicians to reference at the point of care.

Dr. Davis said PRISM currently includes more than 30,000 sets of data for comparison and that the size of the database is growing as clinicians adopt the system. Like Dr. Wasan, he believes comprehensive patient tracking will represent a significant and welcome cultural change.

“Most patients are tracked anecdotally at present,” Dr. Davis said. “There might be some quantitative information collected, but gathering this type of data adequately in chronic pain patients in particular, is complicated. Our patients’ disease is multidimensional and what is measured in the clinic is typically limited.

“As physicians are increasingly graded under a

value-based model,” Dr. Davis said, “a tool to measure this multidimensionality will not only allow clinicians to measure outcomes but to do so in a way that accounts for more variable outcomes in those patients that are at a statistically increased disease risk because of the complexity of their illness.”

Michael Ashburn, MD, MPH, director of pain medicine and palliative care, at the University of Pennsylvania School of Medicine, in Philadelphia, who also spoke at the AAPM, said he and his colleagues have developed their own Internet-based outcomes data-collection system. Data are collected at the time of each visit, documented in the patient’s electronic health record, and made available immediately to help clinicians decide on the most appropriate treatment approach. Dr. Ashburn said the data also are used to improve the process of care for future patients.

Several Tools, but Adjustments Needed Outcomes tracking systems need to satisfy three parameters to be successfully integrated into a busy clinical practice, Dr. Ashburn said: 1. Outcome measures must be valid.

2. Results must be available quickly.

3. The cost of outcomes tracking should be minimal.

Most important, he said, there needs to be a clear payoff to using such a system.

“Physicians have to be convinced that the effort and cost is worth the data collected,” Dr. Ashburn said. “The data need to have value to the physician by allowing them to take better care of their patients.

The endeavor has to be seen as more than a research project, but rather as an important tool in our efforts to provide the best care for our patients.”

Dr. Ashburn and Dr. Davis’ systems are the latest additions to a growing number of similar tools, noted Dr. Wasan, pointing to the Chronic Pain Impact Network’s Patient Reports and the Pain Outcomes Evaluation Tool. He said all of these programs are helpful but still require tweaking.

“These systems are beneficial in that they take a chronic disease model approach, which accounts for the presence and the treatment of comorbidities in measuring outcomes, but they need to be less disruptive to workflow,” he said. “They also fail to measure treatment-specific outcomes in their bigger picture view. Ultimately, software-based systems will have to provide a view of treatment response from all angles.

Data will have to be collected at a level necessary to perform comparative effectiveness research.”

Tracking outcomes in the context of a value-based health care delivery model may sound like a competitive endeavor, but all of the stakeholders in the field of pain medicine stand to gain if data are shared between providers and with professional associations, Dr. Wasan said.

“Collectively, the hope is that we will be able to point to the aggregate data demonstrating that, as pain medicine practitioners, we are providing high-value, highquality care that makes a difference to our patients,” he said.

—David Wild

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Basics of Anesthesia with Evolve Website, Fifth Edition Robert K. Stoelting, MD; Ronald D. Miller

Widely acknowledged as the foremost introductory text, this latest edition provides the most authoritative and complete overview of anesthesia theory and practice and continues to serve as an excellent primer on the scope and practice of anesthesiology. The new edition is presented in full color and includes updated information on new and rapidly changing areas in anesthesia practice.

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Board Stiff Three: Preparation for Anesthesia Orals: Expert Consult—Online and Print

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Cardiac Anesthesia and Transesophageal Echocardiography

John Wasnick, Zak Hillel, David Kramer, Sanford Littwin, Alina Nicoara This book is a fast, efficient way for anesthesiology trainees to acquire the essential skills and knowledge necessary to successfully navigate the cardiac operating room. This unique guide imparts the basic principles of both cardiac anesthesia and echocardiography in a way that reflects the realities of clinical anesthesia practice.

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Comprehensive Textbook of Intraoperative Transesophageal Echocardiography

Robert M. Savage; Solomon Aronson This volume is the first comprehensive text on intraoperative transesophageal echocardiography. It features 1,000 full-color echocardiograms and covers every aspect of intraoperative TEE, from physics and “knobology,” to studies of cardiac valves and arteries, to the use of TEE in cardiac and noncardiac surgeries. The text focuses on uses of TEE in surgical decision making and includes specific clinical recommendations.

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For Doctors Only: A Guide to Working Less & Building More, Third Edition

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Handbook of C-Arm Fluoroscopy-Guided Spinal Injections

Linda Hong Wang, MD, PhD; Anne McKenzie-Brown, MD; Allen Hord, MD; Pain Consultants of Atlanta, Georgia C-arm–guided spinal injections have been performed widely for diagnostic and management of spine and para-spinal–related pain disorders.

This handbook illustrates spinal injections in an easy-to-follow, step-bystep fashion and presents fluoroscopy imaging and related spinal anatomy for medical professionals who may not have had formal training in radiography and related anatomy of the vertebral column.

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Medicine for Anaesthetists, Fourth Edition

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Practical Perioperative Transesophageal Echocardiography: Text with DVD-ROM

M.D. Vickers, MB, BS, FRCA, DA; Ian Power, MB, ChB, FRCA

In a new edition of this valuable and well-known anesthetic textbook, the editors have selected a new team of contributors who have given clear accounts of those medical and surgical conditions having a direct bearing on how the anesthetist chooses to manage the patient.

David Sidebotham; Alan P. Merry; Malcolm E. Leggett; Mary L. Edwards This practical guide will help improve your diagnosis and monitoring of perioperative cardiac patients. Reflecting five years of new research and clinical data in TEE, the book captures the latest developments in the field, and new chapters on epiaortic and 3D echocardiography, echocardiography in the ICU and echocardiography for adult congenital heart disease have been added. The videos on DVD demonstrate normal and pathologic findings in real time. The result is an outstanding tool for certification preparation and clinical practice.

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P A IN M ED I C I NE

Ultrasound-Guided Pump Refill Shows Promise for Improving Patient Safety

U

se of an ultrasound-guided intrathecal pump may improve drug delivery and prevent the complications often associated with this procedure, according to a new study.

Intrathecal drug delivery involves implanting a pump that can bring medication to a particular location. Although it may provide continuous and effective relief in patients with chronic pain, morbidity and even mortality may be associated with pump maintenance. Of particular concern is the “pocket fill,” which refers to misplacement of the needle during pump refill and may cause delivery of toxic doses of medication.

Officially, eight deaths and 270 serious or life-threatening injuries requiring medical intervention have been reported due to pocket fills; the real numbers may be higher.

“In my hospital, there were five admissions last year of patients who experienced complications related to pocket fills. All events happened at offices of

outside providers, and patients were rushed to the emergency department,” said study co-author Michael Gofeld, MD, assistant professor of anesthesiology, pain medicine and neurological surgery at the University of Washington (UW) School of Medicine, in Seattle, and clinical director of the UW Center for Pain Relief.

To determine the safety and efficacy of the real-time ultrasound-guided pump refill, Dr. Gofeld and colleagues performed a preclinical feasibility study, using unembalmed cadaver models with either an inverted or deeply implanted pump (Pain Med 2011;12:607-611).

“Our goal was to find safe and reliable access to the pump in a difficult situation where the pump cannot be palpated,” Dr. Gofeld said.

In the study, the team first tried to implant the pump in a cadaver with a heavy body frame, which is consistent with the typical clinical situation of a difficult pump refill. As expected, palpation

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of the pump was not possible. The researchers then attempted ultrasoundguided access using two needles to replicate reservoir and pocket fill conditions.

One operator performed the refills and another, the observer, assessed whether an inter- or intrapump fill had been done.

The researchers studied sonographic images of those conditions and developed an ultrasound-guided technique for accessing the pump injection port.

They found that clinicians who were inexperienced with ultrasound learned the procedure quickly, in about 30 minutes, and were able to distinguish reservoir from pocket fill after one or two 0.5-mL injections 100% of the time.

“When the injection is done inside the pump through the port, you see it as a color cone. When it’s done outside the pump into the pocket, you don’t see any consistent column spread—it’s kind of speckled,” Dr. Gofeld explained (Figures 1 and 2).

He noted that the feedback to his study has been “phenomenal,” adding that his team already has trained the physical medicine rehabilitation nurses to use the new technique.

“Several colleagues say that this technique should be accepted as a standard of care for difficult cases,” he said. “We don’t have any decent imaging alternatives in clinics and offices for difficult patients.”

Timothy Deer, MD, president of the Center for Pain Relief, in Charleston, W.Va., agreed that the study findings are important for pain practitioners who

Misuse continued from page 37 The authors also recommended that pain practitioners develop guidelines for the proper use of urine screening, treatment agreements, patient contracts and state prescription drug monitoring programs (to “reduce doctor shopping”). Finally, they believe the pain community must agree to develop standardized criteria for refilling and/ or discontinuing opioid prescriptions.

According to Dr. McLellan, pain specialists and primary care physicians have had “constructive” solutions for managing the risk for abuse and misuse among chronic pain patients treated with opioids; however, he added, “for the most part” these procedures have not been implemented.

Charles E. Argoff, MD, who was not

Figure 1. Pump injection.

Figure 2. Pocket injection.

deal with pump refills. “This is a small study, but it gives us a good indication of improving safety,” he said. “The problem associated with filling into the pocket is rare, but when it does occur, it’s deadly.

That is why this study is very important to ensure safety in difficult patients.”

—Laura Tendler Dr. Gofeld has received equipment support from Philips and Medtronic to complete the study.

Dr. Deer is a consultant for St. Jude Medical, Codman, Azur and Medtronic.

involved in the research, said that it is too soon to determine whether or not guidelines and protocols developed in recent years by professional associations and state medical boards to monitor the use of controlled substances when treating chronic pain have been implemented by a large number of prescribers. The pain community is well aware of the problems spotlighted in the JAMA articles and is committed to developing solutions, added Dr. Argoff, professor of neurology and director of Albany Medical Center’s pain management program, in Albany, N.Y. “Of course, all prescribers need to prescribe any medication—and for that matter, any treatment—as safely and rationally as possible,” Dr. Argoff said.

—Brian P. Dunleavy

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A D L IB

19th-Century Ether Entertainment Hans Christian Andersen, James Young Simpson and a memorable dinner party

“W

e met at the home of Dr. Simpson,” wrote a famous European author in his memoirs in 1855, “and in the large circle which was gathered there, several experiments were made with breathing in ether. I thought it distasteful, especially to see ladies in this dreamy intoxication; they laughed with open, lifeless eyes; there was something unpleasant about it, and I said so, recognizing at the same time that it was a wonderful and blessed invention to use in painful operations, but not to play with ...”

And so Hans Christian Andersen (1805-1875) expressed his displeasure at the inhalation entertainments that took place in Edinburgh, Scotland, in August 1847, at the instigation of Dr. James Young Simpson (1811-1870). Andersen was a frequent traveler and his host for this visit to Scotland was Carl Joachim Hambro, whose wife Caroline was a patient of Dr. Simpson.

Andersen published his first story in 1822, and 13 years later began publishing the fairy tales that made him famous. The trip to Great Britain in 1847 began in June, when he first met with Charles Dickens; on another visit a decade later, he spent several weeks at Dickens’ home.

At the time when Andersen and Simpson met,

Dr. Simpson was 15 years into the medical career which would make him one of the best-known physicians in Europe by the time he died. Weeks after the first ether anesthetic was administered in London in December 1846, Dr. Simpson tried it in a patient for whom labor was complicated by a pelvic deformity.

His success in that case made him a great advocate of anesthesia, and he and some colleagues began a quest for an agent without the problems of ether.

Their experiments with various substances became well known in Edinburgh. Finally, on Nov. 4, they tried chloroform. Four days later, Dr. Simpson used the agent in an obstetric case and his fame was assured. Yet chloroform anesthesia was only one of his many innovations. Dr. Simpson also advocated acupressure to control hemorrhage and worked on the problem of hospital infections, in addition to devoting much energy to archeological, literary and historical research and writing.

Andersen and Dr. Simpson may have met at a dinner on the night of Aug. 16, given by Mr. Hambro in honor of the Danish author. The next day Dr. Simpson gave his Andersen a tour of Edinburgh and invited several medical and literary types to attend a dinner at his own house. In his invitation to Dr. John Moir, Dr. Simpson wrote

about Andersen, “You will find him a most lovable being and a true child of nature.”

Attending both dinners was Catherine Crowe, an English novelist and playwright.

Andersen noted in his memH. C. Andersen oirs that Mrs. Crowe presented him with a copy of her novel, Susan Hopley (1841), at Dr. Simpson’s dinner and that “Mrs. Crowe and another poet drank ether.

I had the feeling of being among two insane who laughed with open eyes ...”

We can only wonder what Hans Christian Andersen’s reaction would have been if he had attended the many “frolics” with other substances that Dr. Simpson and his associates conducted in 1847 between Aug. 17 and Nov. 4.

—A.J. Wright, MLS Mr. Wright is a librarian in the Anesthesiology Department at the University of Alabama, in Birmingham.

Further Reading Secher O. Hans Andersen and James Young Simpson. Br J Anaesth.

1972;44:1212-1216.

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C OMM E NT A RY Young doctors trained in the

Here’s Looking at You, Kid

current generation live comfortably

“Just a gaze. An inspecting gaze, a gaze which each individual under its weight will end by interiorization to the point that he is his own overseer, each individual thus exercising this surveillance over and against himself. A superb formula: power exercised continuously, and for minimal cost.”

—Michel Foucault, The Eye of Power

I

n 1777, Jeremy Bentham, the founder of the utilitarian school of philosophy, described the panopticon, at that time a modern concept of constructing a circular prison so that the jailor in the center core tower was able to observe the activity of the prisoners in the surrounding cells without being seen. “Such observation allowed a small number to exercise control over large numbers of individuals … lunatic, convict, patient or schoolboy” because the prisoner, not knowing when or if he was being observed, controlled and censored his own behavior and effectively became his own jailor.

Visionary architects began to incorporate the panopticon in designs of prisons, hospitals and asylums, and the system can be seen in contemporary hospital wards, intensive care units and labor and delivery suites.

Two centuries after Bentham, the French poststructural philosopher Michel Foucault described the relationship between people as a constant struggle for power and dominance. Everyday concepts of right and wrong, true and false were mere illusions structured to allow the subjugation of individuals and groups by those in control of the “meta-narrative.”

This viewpoint politicized Foucault and led him to fight for the rights of minorities, and homosexuals in particular.

Foucault’s study of hospital architecture led him to Bentham’s device and the conclusion that the panopticon, more than brick and mortar, was a symbol of the structural relationship between the doctor and the patient as it had evolved since the Enlightenment.

Specifically, Foucault identified the “medical gaze”— the doctor’s observation of the patient, the history and physical, x-rays and lab tests that objectified the patient and separated body from selfhood.

under the All-Seeing Eye. The older ones complain, harrumph Steven S. Kron, MD

The mysterious way the doctor was able to discover and treat the masked underlying pathology endowed him with an almost magical status that could not be questioned or doubted. The patient’s acceptance of the medical gaze represented his acquiescence to the doctor–patient power relationship and allowed modern medicine to create a meta-narrative of the all-seeing, all-knowing doctor.

The 1963 French publication of Foucault’s Birth of the Clinic and the 1973 English edition coincided with the peak of what often is seen as medical paternalism. So much has happened since the days when doctors knew best. Dr. Kildare, Marcus Welby, M.D., and Ben Casey are gone. They’ve been recast with the self-doubting staff of “Grey’s Anatomy” and “House, M.D.,” who even the Addams Family wouldn’t want as personal physicians.

Like the periodic reversal of Earth’s magnetic poles from North to South, over the past 50 years, the medical gaze has turned on itself: The gazers have become the gazees. Everybody is watching us.

It began innocently enough. Medical insurers certainly had the right to know and understand what they were paying for. The Great Payer—the federal government—which began Medicare with the assurance that it would reimburse physicians and hospitals their usual and customary fees, soon had to backpedal from the unsustainable blank check it had written. Scores of auditors, coders and inspectors were hired to determine if doctors were cheating or providing “quality” care. Hospitals, in turn, hired similar legions for self-defense. Everyone was studying the books and the charts. It wasn’t long before the behavior of individual physicians began to be scrutinized.

Why did Dr. Jones’ patients do better or get out of the hospital sooner than Dr. Smith’s?

and die or move to Florida.

We learned that our errors caused the deaths of 100,000 people annually in the hospital alone. Certainly something needed to be done. Practice algorithms were created, followed by more practice algorithms. Give the antibiotic, check the glucose, raise the head, give that b-blocker! All good things— mostly. But as important as these steps are, it’s just as important to document that you have done them.

After all, you are being watched, and not just by the government but by the hospital, that also loses if you don’t follow the rules.

We learned how the airline industry, the standby metaphor for anesthesia, has improved safety by giving everyone from the pilot to the baggage handler a voice. Now the time-outs and pre- and postoperative briefings provide the opportunity for the whole surgical team to contribute. You’d better participate; you are being watched and will be reported if you snicker.

And then there are the questioning, Internet-educated patients, and naturally the lawyers. They are watching every move you make.

All of these developments have produced the inevitable. For the sake of survival, medical leadership is forced to go along. Young doctors trained in the current generation casually accept and internalize the paradigm of the reversed medical gaze. As the new prisoners of the panopticon, they live comfortably under the All-Seeing Eye. The older ones complain, harrumph and die or move to Florida.

Maybe this is all for the good. Only time will tell.

Yet whatever the outcome, Foucault’s vision of the nature of doctors and of the doctor–patient relationship is history. He would be proud.

Steven S. Kron, MD, is a semi-retired anesthesiologist and a frequent contributor to Anesthesiology News. He lives in Connecticut.

C ORRES P O NDE NCE To the Editor: ith reference to “Electronic Reminders Prompt Improved Ventilation Strategies” (May 2011, page 1) and many other articles, it has never been clear to me why we abandoned clearly identifying the various people involved in health care and now refer to them collectively as “providers.” This only leads the uninformed and confused public to believe that these individuals are somehow all equal in their knowledge and ability.

This term has been used more and more over the years and lumps fullfledged physicians with nurse anesthetists, optometrists, registered nurses,

W

operating room technicians and more, rather than clearly identifying to whom we are referring. We are doing this at our and our patients’ peril.

I realize that “inclusiveness” and “feel good” language is a part of our misguided political correctness. However, it is a calculated move by allied health workers to gain equal recognition and acceptance from a public that is being deliberately and increasingly misled. It has been one of the numerous ways to devalue the special training, knowledge and advanced capabilities of anesthesiologists and other medical specialists.

We seem puzzled by the increasing demands of the lesser-trained

individuals to be considered as equals, practice without supervision and expand their scope of practice by legislation or through their trade boards rather than through advanced education. This should not surprise us, since we unfortunately continue to use terms—providers, anesthesia care team, etc.—that intentionally obscure the boundaries between the medical profession and allied health workers and technicians.

It is not by accident that the boards for allied health workers increasingly encourage their various trade schools to bestow the title “Doctor” on their graduates: optometrists, chiropractors, podiatrists and now increasingly nurse

practitioners, physical therapists and legions of others who are following their example. This trend will only further confuse an already puzzled public.

I would strongly suggest that we stop using these ambiguous and unhelpful generic terms. Anesthesiology News bills itself as “The Independent Monthly Newspaper for Anesthesiologists.”

Please maintain your high professional level without diluting and downgrading our data with data involving allied health workers. Let them stand on their own merits and clearly identify themselves to the public.

—Stephen Ross, MD Fremont, Calif.

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Drover DR et al. Anesthesiology 2002, 97:82–89 White PF et al. Anesth Analg 2004, 99:1429-1435

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