Anesthesiology News - December 2010 - Digital Edition

Double conference issue: PostGraduate Assembly in Anesthesiology, New York School of Regional Anesthesia

McMahon Publishing

The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • D e c e m b e r 2 0 1 0 • Volume 36 Number 12

An Oximeter In Every OR WHO program pushes pulse ox in developing countries

New Hospital Risk Index May Reshape Quality Assessment

A

n an effort to make anesthesia safer for patients in the developing world, the World Health Organization is conducting a pilot project to study the use of pulse oximetry during surgery. The study, under way at two hospitals in the Republic of Moldova and the Republic of Zambia, will measure the effectiveness of pulse oximetry use and training by monitoring rates of hypoxemia during surgery.

novel risk stratification score based on more than 35 million hospital patient records may be an effective tool for predicting periprocedure mortality and length of stay.

Given the growing importance of administrative data for quality comparisons of hospitals, clinical departments and even individual physicians, some experts hailed the new index as a key step toward simplifying performance evaluations. However, others were less convinced of its usefulness, particularly for individual anesthesiologists.

Hospitals already are required to report major outcomes, including postoperative mortality, but valid comparisons between hospitals

see WHO page 49

see index page 30

I

INside

Life in a Fix: Confessions Of an Addicted Physician Editor’s note: Joel Freedland, DO, is a self-described physician addict. Dr. Freedland recently was released from a Michigan prison, where he served four years for defrauding Medicaid. Before serving his sentence, he spent 17 years as a fugitive, living in the Middle East, South America and elsewhere. The following article is the first in a three-part series written by Dr. Freedland about his experiences. Anesthesiology News is unable to verify most of the statements made in these articles, as they represent personal recollections with no supporting information beyond the author’s assertions.

08 | COMMENTARY Following the money: The decades-long struggle for status and power in anesthesiology.

I

n my more grandiose moments, I believe I am a juggernaut— one of the greatest forces of self-destruction ever let loose on Earth. There is something within me that rebels at the thought of ease, pleasure, self-acceptance. I have found myself in situations that most likely would have been rewarding with even the merest effort— yet I destroyed every vestige of credibility and trust. Sometimes I took the path of least resistance; at other times, implosion required an

20 | CLinical Anesthesiology Statistical model predicts patient pain during hospitalization.

27 | CLinical Anesthesiology Finding the perfect fit for pediatric LMAs.

35 | Pain Medicine Optimal analgesia for pain after hernia surgery.

extraordinary effort of will. Every turn down the tortuous path to Educationalreview ruin was taken. Rarely have I missed Echocardiography for the Anesthesiologist, an opportunity to reduce myself to see insert at page 26. penury, misery and the ashes of a potentially great life.

41 | CME—PreAnesthetic Assessment When the bombast and vanity are Lesson 289: PeriAnesthetic Management gone, however, the truth remains: Of the Ex-Premature Infant see juggernaut page 12

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4 I A n e s t h e s i o l o g y N e w s . c o m D e c e m b e r 2 0 1 0

Discuss these and other articles @ AnesthesiologyNews.com.

Heard Here First: The

great majority of anesthesia

groups will view mandatory compliance

necessary

programs as a

evil:

a cost. ... A much

smaller minority of group leaders December 2010

will understand that a compliance

The five most-viewed articles last month on AnesthesiologyNews.com

program can be used as a further lens

1. Anesthesia Journal Retracts Fluid Paper Over Ethics Concerns, Possible Fraud (Web Exclusive)

through which to

focus group

strategy in order to wring additional

2. Efforts Increase To Curb Rise of Illegitimate Pain Clinics in Florida 3. Computers Find New Ways To Muddle Prescriptions

profits from, and opportunity for, one’s

4. DEA: Propofol Headed for Controlled Substance Schedule

group.

5. The Pharmacology of Intravenous Anesthetic Induction Agents: A Primer (Educational Review)

Register for free @ AnesthesiologyNews.com to read these and other articles.

Alan Kaye, PhD, MD, New Orleans, LA Robert S. Lagasse, MD, New Haven, CT Alex Macario, MD, MBA, Stanford, CA The Independent monthly Newspaper for Anesthesiologists

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RUSSELL K. PORTENOY, MD, New York, NY J.G. REVES, MD, Charleston, SC

This should be your goal.

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C OR R E SP O NDENCE To the Editor: n his commentary, “The Taking” (see Anesthesiology News, October 2010, page 10), Dr. Cossman appears to make three points: 1) our current health care system is the envy of the civilized world; 2) the new health care law is a disaster; and 3) because government-run health care is the only alternative, we might as well crawl back in bed with the private health insurance industry.

To which I say: untrue, probably true and definitely misleading. In fact, although our current problems are much worse than Dr. Cossman suggests, available solutions are far more plentiful than he imagines.

Let’s start with worse: Dr. Cossman’s confidence that we enjoy the “finest health care system in the world” seems singularly ungrounded. He confuses free access to emergency rooms with free access to health care. He is correct that any citizen with heart failure can enter a hospital in pulmonary edema and leave with a free heart transplant. However, no citizen gets a free cardiac evaluation, blood chemistry test or medication to prevent heart failure in the first place. Any diabetic can receive a free amputation and wheelchair when a foot ulcer turns necrotic, but no one gets free glucose monitoring or insulin before necrosis begins. Any hypertensive suffering an acute stroke gets a free stay in the intensive care unit (no extra charge for the ventilator!), but no one gets free blood pressure checks or antihypertensive medications to prevent the stroke. You get the idea.

To be sure, researchers in the United States make brilliant contributions to medical knowledge. But we do a lousy job of applying them to care. Reliable statistics show that there are more than 20 other countries where a pregnant woman and her baby are more likely to survive the pregnancy; where the baby has a better chance of living to 1 year old; and where both have a better chance of surviving the next five years (see http://www.globalhealthfacts.org/bytopic.jsp and other sources). The United States ranks 47th in life expectancy; when adjusted for tobacco use, obesity, homicide, traffic accidents and our immigrant citizens, we look no better.

The United States is nearly alone in allowing illness to ruin families. Last year, medical crises bankrupted 2 million Americans, most of whom had health insurance when the illness began (Am J Med 2009;122:741-746). We also take lives needlessly: 44,000 Americans died of preventable causes in 2009 because they were too poor to afford basic health care (Am J Public Health 2009;99:2289-2295). This does not happen anywhere else in the industrialized world.

Although hundreds of wealthy foreigners fly first class to the United States to undergo elective operations at renowned hospitals, 1.2 million Americans left the country in 2009 to get essential health care unaffordable at home. That number is expected to exceed 6 million in 2010.

Now, for the alternatives. Clearly, many Americans cannot get the health care they need, even if the health care they need but can’t get might be the best in the world. And Americans pay twice as much for the health care they don’t get as other citizens pay for the health care they do get.

All this was true before the first draft of the Patient Protection and Affordable Care Act (PPACA) ever landed in Nancy Pelosi’s in-box.

I

What Dr. Cossman refers to as “wacky data” from the World Health Organization that reveals these inadequacies is corroborated by the Commonwealth Fund, the Kaiser Family Foundation, the Organisation for Economic Co-operation and Development and the CIA (OK, maybe the CIA guys qualify as “wacky”).

Dr. Cossman’s terror of the U.K.’s National Health Service has him metaphorically checking under his bed for government health care bureaucrats. Is the NHS so terrible? Our Veterans Administration, a near clone of the NHS, cares for our sickest patients with the best results at the lowest cost with the highest patient satisfaction in the country. Even Medicare does better than our for-profit private insurance companies. Whatever one thinks about government-run health care, it works pretty well.

But why ignore alternatives other than a government-run health system? The world (and the United States) provides a multitude of financing solutions, each of which provides universal access, better outcomes and lower cost. France uses employer-sponsored insurance coverage. Germany uses individually purchased insurance coverage. Taiwan uses a specific payroll premium dedicated exclusively to single-payer health care. And so on. Every other industrialized country has found its own way to better us.

Successful health care systems follow three rules: 1) Everyone is in a single risk pool with a single set of benefits. 2) There are no impediments to primary care. 3) No one profits from financing health care (you can profit providing health care, just not financing it). We are the only nation still attempting to finance health care with private insurance companies that fragment risk pools, deny primary care and profit from simply passing money to providers.

To the Editor: ongratulations to the NYSORA World Anesthesia Congress on its inaugural meeting (see Anesthesiology News, June 2010, page 38). However, there is no “void” of excellent international conferences for anesthesiologists.

Earlier this fall, more than 1,000 of us from around the world met in Beijing, China, for the 12th International Congress of Cardiothoracic and Vascular Anesthesia (ICCVA 2010). Attendees from 41 countries included more than 700 Chinese physicians, along with sizable delegations from Canada, Germany, Japan, New Zealand, South Korea, the United Kingdom and the United States.

Plenary sessions, workshops, panels and symposia were presented simultaneously in English and Chinese.

Among the more compelling topics was the growing awareness of the importance of proper cerebral oxygen perfusion during surgery (see Anesthesiology News, December 2009, page 1). Several leading experts in this area spoke at the conference, including Drs. John Murkin, Hilary Grocott and Mattias Heringlake.

I co-chaired a session with Prof. Yun Yue, chairman of anesthesiology at Chaoyang Hospital in Beijing, on advances in the management of aortic surgery.

Albert Cheung, MD, from the University of Pennsylvania, reviewed the latest strategies to protect the central nervous system and spinal cord during open thoracic and abdominal aortic aneurysms.

Many would agree that our much-abhorred PPACA is a soul-corroding abomination that enshrines everything repellent about our current arrangement: insurance companies selling cheap policies with great coverage to the young, healthy and employed but expensive policies with terrible coverage to the old, sick and jobless; “cost-sharing” policies that pay for neither primary care to keep people healthy nor the expensive complications causing bankruptcies; and the $200 billion cost to health care providers to collect their due from insurance companies.

Dr. Cossman is spot on when he notes American insurance companies celebrated this national legislation. After all, it compelled every American to buy their product regardless of price. The voices of protesting citizens were drowned out by the clinking of whiskey glasses in insurance board rooms around the country. If our Congress continues to attempt universal health care by forcing another 45 million Americans to purchase private policies, our health care expenditures will skyrocket and we will be no more healthy than we are now. Maybe less.

That Dr. Cossman says he is concerned, frightened and angry shows an appropriate appreciation for the problems PPACA poses to us as physicians, patients, taxpayers, heads of family and socially responsible citizens. Perhaps with less fondness for our private insurance industry and more understanding of the many working alternatives, his next essay will advocate one of the viable solutions.

—Samuel Metz, MD Dr. Metz is an anesthesiologist in Portland, Ore. He is a member of Physicians for a National Health Program, and a founding member of Mad As Hell Doctors.

C

Dr. Cheung’s Penn colleague, John Augoustides, MD, gave a very elegant presentation about advances in the replacement of transcatheter aortic valves, which was followed by a thorough discussion about the current state of the art in the anesthetic management of aortic aneurysms. We debated the central question: What is the end point for cooling prior to aortic arch replacement: temperature, jugular venous saturation, electroencephalogram, cerebral oximetry or readings on a bispectral index monitor? No conclusions this year— but those who are curious might want to attend the ICCVA 2012 (Nov. 14-17) in Auckland, New Zealand.

—George Silvay, MD, PhD, professor of anesthesiology, Mount Sinai School of Medicine, New York, N.Y.

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C OMM E NT A R Y

Pursuing Money, Buying Studies: The Beat Goes On

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or three decades I have witnessed a relentless campaign by nurse anesthetists for greater incomes from their employers—and, more recently, for a bigger share of the total professional anesthesia payments. Since the public has consistently valued the skills of highly educated physicians more than those of medically directed nurses, CRNAs have become frustrated.

The campaign now involves assertions of equivalence through sponsored studies, “doctor” degrees and improper promotions. I understand the pursuit of money, and have enjoyed the spectacle, but I worry increasingly about patient safety as this drama plays on.

How did we reach this point? The roots of the dispute date back to the 1980s, when Jerry Cromwell, PhD, began arguing that the costs of anesthesia delivery could be reduced if CRNAs provided more help to anesthesiologists. In a 1988 paper in Health Affairs (1988;7:118-131), Dr. Cromwell—a Harvard economist and founder of the Center for Healthcare Economics— wrote that “third-party payers should provide strong incentives for the appropriate delegation of anesthesia services using a team approach, that is, CRNAs medically directed by anesthesiologists.

Increased delegation results not only in substantial cost savings, but also in profound productivity increases.”

Dr. Cromwell cited annual nurse anesthetist incomes of $39,000 and anesthesiologist incomes of $145,000 in concluding costs would decrease as nurses helped. He cautioned, however, that “CRNAs do not work alone on the most complex of procedures, nor do they perform the most technical of tasks.”

These sentiments for increased use of nurses by anesthesiologists brought Dr. Cromwell to the attention of nurse anesthetists, when in 1989 they began to receive direct payments from Medicare. In an invited 1991 article in the Journal of the American Association of Nurse Anesthetists (AANA), Dr. Cromwell and co-authors described a technical advisory panel with three nurse anesthetists and two anesthesiologists that they convened for the Department of Health and Human Services.

“The U.S. faces a significant shortage of CRNAs, now and in the future … increasing the role of CRNAs in anesthesia care would result in significant savings to society.”

The authors acknowledged “with deep appreciation the assistance and

support of ” the AANA executive director. They had found a grateful sponsor, and it was then sweet music for nurses when in 1992, the center Dr. Cromwell founded recommended to the Physician Payment Review Commission, “(Medicare) payment should be split evenly (50/50) between the anesthesiologist and CRNA.” Despite other testimony that this would increase the

overall costs of anesthesia, equal payments for anesthesiologists and nurse anesthetists became Medicare policy.

Nurse anesthetist incomes rose steadily after Medicare adopted its equal payment policy, as has the total cost of anesthesia. Anesthesiologist incomes have increased proportionally less (2.3 vs. 3.9 times for CRNAs since 1988). The Medicare equal payment

policy has not convinced the public of equal worth. In a 1994 study of the anesthesia services market, published in the Robert E. Johnstone, MD Journal of Clinical Anesthesia,

D e c e m b e r 2 0 1 0

AnesthesiologyNews.com I 9

COMME N TA R Y I determined that purchasers would pay 55% more, on average, for anesthesiologists than for CRNAs, reflecting their valuations of anesthesiologist clinical skills and services. If repeated today, the findings would undoubtedly be similar, thanks to the roles of anesthesiologists as perioperative physicians, overall coordinators of care and quality improvement leaders.

The rising incomes of CRNAs have led predictably to a marked increase in nurses entering and graduating from

anesthesia programs, a number that has more than doubled over the past decade. So many nurses are graduating now that some are apparently having trouble finding positions. Thus it is not a surprise that this year the AANA funded another study by Dr. Cromwell’s group—nor that the study recommends more nurse anesthetists work without physician direction. Dr. Cromwell used Medicare billing data to show that CRNAs perform less difficult cases than anesthesiologists with

similar mortality rates. Of course, billing data are notoriously flawed and the data do not seem to support the conclusions anyway, especially because CRNA-only cases showed increases in mortality and complications after their states opted out from physician supervision requirements. But as Sonny and Cher sang: “Drums keep pounding a rhythm to the brain. La de da de de, la de da de da.”

In my state, the largest CRNA program recently added a year of business

courses and will graduate anesthetists with a “doctor” degree: Doctor of Management Practice in Nurse Anesthesia. I have always endorsed more education and training, but I wonder how much courses such as financial management for health care professionals will improve clinical performance.

Graduates should gain some extra clinical experience during their course time, but this is not a PhD or MD program.

Maybe extra education is not the point.

In another AANA-funded article published recently in Nursing Economics, the authors concluded that “anesthesiologists and CRNAs are interchangeable” and compensation for nurse anesthetists “lags behind anesthesiologists” (2010;28:159-169). In addition to the off-note conclusion, it’s a new and shrill salary reach.

It doesn’t need to be this way. I recently attended the 25th anniversary celebration of the Anesthesia Patient Safety Foundation, and sat next to leaders of the AANA and the American Association of Anesthesiologist Assistants. We all agreed that no patient should be harmed by their anesthetic, acknowledged that much work remains to be done and vowed that a culture of safety is our mutual goal. Divisive campaigns over status and incomes would seem to threaten this goal, while working together as productive anesthesia teams and departments can only help patient care. Cooperation is closer to the original AANA goal of improving anesthesiologist productivity, before greed overtook service and common sense. Sonny and Cher croon: “History has turned the page, uh huh. The beat goes on.”

—Robert E. Johnstone, MD Dr. Johnstone is professor of anesthesiology at West Virginia University, and vice president for professional affairs of the American Society of Anesthesiologists. This commentary represents his personal views.

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IN BRIEF

Going Down?

E

—AN Staff

A

nesthesiologists Marc Abreu, MD, David Silverman, MD, and colleagues at Yale University, in New Haven, Conn., have been studying a novel sleep detector that measures brain temperature with surface sensors. In the figures below, presented at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A1329), the researchers provide the first noninvasive documentation of changes in brain temperature changes sleep and awakening.

The responses at the “brain temperature tunnel”—which lies between the brain and the skin of the superomedial orbit—were distinct from those at the forehead and rectum.

—AN Staff 36.5

— BTT — FH

36 35.5 35 34.5 34

1730

1639

1548

1457

1366

1275

1184

1093

1002

911

820

729

638

547

456

365

274

33.5 183

diagnosed with the condition.

Only 18 (11%) had received treatment for the disorder, the researchers said.

“Undiagnosed obstructive sleep apnea may be associated with increased risk of complications in hospitalized patients,” the researchers said in a statement.

“Screening and evaluation for obstructive sleep apnea in high-risk patients should be considered as it may help reduce the burden” of the condition.

The researchers reported their findings at Chest 2010, the annual meeting of the American College of Chest Physicians.

The STOP-BANG questionnaire asks patients the following: 1. Do you Snore loudly?

2. Do you often feel Tired, fatigued or sleepy during daytime?

3. Has anyone Observed you stop breathing during your sleep?

4. Have you or are you being treated for high blood Pressure?

5. Is your Body mass index greater than 35 kg/m2?

6. Are you over 50 years of Age? 7. Is your Neck circumference greater than 40 cm?

8. Are you male [Gender]?

—Adam Marcus

Brain Temp Reflects Awareness

1

Most Patients Enter Hospital at High Risk for Sleep Apnea

ight in 10 hospital patients are at high risk for obstructive sleep apnea, according to a new study by Chicago researchers who say facilities should consider screening patients for the condition.

Researchers at Loyola University Health System used the STOP-BANG questionnaire to assess 195 patients at their institution. They found that 157 patients (80.5%) answered yes to at least three of the eight questions on the survey, putting them at high risk for sleep apnea.

Of the patients likely to have sleep apnea, 41 (26%) had undergone a sleep study and 31 (20%) had been

However, three of the patients who failed the assessment aspirated, despite having consumed no food or liquids by mouth.

Having a tracheostomy was the strongest predictor of which patients would fail the BSE, according to the researchers, who noted that tracheostomy is associated with a 20-fold greater risk for swallowing problems after a traumatic injury.

Some clinicians might be uncomfortable with the prospect of eschewing a barium test or endoscopic evaluation of swallowing for the BSE, Dr. Brown acknowledged. So far no head-to-head data exist to help compare the beside assessment with the other techniques. “However,” he added, “nobody cleared by our bedside swallow evaluation had a clinical aspiration event.”

Dr. Brown’s group reported its findings in a recent issue of the Journal of Critical Care.

To conduct the BSE, the examiner gently presses on the front of the patient’s throat as he or she tries to swallow. Failure to swallow within 10 seconds indicates a dysfunctional reflex. Patients who pass the first step then attempt to swallow an ice chip and a sip of water without coughing or choking. To pass the BSE, a patient must not fail any of the five steps.

At Dr. Brown’s hospital, clinicians administer the BSE three times over a 48-hour period. If a patient fails the third test, a barium study is ordered.

For their study, Dr. Brown and his colleagues administered the BSE to 291 trauma patients admitted to their hospital in 2008. Of those, 143 (49%) passed the exam and 148 failed. Those who failed the test spent significantly more time on mechanical ventilation than those who passed (14 vs. five days; P=0.001).

No patients who passed the BSE experienced a clinically evident aspiration event in the hospital.

92

brief, bedside examination for determining how well a patient can swallow could provide critical care physicians with a low-cost and effective alternative to conventional high-tech methods.

The current standards of care for assessing a patient’s ability to swallow, fiber-optic endoscopy and barium testing, are time-consuming, invasive and expensive to perform. The bedside swallowing evaluation (BSE), by comparison, takes only seconds to conduct and requires no special technology—merely a free hand, an ice chip and a cup of water—according to Texas researchers studying the technique.

Developed by speech pathologists, the BSE has now become the test of choice at University Medical Center Brackenridge, in Austin, said Carlos V.R. Brown, MD, trauma medical director at the facility and leader of the study. “We use this as our standard swallow evaluation for all extubated patients,” Dr. Brown said.

Time (q 15 sec per data point) Figure 1. Brain temperature tunnel (BTT) vs. forehead sleep pattern.

Times of voiding (up arrows), times of crossing (down arrows).

37.5 37

— Rectal — BTT

36.5 36 35.5 35 34.5 1 16 31 46 61 76 91 106 121 136 151 166 181 196 211 226 241 256 271 286 301 316 331 346 361 376 391 406 421 436 481 496

A

Time (q 60 sec per data point) Figure 2. Brain temperature tunnel (BTT) vs. rectal sleep pattern. Arrows point to times of voiding.

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For step-by-step instructions on how to start using Precedex and what to expect, please visit us at www.Precedex.com.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.2 Clinically significant episodes of bradycardia and sinus arrest have occurred in young, healthy volunteers with high vagal tone or with different routes of administration such as rapid intravenous or bolus administration.2 Transient hypertension has been observed primarily during the administration of the loading dose. Treatment has generally not been necessary, although a reduction in loading dose infusion rate may be desirable.2

Hypotension and bradycardia can occur and may necessitate medical intervention such as —Decreasing or stopping Precedex infusion —Increasing rate of IV fluid administration —Elevating lower extremities —Administering pressor agents such as atropine, ephedrine or glycopyrrolate2 Use with caution in patients with advanced heart block or severe ventricular dysfunction.2 The most common adverse effects (incidence >2%) are hypotension, bradycardia and dry mouth.2

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 B2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349.

4. Data on file. Hospira, Inc. Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-2830 Aug., 10. Printed in the USA.

Advancing Wellness™

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

Precedex

®

(dexmedetomidine hydrochloride injection) For Intravenous Use

� Only

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. Treatmentemergent 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)].

1

2

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.

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

3

1

INDICATIONS AND USAGE

5

1.1

Intensive Care Unit Sedation

Body System/ Adverse Event

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

5.2

Hypotension, Bradycardia, and Sinus Arrest

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.

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 situations where other vasodilators or negative chronotropic agents are administered, co-administration of Precedex could have an additive pharmacodynamic effect and should be administered with caution.

5.3

Transient Hypertension

5.4

Arousability

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.

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 If Precedex were to be administered for more than 24 hours and stopped abruptly, withdrawal symptoms similar to those reported for another alpha-2-adrenergic agent, clonidine, may result. These symptoms include nervousness, agitation, and headaches, accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma.

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

5.6

Hepatic Impairment

6

ADVERSE REACTIONS

6.1

Clinical Studies Experience

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)].

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),

Vascular Disorders Hypotension Hypertension Gastrointestinal Disorders Nausea Dry mouth Vomiting Cardiac Disorders Bradycardia Atrial fibrillation Tachycardia Sinus tachycardia Ventricular tachycardia General Disorders and Administration Site Conditions Pyrexia Hyperthermia Chills Edema peripheral Metabolism and Nutrition Disorders Hypovolemia Hyperglycemia Hypocalcemia Acidosis Respiratory, Thoracic and Mediastinal Disorders Atelectasis Pleural effusion Hypoxia Pulmonary edema Wheezing Psychiatric Disorders Agitation Blood and Lymphatic System Disorders Anemia Injury, Poisoning and Procedural Complications Post-procedural hemorrhage Investigations Urine output decreased

All Precedex N = 1007 n (%)

Randomized Precedex Placebo N = 798 N = 400 n (%) n (%)

Propofol N = 188 n (%)

4

6

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

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

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

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

6.2 248 (25%) 123 (12%)

191 (24%) 101 (13%)

48 (12%) 76 (19%)

25 (13%) 7 (4%)

90 (9%) 35 (4%) 34 (3%)

73 (9%) 22 (3%) 26 (3%)

36 (9%) 4 (1%) 21 (5%)

20 (11%) 1 (1%) 6 (3%)

52 (5%) 44 (4%) 20 (2%) 6 (1%) 4 (0%)

36 (5%) 37 (5%) 15 (2%) 6 (1%) 4 (1%)

10 (3%) 13 (3%) 17 (4%) 2 (1%) 3 (1%)

0 14 (7%) 2 (1%) 4 (2%) 9 (5%)

35 (4%) 19 (2%) 17 (2%) 4 (0%)

31 (4%) 16 (2%) 14 (2%) 2 (0%)

15 (4%) 12 (3%) 13 (3%) 2 (1%)

8 (4%) 0 4 (2%) 4 (2%)

31 (3%) 17 (2%) 7 (1%) 6 (1%)

22 (3%) 15 (2%) 7 (1%) 5 (1%)

9 (2%) 7 (2%) 0 4 (1%)

9 (5%) 5 (3%) 4 (2%) 4 (2%)

29 (3%) 23 (2%) 16 (2%) 9 (1%) 4 (0%)

23 (3%) 16 (2%) 13 (2%) 9 (1%) 4 (1%)

13 (3%) 4 (1%) 8 (2%) 3 (1%) 1 (0%)

12 (6%) 12 (6%) 5 (3%) 5 (3%) 4 (2%)

20 (2%)

16 (2%)

11 (3%)

1 (1%)

19 (2%)

18 (2%)

7 (2%)

4 (2%)

15 (2%)

13 (2%)

10 (3%)

7 (4%)

6 (1%)

6 (1%)

0

4 (2%)

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 3. 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 3: Adverse Reactions With an Incidence >2%—Procedural Sedation Population Body System/ Precedex Placebo Adverse Event N = 318 N = 113 n (%) n (%) Vascular Disorders 173 (54%) 34 (30%) Hypotension1 Hypertension2 41 (13%) 27 (24%) Respiratory, Thoracic and Mediastinal Disorders 117 (37%) 36 (32%) Respiratory depression5 7 (2%) 3 (3%) Hypoxia6 Bradypnea 5 (2%) 5 (4%) Cardiac Disorders 45 (14%) 4 (4%) Bradycardia3 Tachycardia4 17 (5%) 19 (17%) Gastrointestinal Disorders Nausea 10 (3%) 2 (2%) Dry mouth 8 (3%) 1 (1%)

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 4: 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, Blood pressure fluctuation, General heart disorder, hypertension, hypotension, myocardial infarction Central and Peripheral Dizziness, headache, neuralgia, Nervous System Disorders neuritis, speech disorder, convulsion Gastrointestinal System Abdominal pain, diarrhea, Disorders vomiting, nausea Heart Rate and Rhythm Arrhythmia, ventricular Disorders arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia Liver and Biliary System Increased gamma-glutamyl Disorders transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase Metabolic and Nutritional Acidosis, respiratory acidosis, 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 Apnea, bronchospasm, dyspnea, Disorders hypercapnia, hypoventilation, hypoxia, pulmonary congestion Skin and Appendages Increased sweating Disorders 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.

Manufactured and Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA Licensed from: Orion Corporation, Espoo, Finland Reference EN-1937 Printed in USA

1 2 I A n e s t h e s i o l o g y N e w s . c o m D e c e m b e r 2 0 1 0

PRN Juggernaut continued from page 1

As an undergraduate, I had begun smoking marijuana. Unlike many of my friends, though, I could With the help of a drug addiction, I have destroyed never get only a little high. I had to become totally my career, marriage, relationships with my two won- wrecked. Fortunately, I usually smoked indoors, derful sons and ability to make a living. where I hovered at the ceiling. If I had been outside, When I was 16 years old, my father asked me what I would have become an extra-solar system probe.

I planned to pursue in college. I told him medicine. It seems odd to me in retrospect that I didn’t drink My father had wanted to be a doctor. But he came much then. Ardent spirits stressed my gastrointestifrom the ghetto and never had the opportunity to nal system. Even later, I was primarily a wine drinker. complete college, let alone go to medical school, so I suppose my choice was the one surest to gain his approval.

A street junkie has to do whatever Despite my father’s frustrated intellectual ambitions, he was nonetheless a great success. He had six brothis needed to get his next fix. He ers, and excepting the one who died in adolescence, five became millionaires. He had grown up in Win- has to scam, rob, steal, beg and go nipeg, Manitoba, in a cold water flat above a drugin hock to his dope man to get his store. His father was an immigrant who traded textile seconds with American Indians for vegetables that he next fix. A physician addict merely would peddle from a pushcart back in the city.

Nothing in today’s economy matches the inventivehas to fill out how many vials of ness and independence of such a small businessman.

The leap from pushcart to millionaire seemed to me Demerol, morphine or whatever to be exponential and I felt that to justify my own life, I had to be exponentially successful, too. That’s a his or her drug of choice is and naïve approach, of course—and unobtainable. Worse than simply unobtainable, trying to achieve such sucthe drug company will cheerfully cess was a blueprint for self-destruction. and dependably ship it along.

My grades were not spectacular, but with good MCAT scores and a few references, I managed to get into a midwestern medical school. This was during the Vietnam War, and failure to continue in uniI entered medical school, did the work—it was versity would have landed me in a rice paddy in not academically challenging—and achieved modSoutheast Asia, perhaps floating face down. I was erately good grades while studying about 15 hours moderately active in the anti-war movement, but my a week. This amazed most of my classmates. They issue was never the humanistic question of the war, were invariably stressed out from long nights of the destruction of the under-classes or the morality intensive cramming. It never occurred to me to study of killing. The issue was my own self-preservation. longer hours, however, and I dropped back about

By the Numbers: Substance Abuse and MDs Table. Specialties of 904 Addicted Physicians Admitted to 16 State PHPsa Physician Patients by Specialtyb

%

Family medicine

20

Internal medicine

13

Anesthesiology

11

Emergency medicine

7

Psychiatry

7

PHP, Physicians’ Health Programs a

Source: DuPont RL, McLellan AT, White WL, Merlo LJ, Gold MS. Setting the standard for recovery: Physicians’ Health Programs. J Subst Abuse Treatment. 2009;​36:​159-171. b Including only specialties that represented >5% of total physician patients.

17 67 26 67

The percentage of physicians with personal knowledge of a physician colleague who was impaired or incompetent to practice medicine.

The percentage of those physicians who reported the impaired or incompetent colleague to the proper authorities.

The percentage of anesthesiologists who had personal knowledge of a physician colleague who was impaired or incompetent to practice medicine.

The percentage of those anesthesiologists who reported the impaired or incompetent colleague to the proper authorities.

Source: Results of a survey, published in July 2010 in the Journal of the American Medical Association (JAMA 2010;304:187193), of 1,891 practicing physicians in the United States, representing anesthesiology, psychiatry, cardiology, pediatrics, general surgery and internal medicine.

nine months when the volume of work became overwhelming.

I had another reason to be carefree: A trust fund from my deceased mother provided me with all the essentials, and many luxuries, for life as a scholar.

A Series of Professional Disappointments After medical school, I took a rotating internship at a small, now defunct hospital in midtown Manhattan. The highest distinction of the staff was not medical excellence, but rather that most of them were published gourmets. This fit right into my hedonistic outlook on life. It was there to enjoy.

But New York was not the Midwest, and within a year or so I had exhausted my trust fund and needed another way to finance the lifestyle I did not want to abandon to my intern’s stipend. Soon I found a means: my future wife. She was the receptionist and secretary to the chief of surgery at our hospital.

Divorced from an accountant, her primary reason for working at such a job was to find a physician to marry.

Her parents were merchants and she had her own apartment. I gave up my lease and moved in with her.

She, in turn, was delighted at the prospect of getting her Husband the Doctor. I believe that to be my only qualification for matrimony.

Upon graduation, I moved to Florida, where I all but assured the failure of my fledgling practice. I located the office—which I renovated completely, using an interior designer and brand new equipment—in a part of town that was saturated with physicians. At the same time, I allowed my wife to dictate the terms of when I would and wouldn’t work, and I had to decline moonlighting gigs in emergency rooms—she said she “didn’t get married to sleep alone”—that would have sustained us financially while the practice was getting off the ground.

After about 12 months, we moved to Michigan, where I found a position in a large and seemingly well-run practice. The patients were largely blacks from Detroit, and the volume of cases gave me a great deal of practice at basic general practice skills.

But my initial impressions were ill-founded. The manager of the practice turned out to be a disbarred lawyer, and any prospects for my own advancement quickly evaporated.

While practicing there, I began to use opiates on occasion, in part to ease the anguish of my troubled marriage, in part to help me ignore my gnawing sense of financial insecurity. The temporary release was a temporary comfort.

Quickening Spiral After quitting the practice, I started to work in low-volume emergency rooms that would pay me to sleep while I was on duty. I began to use both opiates and benzodiazepines to sleep in the call room at night. On some mornings, I could not remember any of the patients whom I’d treated only hours earlier.

Then I came across a diamond in the rough, a general practice in the city that was largely neglected but possessed promise. The owner was a physician who was a gambler and took his daily cash to the racetrack in the afternoons. see juggernaut page 14

速

速

1 4 I A n e s t h e s i o l o g y N e w s . c o m D e c e m b e r 2 0 1 0

PRN Juggernaut continued from page 12 The clinic had an x-ray machine grandfathered in from a less stringent time, but it was inadequate to generate sufficient revenue for what I believed was my financial destiny. Where I saw potential, though, was in third-party payments. The gambler didn’t seem to have any interest in this stream of income, but I did. I bought the practice and quickly pushed third-party payments to the maximum.

As usual, my ambition for wealth outstripped my earnings, leaving me frustrated and depressed. Life at home offered no respite. The marriage of mutual convenience had devolved into a loveless disaster whose only bright spots were our two young sons.

I added laboratory services and saw that the technician was always working to capacity regardless of how remote the differential diagnosis was from the presenting symptoms. I looked up the reimbursement rates of procedures before adding them to my repertoire. Radioimmunoassays were especially lucrative.

When the volume of patients lagged, I lured them with drugs, promiscuously prescribing an opioid called pentazocine that was in vogue at the time.

Pentazocine was a Schedule IV controlled substance and in my own mind not very likely to incur the wrath of the government. When combined with pyribenzamine, it gave the user a heroin-like high. My clinic went to capacity; I was soon seeing 50 patients a day. All the while, I was escaping my conscience by using Demerol myself.

Soon, I came to resent the patients as an obstacle to my getting stoned and staying stoned. I hired other physicians to see patients while I remained in my office, stoned and “managing” the clinic.

The physicians I hired had problems of their own with drugs and alcohol. The mix was toxic, but I was too high—on Demerol and money—to recognize the looming disaster. Within two years of purchasing the clinic, I was being reimbursed almost $90,000 a week by third-party insurers, mostly Medicaid. I was so estranged from reality that I thought this was normal.

I thought the bubble never would—or could—burst.

Ease of an MD Junkie The dynamics of being an addicted physician are far different from those of a street junkie. A street junkie has to do whatever is needed to get his next fix. He has to scam, rob, steal, beg and go in hock to his dope man to get his next fix. A physician addict merely has to fill out how many vials of Demerol, morphine or whatever his or her drug of choice is and the drug company will cheerfully and dependably ship it along.

Doctors also get their pharmaceutical-grade fix on the cheap. A loaded syringe of Demerol cost me about 30 cents. A similar dose would run a street junkie more than $30. Being a physician, you can order 50 or 100 vials at a time. No hassles, no adulterants, a pure product for a pure addict. And the dose is constant—there’s no danger of accidentally giving yourself an overdose, no depending on another source. What a marvelous opportunity for ruin!

Eventually, I was using pentazocine, Demerol, morphine, butorphanol nasal spray and nalbuphine. All the while I was taking megadoses of oxazepam. It never occurred to me that I could function better

Parnall Correctional Facility in Jackson, Mich., where Dr. ­Freedland was an inmate.

without sleeping for a night than with sixty oxazepam in my system.

I should go over the actual mechanics of my drug use. I was almost exclusively an intramuscular user/ abuser/addict, although on occasion I took drugs intravenously. I would draw 3 cc of Demerol into a syringe and inject into my buttocks. In fact, I typically would draw up two or three syringes at a time.

I would do this many times, giving myself as many as six multiple-syringe injections a day.

happened, I would make clumsy attempts to treat the diseased tissue, taking antibiotics empirically, and on one desperate occasion, even performing cryosurgery on my buttocks. These efforts usually made the problem worse.

I had crafted a rather basic denial system: What I was doing wasn’t illegal because I was licensed to possess and use the controlled substances. I knew how the drugs were metabolized and excreted. I had complete control over the situation.

I had other rationalizations, too, more than I can remember. The main one was that I was trapped in a terrible marriage from which drugs provided the Within two years of purchasing only escape. Somehow, it never occurred to me that a rational (not rationalizing) person would tell his wife the clinic, I was being reimbursed and children to “find a good lawyer, rent an apartment and hire a decorator.” almost $90,000 a week by One day, shortly after giving myself a series of third-party insurers, mostly injections, I got into a bad car accident. My hands started to jerk and I lost control of the vehicle. I Medicaid. I was so estranged crashed, ironically enough, into a drugstore and put my head through the windshield in the process. A from reality that I thought this witness crossing the street pulled me from the wreck.

The emergency crew was told that I was jerking after was normal. I thought the bubble the accident—but it was jerking that caused the jerking, not a head injury. never would—or could—burst.

The accident caused a compression fracture of my T7 vertebra. The hospital staff asked me what my pain medication of choice was. Demerol, of course, Soon, instead of making me drowsy, the Demerol but not in my usual mega-doses. I had no visitors in would make me hyper-excitable after a brief ini- the hospital. tial drowsiness. The “locked door” syndrome was I was released a few days later, damaged but not endemic in my practice. I would lock my office door chastened. Not long after, while driving my loaner before injecting and reopen it after the initial effects car, I crashed into some road barriers. My wife was of the drug wore off. Clinic employees knew what challenging me nightly about my condition, accusing was going on. me of using drugs. Every night, I denied it.

At times, my buttocks would become necrotized and infected from the endless injections. When that (To be continued.)

D e c e m b e r 2 0 1 0

AnesthesiologyNews.com I 15

CL I N I CA L A N E STH E SI OL OG Y

L2 Block Offers Viable Option for Total Hip Patients Toronto—Continuous lumbar plexus block is standard after total hip arthroplasty, but the approach has been associated with insufficient analgesia and excessive motor blockade.

Those factors led Richa Wardhan, MD, and colleagues at the University of Pittsburgh Medical Center (UPMC) to explore the viability of an alternative method, continuous L2 paravertebral block, in this population of patients.

Interim analysis of their randomized, double-blind prospective study suggests that the two blocks provide similarly effective postoperative analgesia, although L2 paravertebral blocks appear to cause less motor weakness. The investigators reported their findings at the 2010 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 49).

The analysis included data on 16 patients, aged 18 to 75 years, scheduled for primary hip replacement surgeries performed by the same surgeon.

Seven patients received L2 paravertebral blocks; the rest received posterior lumbar plexus blocks.

An infusion of 0.625% bupivacaine at 10 mL per hour was started in the recovery room. Patients in both groups also had access to self-administered morphine once their pain scores exceeded 4 on a 10-point verbal scale.

Patient-controlled morphine was continued for 24 hours.

Additional pain relief was available once patients reached the floor, this time by nurse-administered 5-mL boluses of 0.0625% bupivacaine via catheter pump, administered no more than once per hour. Nurses also administered IV morphine every 30 minutes as needed.

The researchers found that 24-hour pain scores during physical therapy were virtually identical between the lumbar plexus (5.8±2.8) and L2 paravertebral block groups (5.6±3.15). Use of morphine also was similar between groups (28.1±17.3 vs. 26.2±19.8 mg, respectively), they reported.

Mobility also was assessed by the Timed Get Up and Go Test of ambulation. Patients who received lumbar plexus blocks completed the test in an average of 78.9±27.7 seconds, compared with 92.2±18.2 seconds for patients given L2 paravertebral blocks, a difference that was not statistically significant.

Although the L2 paravertebral block seems to have little, if any, edge over the lumbar plexus technique, it does provide anesthesiologists another

option in a surgical population that is predicted to grow exponentially in coming years, the researchers said.

“One advantage of the L2 paravertebral block is that you can do it with the patient in a sitting position, which is sometimes easier, particularly when you have to otherwise manage a lumbar plexus block on a morbidly obese patient,” said co-investigator Jacques E.

Chelly, MD, PhD, MBA, professor of anesthesiology and orthopedic surgery, vice chair of clinical research, and director of the Division of Acute Interventional Perioperative Pain and Regional Anesthesia at UPMC. “It is also easier to do because you don’t need nerve stimulation.”

“I think this block represents a refinement of a regional anesthetic technique

that we’ve been using for years,” said John C. Rowlingson, MD, professor of anesthesiology and director of the Acute Pain Center at the University of Virginia in Charlottesville. “Certainly there are different ways, but we need to ask ourselves if we can find a better way.

So I think the investigators are asking the right questions.”

—Michael Vlessides

INDICATION EXALGO® tablets are an extended release oral formulation of the opioid agonist hydromorphone hydrochloride that is indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

IMPORTANT RISK INFORMATION WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Proper Patient Selection EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.

EXALGO is for use in opioid tolerant patients only.

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.

Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain.

EXALGO is not intended for use as an as-needed analgesic.

EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.

• EXALGO is also contraindicated in patients who: - need management of mild pain or pain not expected to persist - have significant impaired respiratory function including those with acute or severe bronchial asthma or hypercarbia.

- have or are suspected to have paralytic ileus - have narrowed or obstructed gastrointestinal tract including those from previous surgery or “blind loops” in the GI tract - have known hypersensitivity to any components including hydromorphone hydrochloride and sulfites.

• Avoid concurrent use of alcohol and EXALGO. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. EXALGO may impair the ability to drive a car or operate machinery.

• Not intended in patients who have received MAO inhibitors within 14 days of starting EXALGO. • Use with caution and in reduced doses in older or debilitated patients, as well as patients with renal or hepatic insufficiency, Addison’s disease, delirium tremens, myxedema or hypothyroidism, prosthetic hypertrophy or urethral stricture, toxic psychosis. May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings. Consider use of an alternate analgesic in patients with severe renal impairment.

• Respiratory depression, which occurs more frequently in elderly or debilitated patients, is the chief hazard with EXALGO. • Most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation (31%), nausea (28%), vomiting, somnolence, headache, asthenia and dizziness. Serious adverse events could also include head injury, hypotensive effects, GI effects, cardiac arrest from overdose and precipitation of withdrawal.

• Use EXALGO with extreme caution in patients susceptible to intracranial effects of CO2 retention.

• Do not abruptly discontinue EXALGO Please see brief summary of Full Prescribing Information, including boxed warning on following pages.

COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. EXALGO is a registered trademark of Mallinckrodt Inc. © 2010 Mallinckrodt Inc., a Covidien company. MK8976 September 2010 Printed in USA.

Keep pain waiting.

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With 24-hour extended-release hydromorphone, EXALGO helps you keep pain at bay. You can minimize peaks and troughs at steady state for your opioid tolerant patients with moderate to severe chronic pain, and they can reduce their pill burden. To find out more, visit www.keeppainwaiting.com. ®

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C LI N I C A L A NES THES IO LO GY

Block Intervention Found Wanting in Bypass Weaning

C

ase studies suggesting that stellate ganglion blocks can prevent fatal pulmonary embolism in patients coming off cardiac bypass appear to overstate their benefits. A recent pilot study by Canadian researchers found that the blocks, when performed before the induction of general anesthesia in cardiac surgery patients, do not suppress pulmonary

artery pressure during weaning off bypass.

“We recently became aware of some case series showing that stellate ganglion block saved the lives of patients with life-threatening pulmonary embolism,” said Sebastien Garneau, MD, assistant professor of anesthesiology at the Montreal Heart Institute, who led the study. “The hypothetical BRIEF SUMMARY - Consult full prescribing information before use.

EXALGO™ (hydromorphone HCl) Extended-Release Tablets WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression [see Drug Abuse and Dependence (9)].

Proper Patient Selection EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of oral oxycodone/ day, 8 mg oral hydromorphone/day, 25 mg of oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer [see Indications and Usage (1) and Dosage and Administration (2)].

EXALGO is for use in opioid tolerant patients only [see Indications and Usage (1) and Dosage and Administration (2)].

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.1)].

Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain [see Indications and Usage (1)].

EXALGO is not intended for use as an as-needed analgesic [see Indications and Usage (1)].

EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5)].

CONTRAINDICATIONS Opioid Non-Tolerant Patients EXALGO is contraindicated in opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant.

Impaired Pulmonary Function EXALGO is contraindicated in patients with significant respiratory depression, especially in the absence of resuscitative equipment or in unmonitored settings and in patients with acute or severe bronchial asthma or hypercarbia.

Paralytic Ileus EXALGO is contraindicated in patients who have or are suspected of having a paralytic ileus.

Preexisting Gastrointestinal (GI) Surgery or Narrowing of GI Tract EXALGO is contraindicated in patients who have had surgical procedures and/or underlying disease that would result in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction.

Allergy or Hypersensitivity EXALGO is contraindicated in patients with known hypersensitivity to any of its components including the active agent, hydromorphone hydrochloride or known allergy to sulfite-containing medications [see Warnings and Precautions (5.8)].

WARNINGS AND PRECAUTIONS Information Essential for Safe Administration EXALGO tablets are to be swallowed whole, and are not to be broken, chewed, crushed, dissolved or injected. Taking broken, chewed, crushed, dissolved EXALGO or its contents leads to the rapid release and absorption of a potentially fatal dose of hydromorphone [see Boxed Warning].

EXALGO is for use only in opioid tolerant patients. Ingestion of EXALGO may cause fatal respiratory depression when administered to patients who are not opioid tolerant [see Boxed Warning].

EXALGO tablets must be kept in a secure place out of the reach of children. Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.

Misuse and Abuse EXALGO contains hydromorphone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit.

This should be considered when prescribing or dispensing EXALGO in situations where the healthcare professional is concerned about an increased risk of misuse, abuse, or diversion.

Breaking, crushing, chewing, or dissolving the contents of an EXALGO tablet results in the uncontrolled delivery of the opioid and poses a significant risk of overdose and death [see Drug Abuse and Dependence (9)].

If attempts are made to extract the drug from the hard outer shell for purposes of parenteral abuse, the injection of tablet excipients may be toxic and may result in lethal complications.

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. However, all patients treated with opioids, including EXALGO, require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

mechanism suggested by the authors was relief of reflexive sympathetic vasoconstriction. Since there are many similar features between pulmonary embolism and cardiopulmonary bypass, we began to wonder whether stellate ganglion block could help us to wean patients from cardiopulmonary bypass.”

The investigators studied 20 patients who underwent an ultrasound-guided Respiratory Depression Respiratory depression is the chief hazard of EXALGO. Respiratory depression occurs more frequently in elderly or debilitated patients as well as those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation, and when opioids are given in conjunction with other agents that depress respiration.

Use EXALGO with extreme caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea, myxedema, kyphoscoliosis or CNS depression. In these patients, even moderate therapeutic doses of hydromorphone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. In these patients, consider alternative non-opioid analgesics, and use EXALGO only under careful medical supervision at the lowest effective dose.

Interactions with Alcohol and Other CNS Depressants The concurrent use of EXALGO with other central nervous system (CNS) depressants, including but not limited to other opioids, illicit drugs, sedatives, hypnotics, general anesthetics, phenothiazines, muscle relaxants, other tranquilizers, and alcohol, increases the risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Use with caution and in reduced dosages in patients taking CNS depressants. Avoid concurrent use of alcohol and EXALGO [see Clinical Pharmacology (12.3)].

Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the respiratory depressant effects of EXALGO and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, EXALGO can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Hypotensive Effect EXALGO may cause severe hypotension. There is added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines, general anesthetics, or other agents that compromise vasomotor tone.

Administer EXALGO with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Gastrointestinal Effects Because the EXALGO tablet is nondeformable and does not appreciably change in shape in the GI tract, do not administer EXALGO to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: esophageal motility disorders small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel’s diverticulum). There have been reports of obstructive symptoms in patients with known strictures or risk of strictures, such as previous GI surgery, in association with the ingestion of drugs in nondeformable extended-release formulations.

The administration of EXALGO may obscure the diagnosis or clinical course in patients with acute abdominal condition.

It is possible that EXALGO tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Sulfites EXALGO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

MAO Inhibitors EXALGO is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Special Risk Groups EXALGO should be administered with caution in elderly (≥ 65 years) and debilitated patients and in patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease [see Use in Specific Populations (8)].

EXALGO should also be used with caution in the following conditions: adrenocortical insufficiency (e.g., Addison’s disease); delirium tremens; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and, toxic psychosis.

EXALGO may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Use in Pancreatic/Biliary Tract Disease EXALGO can cause an increase in biliary tract pressure as a result of spasm in the sphincter of Oddi. Caution should be exercised in the administration of EXALGO to patients with inflammatory or obstructive bowel disorders, acute pancreatitis secondary to biliary tract disease and in patients about to undergo biliary surgery.

Driving and Operating Machinery EXALGO may impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients accordingly. Also warn patients about the potential combined effects of EXALGO with other CNS depressants, including other opioids, phenothiazines, sedative/hypnotics, and alcohol [see Drug Interactions (7)].

Precipitation of Withdrawal Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should not be administered to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic, including EXALGO. In these patients, mixed agonists/antagonists analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. Do not abruptly discontinue EXALGO. Clinical conditions or medicinal products that cause a sudden and significant shortening of gastrointestinal transit time may result in decreased hydromorphone absorption with EXALGO and may potentially lead to withdrawal symptoms in patients with a physical dependence on opioids.

ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Respiratory Depression [see Warnings and Precautions (5.3)] • Head Injury and Increased Intracranial Pressure [see Warnings and Precautions (5.5)] • Hypotensive Effect [see Warnings and Precautions (5.6)] • Gastrointestinal Effects [see Warnings and Precautions (5.7)] • Cardiac Arrest [see Overdosage (10)] • Precipitation of Withdrawal [see Warnings and Precautions (5.13)]

left stellate ganglion block immediately before induction of general anesthesia, and 20 matched controls. Patients who received the blocks experienced marked improvement in the ratio of PaO2 to FiO2 (mean difference, 77 mm Hg; P=0.0001).

These patients also experienced a mild reduction of right ventricular fractional area change (P=0.0331) Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

EXALGO was administered to a total of 2,524 patients in 15 controlled and uncontrolled clinical studies. Of these, 423 patients were exposed to EXALGO for greater than 6 months and 141 exposed for greater than one year.

The overall incidence of adverse reactions in patients greater than 65 years of age was higher, with a greater than 5% difference in rates for constipation and nausea when compared with younger patients. The overall incidence of adverse reactions in female patients was higher, with a greater than 5% difference in rates for nausea, vomiting, constipation and somnolence when compared with male patients.

A 12-week double-blind, placebo-controlled, randomized withdrawal study was conducted in opioid tolerant patients with moderate to severe low back pain [see Clinical Studies (14)]. A total of 447 patients were enrolled into the open-label titration phase with 268 patients randomized into the double-blind treatment phase. The adverse reactions that were reported in at least 2% of the patients are contained in Table 1.

Table 1.

Number (%) of Patients with Adverse Reactions Reported in ≥2% of Patients with Moderate to Severe Low Back Pain During the Open-Label Titration Phase or Double-Blind Treatment Phase by Preferred Term Preferred Term Open-Label Double-Blind Treatment Phase Titration Phase EXALGO (N=447) EXALGO (N=134) Placebo (N=134) Constipation 69 (15) 10 (7) 5 (4) Nausea 53 (12) 12 (9) 10 (7) Somnolence 39 (9) 1 (1) 0 (0) Headache 35 (8) 7 (5) 10 (7) Vomiting 29 (6) 8 (6) 6 (4) Drug Withdrawal Syndrome 22 (5) 13 (10) 16 (12) Pruritus 21 (5) 1 (1) 0 (0) Dizziness 17 (4) 3 (2) 2 (1) 16 (4) 2 (1) 6 (4) Asthenia a Insomnia 13 (3) 7 (5) 5 (4) Diarrhea 13 (3) 5 (4) 9 (7) Back Pain 13 (3) 6 (4) 8 (6) Dry Mouth 13 (3) 2 (1) 0 (0) Edema Peripheral 13 (3) 3 (2) 1 (1) Hyperhidrosis 13 (3) 2 (1) 2 (1) 10 (2) 2 (1) 0 (0) Anorexia b Arthralgia 9 (2) 8 (6) 3 (2) Anxiety 9 (2) 0 (0) 4 (3) 9 (2) 4 (3) 3 (2) Abdominal Pain c Muscle Spasms 5 (1) 3 (2) 1 (1) Weight Decreased 3 (1) 4 (3) 3 (2) a b c

Fatigue was grouped and reported with asthenia Decreased appetite was grouped and reported with anorexia Abdominal pain upper was grouped and reported with abdominal pain

The adverse reactions that were reported in at least 2% of the total treated patients (N=2,474) in the 14 chronic clinical trials are contained in Table 2.

Table 2.

Number (%) of Patients with Adverse Reactions Reported in ≥2% of Patients with Chronic Pain Receiving EXALGO in 14 Clinical Studies by Preferred Term Preferred Term All Patients (N=2,474) Constipation 765 (31) Nausea 684 (28) Vomiting 337 (14) Somnolence 367 (15) Headache 308 (12) Asthenia a 272 (11) Dizziness 262 (11) Diarrhea 201 (8) Pruritus 193 (8) Insomnia 161 (7) Hyperhidrosis 143 (6) Edema Peripheral 135 (5) b Anorexia 139 (6) Dry Mouth 121 (5) Abdominal Pain c 115 (5) Anxiety 95 (4) Back Pain 95 (4) Dyspepsia d 88 (4) Depression 81 (3) Dyspnea e 76 (3) Muscle Spasms 74 (3) Arthralgia 72 (3) Rash 64 (3) Pain in Extremity 63 (3) Pain 58 (2) Drug Withdrawal Syndrome 55 (2) Pyrexia 52 (2) Fall 51 (2) Chest Discomfort f 51 (2) a b c d e f

Fatigue was grouped and reported with asthenia Decreased appetite was grouped and reported with anorexia Abdominal pain upper was grouped and reported with abdominal pain Reflux esophagitis, gastroesophageal reflux disease and Barrett’s esophagus were grouped and reported with dyspepsia Dyspnea exacerbated and dyspnea exertional were grouped and reported with dyspnea Chest pain and non-cardiac chest pain were grouped and reported with chest discomfort

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CL I N I CA L A N E STH E SI OL OG Y and tricuspid annulus displacement (P=0.0048), which could increase a patient’s risk for heart failure, stroke and sudden cardiac death.

But as Dr. Garneau reported at the 2010 annual meeting of the Canadian Anesthesiologists’ Society (abstract 791966), other than increased central venous pressure in patients who received blocks (P=0.0184), the researchers found no differences between groups in any hemodynamic variables during the procedure.

The following Adverse Reactions occurred in patients with an overall frequency of <2% and are listed in descending order within each System Organ Class: Cardiac disorders: palpitations, tachycardia, bradycardia, extrasystoles Ear and labyrinth disorders: vertigo, tinnitus Endocrine disorders: hypogonadism Eye disorders: vision blurred, diplopia, dry eye, miosis Gastrointestinal disorders: flatulence, dysphagia, hematochezia, abdominal distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, diverticulum, gastrointestinal motility disorder, large intestine perforation, anal fissure, bezoar, duodenitis, ileus, impaired gastric emptying, painful defecation General disorders and administration site conditions: chills, malaise, feeling abnormal, feeling hot and cold, feeling jittery, hangover, difficulty in walking, feeling drunk, hypothermia Infections and infestations: gastroenteritis, diverticulitis Injury, poisoning and procedural complications: contusion, overdose Investigations: weight decreased, hepatic enzyme increased, blood potassium decreased, blood amylase increased, blood testosterone decreased, oxygen saturation decreased Metabolism and nutrition disorders: dehydration, fluid retention, increased appetite, hyperuricemia Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: tremor, sedation, hypoesthesia, paraesthesia, disturbance in attention, memory impairment, dysarthria, syncope, balance disorder, dysgeusia, depressed level of consciousness, coordination abnormal, hyperesthesia, myoclonus, dyskinesia, hyperreflexia, encephalopathy, cognitive disorder, convulsion, psychomotor hyperactivity Psychiatric disorders: confusional state, nervousness, restlessness, abnormal dreams, mood altered, hallucination, panic attack, euphoric mood, paranoia, dysphoria, listless, crying, suicide ideation, libido decreased, aggression Renal and urinary disorders: dysuria, urinary retention, urinary frequency, urinary hesitation, micturition disorder Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction Respiratory, thoracic and mediastinal disorders: rhinorrhoea, respiratory distress, hypoxia, bronchospasm, sneezing, hyperventilation, respiratory depression Skin and subcutaneous tissue disorders: erythema Vascular disorders: flushing, hypertension, hypotension DRUG INTERACTIONS CNS Depressants The concomitant use of EXALGO with central nervous system depressants such as hypnotics, sedatives, general anesthetics, antipsychotics and alcohol may cause additive depressant effects and respiratory depression. Additionally, hypotension and profound sedation or coma could occur. When this combination is indicated, the dose of one or both agents should be reduced. The concomitant use of alcohol should be avoided [see Clinical Pharmacology (12.3)].

Monoamine Oxidase (MAO) Inhibitors MAO inhibitors may cause CNS excitation or depression, hypotension or hypertension if co-administered with opioids including EXALGO. EXALGO is not intended for patients taking MAO inhibitors or within 14 days of stopping such treatment.

Mixed Agonist/Antagonist Opioid Analgesics The concomitant use of EXALGO with morphine agonist/antagonists (buprenorphone, nalbuphine, pentazocine) could lead to a reduction of the analgesic effect by competitive blocking of receptors, thus leading to risk of withdrawal symptoms. Therefore, this combination is not recommended.

Anticholinergics Anticholinergics or other medications with anticholinergic activity when used concurrently with EXALGO may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Cytochrome P450 Enzymes In vitro data suggest that hydromorphone in clinically relevant concentrations has minimal potential to inhibit the activity of human hepatic CYP450 enzymes including CYP1A2, 2C9, 2C19, 2D6, 3A4, and 4A11.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hydromorphone crosses the placenta. EXALGO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.2)].

Hydromorphone was not teratogenic in pregnant rats given oral doses up to 6.25 mg/kg/day or in pregnant rabbits administered oral doses up to 25 mg/kg/day during the period of organogenesis (~1.2 times the human exposure following 32 mg/day).

Hydromorphone administration to pregnant Syrian hamsters and CF-1 mice during major organ development revealed teratogenicity likely the result of maternal toxicity associated with sedation and hypoxia. In Syrian hamsters given single subcutaneous doses from 14 to 258 mg/kg during organogenesis (gestation days 8 to 10), doses ≥ 19 mg/kg hydromorphone produced skull malformations (exencephaly and cranioschisis). Continuous infusion of hydromorphone (5 mg/kg, s.c.) via implanted osmotic mini pumps during organogenesis (gestation days 7 to 10) produced soft tissue malformations (cryptorchidism, cleft palate, malformed ventricals and retina), and skeletal variations (supraoccipital, checkerboard and split sternebrae, delayed ossification of the paws and ectopic ossification sites). The malformations and variations observed in the hamsters and mice were at doses approximately three-fold higher and <one-fold lower, respectively, than a 32 mg human daily oral dose on a body surface area basis.

Nonteratogenic Effects In the pre- and post-natal effects study in rats, neonatal viability was reduced at 6.25 mg/kg/day (~1.2 times the human exposure following 32 mg/day).

Neonates born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

Approaches to the treatment of the syndrome have included supportive care and, if indicated, drugs such as paregoric or phenobarbital.

The MB fraction of creatine kinase was 1.5 times higher in the block group (P=0.0211), although no patient developed myocardial infarction.

“We found a difference for an increase in troponins in the stellate ganglion block group,” Dr. Garneau told Anesthesiology News. “That was a bit surprising at first, because we thought the block would be protective, since it’s used to treat refractory angina.” The incidence of arrhythmia did not appear to differ between groups; however, the Labor and Delivery EXALGO is not recommended for use in women during and immediately prior to labor and delivery. Administration of EXALGO to the mother shortly before delivery may result in some degree of respiratory depression in the neonate.

However, neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression.

Nursing Mothers Low concentrations of hydromorphone have been detected in human milk in clinical trials. Withdrawal symptoms can occur in breastfeeding infants when maternal administration of an opioid analgesic is stopped. Nursing should not be undertaken while a patient is receiving EXALGO since hydromorphone is excreted in the milk.

Pediatric Use The safety and effectiveness of EXALGO in pediatric patients 17 years of age and younger have not been established.

Geriatric Use Elderly patients have been shown to be more sensitive to the adverse effects of EXALGO compared to the younger population. Therefore, use extra caution when prescribing EXALGO in elderly patients and reduce the initial dose.

Neonatal Withdrawal Syndrome Chronic maternal use of opiates or opioids during pregnancy coexposes the fetus. The newborn may experience subsequent neonatal withdrawal syndrome (NWS). Manifestations of NWS include irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, weight loss, and failure to gain weight. The onset, duration, and severity of the disorder differ based on such factors as the addictive drug used, time and amount of mother’s last dose, and rate of elimination of the drug from the newborn. Approaches to the treatment of this syndrome have included supportive care and, when indicated, drugs such as paregoric or phenobarbital.

Hepatic Impairment In a study that used a single 4 mg oral dose of immediate-release hydromorphone tablets, four-fold increases in plasma levels of hydromorphone (Cmax and AUC0- ) were observed in patients with moderate hepatic impairment (Child-Pugh Group B). Start patients with moderate hepatic impairment on a reduced dose and closely monitored during dose titration.

The pharmacokinetics of hydromorphone in severe hepatic impairment patients have not been studied. Further increase in Cmax and AUC0- of hydromorphone in this group is expected, therefore, use an even more conservative starting dose [see Dosage and Administration (2.4)].

Renal Impairment Renal impairment affected the pharmacokinetics of hydromorphone and its metabolites following administration of a single 4 mg dose of immediate-release tablets. The effects of renal impairment on hydromorphone pharmacokinetics were two-fold and four-fold increases in plasma levels of hydromorphone (Cmax and AUC0-48h) in moderate (CLcr = 40 to 60 mL/min) and severe (CLcr < 30 mL/min) impairment, respectively. In addition, in patients with severe renal impairment hydromorphone appeared to be more slowly eliminated with longer terminal elimination half-life (40 hours) compared to subjects with normal renal function (15 hours). Start patients with moderate renal impairment on a reduced dose and closely monitored during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Dosage and Administration (2.4)].

DRUG ABUSE AND DEPENDENCE Controlled Substance EXALGO contains hydromorphone, a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. EXALGO can be abused and is subject to misuse, abuse, addiction, and criminal diversion [see Warnings and Precautions (5.2)]. The high drug content in the extended release formulation adds to the risk of adverse outcomes from abuse.

Abuse All patients treated with opioids, including EXALGO, require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.

“Drug-seeking” behavior is very common to addicts and drug abusers. Drugseeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.

In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since EXALGO may be diverted for non-medical use, careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

EXALGO is intended for oral use only. Misuse or abuse by breaking, crushing, chewing, or dissolving EXALGO poses a hazard of overdose and death. This risk is increased with concurrent abuse of EXALGO with alcohol and other substances.

With intravenous abuse, the tablet excipients, especially polyethylene oxide, can be expected to result in necrosis and inflammation of cardiac tissues. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Dependence Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.

Tolerance could occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms [see Use in Specific Populations (8.1, 8.2)].

OVERDOSAGE Symptoms Acute overdosage with opioids can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia, hypotension and death. The extended release characteristics of EXALGO should also be taken into account when treating the overdose. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.

Deaths due to overdose could occur with abuse and misuse of EXALGO. Due to the delayed mean apparent peak plasma level of EXALGO occurring at 16 hours following administration as well as the 11 hour mean elimination half-life of EXALGO, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 24 to 48 hours.

Treatment Give primary attention to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Employ supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.

The pure opioid antagonists, such as naloxone and naltrexone are specific antidotes to respiratory depression from opioid overdose. Since the duration of reversal would be expected to be less than the duration of action of hydromorphone in EXALGO, the patient must be carefully monitored until spontaneous respiration is reliably re-established. EXALGO will continue to release and add to the hydromorphone load for up to 24 hours after administration and the management of an overdose should be monitored accordingly, at least 24 to 48 hours beyond the overdose.

Only administer opioid antagonists in the presence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose. In patients who are physically dependent on any opioid agonist including EXALGO, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

OROS is a registered trademark of ALZA Corporation.

EXALGO is a trademark of Mallinckrodt Inc. COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and/or internationally registered trademarks of Covidien AG. © 2010 Mallinckrodt Inc., a Covidien company Distributed by: Mallinckrodt Brand Pharmaceuticals, Inc. Hazelwood, MO 63042 USA Issued 03/2010-B

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study was underpowered to detect such a difference.

Yet, the study’s most surprising finding was the superior oxygenation found in the stellate ganglion block group, Dr. Garneau said. “So far, we can only hypothesize as to why that occurred.

It’s likely because of the improvement in the ventilation/perfusion ratio of lung areas, but we cannot prove that with our data so far.”

This, he added, might suggest another mechanism for the effect of stellate ganglion block on pulmonary embolism. “Instead of just abolishing the reflex sympathetic vasoconstriction, it could be because of a better ventilation-perfusion relationship.”

Nevertheless, given that the block offers little protection against pulmonary artery pressure increases, Dr. Garneau could not recommend its use in this patient population. “We are planning to do another investigation in patients who are at higher risk for pulmonary hypertension after weaning from [cardiopulmonary bypass],” he said, “but so far in this population, it did not show any benefits.”

Giuseppe Trunfio, MD, director of cardiac anesthesia at Maimonides Medical Center in New York City, said he found the study intriguing. “The key issue is how to identify the subgroup of patients that may benefit from this procedure preoperatively,” Dr. Trunfio said.

“Stellate ganglion blockade is not without risk. Even when ultrasound-guided, it would be difficult to justify in a routine on-pump cardiac case where the incidence of clinically significant postoperative pulmonary dysfunction is relatively low.

“In the United States,” Dr. Trunfio added, “most cardiac anesthesiologists would not be necessarily familiar with this block, and would probably be somewhat reluctant to perform a block in a very vascular area in patients scheduled to be fully anticoagulated without a clearly favorable risk­–benefit ratio.”

—Michael Vlessides

2 0 I A n e s t h e s i o l o g y N e w s . c o m D e c e m b e r 2 0 1 0

C LI N I C A L A NES THES IO LO GY

Hospital Project Predicts Pain Statistical model may help treat inpatients

B

y compiling data on diagnoses, pain scores and post-discharge satisfaction from almost 40,000 patients, researchers in New York City have created a statistical model to predict which patients are more likely to experience moderate or severe pain during their hospital stay.

“It’s not rocket science, it’s logical, but most centers do not have the resources to do this type of analysis,” said the study’s co-author David L. Reich, MD, professor and chair of anesthesiology at Mount Sinai School of Medicine. “We think we can improve patient satisfaction by targeting resources.”

Results of the study were presented at the 2010 annual meeting of the American Society of Anesthesiologists in San Diego, in San Diego (abstract 1157).

The investigators retrieved post-discharge patient satisfaction information through the Hospital Care Quality Information from the Consumer Perspective survey (HCAHPS) and initially demonstrated that inpatient maximum visual analogue scale (VAS) Advertisement

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pain scores were strongly negatively correlated with Table. Odds Ratios for Predicting Inpatient Pain HCAHPS pain satisfaction.

Odds Then, to create the predictive model, Dr. Reich Ratio 95% CI Variable and colleagues collected a broader range of information, including VAS pain scores, principal diagno- Length of stay (LOS) 1-3 d vs.

2.48 2.25-2.72 sis, medication use and hospital length of stay (LOS) LOS=1 on 38,544 adult inpatients admitted to Mount Sinai 4.34 3.93-4.78 between January 2008 and April 2009. The research- LOS 3-7 d vs. LOS=1 ers used half the cohort to create the statistical model LOS >7 d vs. LOS=1 7.26 6.49-8.11 and the other half to validate it.

‘It’s not rocket science, it’s logical, but most centers do not have the resources to do this type of analysis.’

—David L. Reich, MD

A patient’s likelihood of experiencing moderate or severe pain was significantly associated with a variety of factors, including LOS, ethnicity, medication use and age. Patients were significantly more likely to experience moderate to severe pain if they remained in the hospital for two to three days (odds ratio [OR], 2.48; 95% confidence interval [CI], 2.25-2.72), three to seven days (OR, 4.34; 95% CI, 3.93-4.78) or more than a week (OR, 7.26; 95% CI, 6.49-8.11) compared with patients who stayed one day.

Hispanic and black patients had a slightly greater likelihood of reporting more severe pain than white patients (OR, 1.10; 95% CI, 1.01-1.20; OR, 1.11; 95% CI, 1.01-1.21, respectively), whereas Asian patients were less likely (OR, 0.79; 95% CI, 0.670.94). Patients who were older (measured by 10-year increments) experienced less moderate or severe pain than younger patients. Women experienced worse pain than men, as did patients taking antidepressants, anxiolytics or other central nervous system medications.

Compared with patients in the department of medicine, those in general surgery experienced moderate or severe pain more often (OR, 3.71; 95% CI, 3.36-4.09). Transplantation and orthopedic patients (OR, 7.68; 95% CI, 6.34-9.29) also had more pain, whereas gynecology patients had less pain.

“Our model actually had pretty good predictive value,” Dr. Reich said. “If the model predicted pain severity greater than 75%, we called that a stage 1 alert, and if it was above 90%, that was a stage 2 alert.”

Once those alerts are sounded, physicians and nurses involved in a patient’s care can target pain management resources as appropriate.

Dr. Reich already is using the model to guide treatment. He has created an intranet page that allows nurses to calculate the likelihood that a new patient will experience moderate or severe pain and has initiated a neuraxial morphine program on the orthopedic surgical unit.

Hispanic vs. Caucasian

1.10

1.01-1.20

Black vs. Caucasian

1.11

1.01-1.21

Asian vs. Caucasian

0.79

0.67-0.94

Surgery vs. Medicine (Med)

3.71

3.36-4.09

Cardiothoracic surgery vs. Med

1.16

1.01-1.34

Gynecologic surgery vs. Med

0.84

0.72-0.98

Orthopedics vs. Med

7.68

6.34-9.29

Rehabilitation Med vs. Med

2.80

2.38-3.29

Neurosurgery vs. Med

2.80

2.34-3.36

Neurology vs. Med

0.73

0.58-0.90

Urology vs. Med

2.06

1.71-2.49

Age, per 10-y increase, male

0.77

0.75-0.79

Age, per 10-y increase, female

0.83

0.80-0.85

Antidepressant vs. none

1.23

1.11-1.3

Anxiolytic vs. none

1.22

1.13-1.31

Other CNS vs. none

1.25

1.14-1.36

P<0.001 for all variables.

CI, confidence interval; CNS, central nervous system

Asokumar Buvanendran, MD, associate professor of anesthesiology at Rush Medical College and director of orthopedic anesthesia at Rush University Medical Center in Chicago, said the concept of predicting which patients’ pain might be worse has become an important topic, given that post-discharge pain satisfaction surveys are being used to compare hospitals around the country. But he added that this particular study’s results might not be applicable outside Mount Sinai Hospital. At Rush, for example, hospital medicine patients tend to have worse pain and pain management satisfaction than surgery patients, not the reverse.

Still, Dr. Buvanendran said, targeting resources where they are needed most shows promise in pain management in hospitals. “I think with increased awareness, patients might have better care and there may even be changes in the protocols and the treatment algorithms,” he said.

—Dave Levitan

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Preoperative β-Blockade Appears To Benefit Noncardiac Surgical Patients Pilot study hints at importance of timing

D

ebate has long surrounded the use of perioperative β-blockade: Just when do the benefits outweigh the risks? The answer may lie in the timing, according to results of an observational study

presented at the 2010 annual meetings of the Canadian Anesthesiologists’ Society (abstract 802692) and the American Society of Anesthesiologists (abstract A781).

The investigators found that patients

who presented for noncardiac surgery and who had been receiving β-blockers chronically had less than half the risk for cardiac complications and death as patients who started on the drug within 24 hours of the operation.

“We may need to be thinking about β-blockade chronically,” said lead researcher Scott Beattie, MD, deputy chief of anesthesia at Toronto General Hospital in Canada. “If people are at risk, they really should be started [on β-blockers] a couple of weeks before surgery.”

Two years ago, the results of a large international study found that β-blockers could cause more harm than good in noncardiac surgery (see “POISE Data Complicate Peri-op β-Blocker Therapy,” Anesthesiology News, June 2008, page 1). Although the drugs appeared to protect against heart attacks, they raised the risk for stroke and death.

‘We may need to be thinking about β-blockade chronically.’

—Scott Beattie, MD Despite criticism of the POISE study, the findings turned some surgical teams away from using β-blockers.

“I think that’s an overreaction to a study that only answers the question of whether people at risk for coronary disease, and who haven’t been on a β-blocker, should be started on one during the day of surgery,” said Dr. Beattie. “What would have happened in POISE had we started them weeks beforehand?”

This question motivated Dr. Beattie and his team to conduct a small pilot study using a prospective data set of more than 5,000 patients undergoing elective noncardiac surgeries at three hospitals in Toronto between 2008 and 2009. The researchers matched 202 pairs of these patients based on age, anemia, cardiac risk factors, type of β-blocker, type of surgery, need for blood transfusion and measurement of troponin. “We ended up with two groups who had exactly the same probability of being on chronic β-blockers,” Dr. Beattie said. “One population was on [β-blockers] an average of 10 days prior and the other started the drugs on the day of surgery.”

Of the patient pairs, 55% were at moderate to high risk for cardiac morbidity. Six patients (3%) taking β-blockers chronically met the composite end point, which included myocardial infarction, nonfatal cardiac arrest and in-hospital mortality; by comparison, 15 patients (7.4%) receiving a β-blocker acutely met the composite end point (P<0.05).

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One of the key functions of a β-blocker is to prevent rapid heart rate and the consequential increased risk for heart attack. At the same time, an adequate heart rate is necessary to maintain cardiac output, explained Martin London, MD, professor of anesthesia and perioperative care at the University of California School of Medicine in San Francisco.

“In the perioperative period [when] you change physiologic conditions in multiple directions and often at once, some of the effects of β-blockers are beneficial and some are detrimental,” said Dr. London. “If you drop the heart rate with a β-blocker and the amount of oxygen a patient needs to have delivered is still high, for example, they may be at risk for developing some kind of ischemic damage. It’s a fine balancing act.”

It may be that allowing the body ample time to adapt to the effects of β-blockade better prepares the patient for the additional stresses of surgery.

“Bodies change when drugs are on board,” said Jeff Silverstein, MD, professor of anesthesiology at Mount Sinai School of Medicine in New York City.

“When you give someone a medication over a prolonged period of time, you tend to make adjustments so that it’s actually doing what it’s supposed to do.”

Of course, having that extra time is not always practical. “It’s one thing if you’ve decided that you want your knee replaced,” Dr. Silverstein said.

“But, if you just had a colonoscopy last week and found out that you had a tumor, I don’t think anyone would say we would delay your surgery a month so you could have β-blockers started.”

The benefit of early and prolonged β-blockade before surgery was suggested as early as 1999, when Dutch researcher Don Poldermans, MD, PhD, and colleagues reported their findings in The New England Journal of Medicine (1999;341:1789-1794).

More research is needed before any recommendations are made, Dr. Beattie said. The latest study is small and has the inherent limitations of an observational study.

“There are a lot of unanswered questions that would be best answered in a large-scale, randomized trial,” Dr. London added. “The intellectual path that we need to take is knowing precisely what the beneficial and adverse effects of β-blockers are, and then coming up with a balance for each particular patient.”

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2 4 â&#x20AC;&#x201A; I â&#x20AC;&#x201A; A n e s t h e s i o l o g y N e w s . c o m D e c e m b e r 2 0 1 0

C LI N I C A L A NES THES IO LO GY

Awake or Asleep Tracheal Extubation?

New Data Point to Asleep Study of pediatric patients at risk for respiratory complications San Diegoâ&#x20AC;&#x201D;Children at high risk for respiratory complications after adenotonsillectomy have a higher rate of respiratory adverse events at emergenceâ&#x20AC;&#x201D;but not in the recovery roomâ&#x20AC;&#x201D; when extubation occurred while they were awake; the comparison group comprised children who were deeply anesthetized but spontaneously breathing when extubated, researchers have found.

The international team also concluded that awake extubation leads to a significantly higher incidence of coughing (P<0.001) and a tendency toward greater oxygen desaturation on emergence. There was a tendency toward a higher incidence of airway obstruction in children who were extubated asleep, but this was not associated with oxygen desaturation.

Britta von Ungern-Sternberg, MD, PhD, principal investigator and chair of pediatric anesthesia at Princess Margaret Hospital for Children in Perth, Australia, said they identified children at high risk for respiratory complications based on their recent large cohort study (Lancet 2010;â&#x20AC;&#x2039;376:â&#x20AC;&#x2039;773-783). â&#x20AC;&#x153;Since pediatric anesthetists are divided as to whether a deep or awake extubation is preferential in these children,â&#x20AC;? she said, â&#x20AC;&#x153;the current study was designed to test our observational results from our previous study in the setting of a randomized controlled trial.â&#x20AC;?

Dr. von Ungern-Sternberg enrolled into the trial 100 patients (none older than 16 years) undergoing elective adenotonsillectomy. All patients exhibited

at least one of the following risk factors for perioperative respiratory adverse events: current or recent (within the previous two weeks) upper respiratory tract infection; wheezing in the previous 12 months; dry nocturnal cough; wheezing with exercise; family history of asthma; eczema or hay fever; and passive smoking.

Deep anesthesia extubation (n=50) was defined as removal of the endotracheal tube during the surgical stage of general anesthesia, when the child was breathing spontaneously but airway reflexes were still depressed. Awake extubation (n=50) occurred if the endotracheal tube was removed when the child was awake, breathing adequately and with discernible airway reflexes.

The results of the study, presented at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A952), found that 29 patients (58%) in the awake extubation group experienced severe coughing on emergence, compared with four patients (8%) extubated while asleep. In addition, there was a trend toward increased oxygen desaturation in the awake extubation group (eight of 50 [16%] vs. two of 50 [4%], respectively; P=0.1).

On the other hand, patients who were extubated during deep anesthesia tended to experience more airway obstruction than those who were extubated while awake (five of 50 [10%] vs. two of 50 [4%], respectively; P=0.4). The difference became statistically significant only when emergence and recovery were considered together (13 of 50 [26%] asleep vs. four of 50 [8%] awake; P=0.03).

Airway obstructions were easily treated with simple airway maneuvers, and were not associated with oxygen desaturation seeâ&#x20AC;&#x201A; awakeâ&#x20AC;&#x201A; page 28

A Chip Off the Old Block: Checklist Helps Train RA Residents

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So Imad T. Awad MBChB, director of acute pain services at Sunnybrook Health Sciences Centre, in Toronto, and his colleagues created a checklist of key steps in the process of administering ultrasound-guided regional anesthesia (left).

The list includes a mix of objective and subjective measures, such as whether a resident moves too tentatively or without purpose during a procedure or whether a stimulating needle delivers adequate current to do its job. â&#x20AC;&#x153;We started to use the competency score for elective residents who come to train in regional anesthesia in the block room for a month. In the first few days, they needed input and feedback from the assessors and educators. It is expected 1. Prop T ask er positi oning of 2. Cor patient that the score rect plac N ot ement allow ea Perform Perform sy visual of ultrasound ed ed improves by the machine ization 3. Cho Pe Po rf of or or re med ly both ice of co lative to rrect pr patient Well 4. Cor obe to third week and rect dept h, gain 5. Hol , and fo ds the pr cal zone last week of the obe ap choices 1 finger touching propriately (3 fingers the pati 6. Kno rotation,â&#x20AC;? Dr. Awad holding ent) wledge the prob or co side of e and probe co nfirmation of said. â&#x20AC;&#x153;This tool also scre rrespond 7. Sc s to whi en orientation anning ch side of anatom (i.e. whi of screen provided a strucch 8. Use y & prop ) of Doppl er identi er to ru fication 9. App le out va of target tured objective feedropriate sc ul ar struct needle ures (if 10. Mai alignmen applicab ntenance t back to discuss with le) of need needle le tip im ag e duri 11. Eff ng adva the residents after iciency ncemen of t re of gaining manoeuv needle re) tip posi completion of the 12. Rec tion im ogniti age (P.A .R.T (if nerv on of proper ne procedure and to go e stimul rv e st imulatio ation us 13. Ens n at appr ed) ure th opriate over things that were levels stimulat at current is no t lo wer ion is us than 0.2 ed) 14. Ask mA (if missed and how to for initia nerv e l as pi 15. Vis ration to ualisati rule out on of ne avoid making the same intravas 16. Ask edle tip cular in befo re in jection for 1-2 cc jection in intravas it mistakes in the future.â&#x20AC;? cular in ial injection to jection rule out 17. Ask intraneu patient ral an d Dr. Awadâ&#x20AC;&#x2122;s group preor at leas 18. Ask t look fo for pr r signs of pain/d cc/injec op er aspiration sented the checklist at iscomfo tion rate and incr rt ementa 19. Rec l injectio ognition the 2010 annual meeting n @ of 5 proper 20. Pe needle rform ap tip posi propriat tion of the American Society of 21. Ass e needle essmen tip adju t of ease stments 22. Rec of inject Anesthesiologists (abstract ognition ion (hig h pressu of co rrec nerve re) t local an aestheti A117). c spre

successful ultrasound-guided nerve block is easy to identify, just as is its opposite. But how do experts best coach residents to perform the procedure?

Most training programs in regional anesthesia rely more on generating experience performing blocks than on structured learning.

Although the former is essential, Canadian researchers say the latter is critical, too.

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D e c e m b e r 2 0 1 0

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C LI N I C A L A NES THES IO LO GY

Ultrasound-guided Combo Block Effective Pain Control Tool in Children Randomized controlled trial of laparoscopic appendectomy patients

P

ediatric patients receiving ultrasound-guided nerve blocks for laparoscopic appendectomy required less rescue pain medication than those receiving local infiltration, in a randomized controlled

trial. A combination of blocks—ultrasound-guided rectus sheath and ilioinguinal—was performed in the peripheral nerve block group. The findings were presented at the 2010 annual meeting of the American

Society of Anesthesiologists, in San Diego (abstract A978).

Santhanam Suresh, MD, vice chairman in the Department of Pediatric Anesthesiology at Children’s Memorial Hospital in Chicago, was involved

Now Available on CMEZone.com Fluid Responsiveness Monitoring In Surgical and Critically Ill Patients Clinical Impact of Goal-Directed Therapy To participate in this FREE CME/CE activity, log on to www.CMEZone.com and enter keyword “SR1047” Release Dates: September 1, 2010 (physicians), October 1, 2010 (nurse anesthetists)

Expiration Date: September 30, 2011

Accreditation Statement

Goal

Physician: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

The goal of this educational activity is to provide physicians and nurse anesthetists with information on the clinical rationale and recent evidence supporting optimal fluid responsiveness monitoring and management as part of goal-directed fluid management.

Nurse Anesthetist: This program has been approved by the American Association of Nurse Anesthetists for 1.0 CE credit; Code Number 33282; Expiration date September 30, 2011.

Faculty Maxime Cannesson, MD, PhD Associate Professor of Anesthesiology Department of Anesthesiology & Perioperative Care School of Medicine University of California, Irvine Orange, California

Patrice Forget, MD Department of Anesthesiology St-Luc Hospital Université Catholique de Louvain Brussels, Belgium

Medical Writer

Learning Objectives At the completion of this activity, participants should be better prepared to:

1

Devise an inventory of clinical challenges that are associated with fluid resuscitation and management of surgical and critically ill patients.

2

Delineate available fluid responsiveness monitoring methods and relative benefits and limitations associated with the use of each.

3

Appraise recent evidence supporting a clinical rationale for using fluid responsiveness monitoring as part of goal-directed fluid management in various acute care settings.

4

Compare the cost-effectiveness of available methods of monitoring fluid responsiveness, particularly in settings of surgery or intensive care.

Jointly sponsored by AKH Inc. and Applied Clinical Education.

George Ochoa

Distributed via: Supported by an educational grant from Masimo Corporation

To participate in this FREE CME/CE activity, log on to www.CMEZone.com and enter keyword “SR1047”

in the research and said that patients undergoing a laparoscopic appendectomy traditionally have low pain levels.

“However, we saw that these children had a fair amount of pain at the port site,” he said. “We need to find a new modality to solve the problem of limited sustained pain relief.”

The frequency of rescue pain medication administered to patients was significantly higher in those receiving standard local infiltration than in the group receiving ultrasound-guided blocks (P=0.04). “Children in the nerve block group had a longer duration of analgesia than children in the local anesthesia infiltration group for pain relief in the postoperative period,” Dr. Suresh said. Adverse-event profiles were similar between the two treatment groups.

Lisa Sohn, MD, attending physician in anesthesiology at Children’s Memorial, discussed the thought process behind the research. “Working from the TAP [transversus abdominis plane] block model, we wanted to target specific nerves in children,” she said.

“We were able to use less volume—and therefore keep toxicity levels low—and still have an effective block.”

Of 70 children (American Society of Anesthesiologists physical status I and II) enrolled in the trial, 65 were included in the final analysis. Eligible patients were aged 6 to 16 years (mean, 10 years). Patients were randomly assigned to two groups after being scheduled for surgery. The surgeon administered 0.25% bupivacaine at each port site to patients in group A; a study investigator administered ultrasound-guided rectus sheath and ilioinguinal nerve blocks bilaterally to patients in group B. Pain scores, rescue medications administered in the postanesthesia care unit, and opioid-related reactions such as drowsiness, itching, nausea and vomiting were documented by a blinded observer during the first 48 hours after surgery.

Dr. Suresh noted that ultrasoundguided regional anesthesia is gaining popularity for pediatric patients. “Rectus sheath blocks have shown efficacy in controlling pain following umbilical hernia repairs, as have ilioinguinal nerve blocks for groin surgery in pediatric patients,” he said.

Dr. Sohn suggested that this may be the first application of the use of these blocks in laparoscopic procedures. “We showed that nerve blocks are effective in laparoscopic appendectomies, which is what we were looking at,” she said. Further study of this approach is

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D e c e m b e r 2 0 1 0 Current file:

CMEzone1110-QV.indd

1ST PROOF LAYOUT APPROVED INITIALS AND DATE

Full Name of project

CME Zone Septeber 09

MAX sign-off

Finding the Perfect Fit: New Guide To ETT Sizes for Pediatric LMAs Style chges fr. prev.

Sales

Layout Date/Time

December 7, 2010 3:25 PM

Production

Editorial Date/Time

N

ot all endotracheal tubes are created equal, at least not when considering the challenge of threading one through the narrow opening in mask airway designed for a child.

Until now, anesthesiologists had to rely on their best guess for pairing the appropriate tube with a given mask size.

But a new reference table brings a muchneeded measure of rigor to the process.

“We wanted to know what tube fits best with what mask, so you can then use it to jimmy yourself out of a situation,” said Mary Landrigan-Ossar, MD, instructor of anesthesia at Children’s Hospital Boston, and a co-creator of the guide.

If, for example, a 12-pound infant wearing a size 1 LMA Classic (LMA North America) needs intubation with a cuffed endotracheal tube (ETT), how thick can that tube be?

Clinicians increasingly use LMAs as conduits for intubation, added Dr. Landrigan-Ossar, who presented her group’s table at the 2010 annual meeting of the Society for Airway Management in Chicago (abstract 11). The technique is particularly helpful when airway trouble arises after an LMA is in place. “Rather than taking the LMA

Copy Editor

Proof 1

FINAL OK INITIALS AND DATE

PROOF 1: 8/17 REV 1: REV 2: REV 3 REV 4 America, said the new results simREVwere 5 ilar to the company’s recommended sizREV 6 ing for placement of an ETT, with the REV 7 one exception that the researchers REV 8 were able to fit a thicker ETT through the REV 9

CL I N I CA L A N E STH E SI OL OG Y

Senior Editor

Revision #

AnesthesiologyNews.com I 27

Creative

size 2.5 Classic than what LMA has Trim Size King half vertical (31p0 x 78p) COMMENTS: ‘Rather than taking the out and fussing around, you can keep a recommended (5 mm).

Specsthan deteriorat4C situation stableColor rather The research team suggested that LMA out and fussing CMEzone1110-QV.indd ing,” she said. File Path this extra allowance might be due to The strategy also can be useful for the use of laryngeal forceps to stabilize around, you can keep patients in whom a good view with larthe ETT for removing the LMA, as yngoscopy is difficult to obtain: By first well as to the lubrication. a situation stable rather placing an LMA to start ventilation, an Ms. Clark also noted that LMA anesthesiologist can take time placing has introduced a new mask for adults, than deteriorating.’ the ETT. called the LMA Classic Excel, that is Still, no one had yet taken a sysdesigned to accept a larger size ETT —Mary Landrigan-Ossar, MD tematic look at the optimal pairing than the standard Classic. A child’s verof the two pieces. So Dr. Landrigansion is expected out later this year.

Ossar and her colleagues started mixThese new recommendations could No matter what conduit is used, the ing and matching 3- to 5.5-mm cuffed be especially helpful for the use of strategy comes with potential compliand uncuffed ETTs and LMA Classics uncuffed ETTs. “When you have an cations. “It is always risky, as you can ranging in size from 1 to 2.5. uncuffed tube, you have to guess right lose the tube,” Dr. Spiegel said. “It’s not The team attempted to pass lubri- on regarding the size,” explained Joan like with adults where you can jam it in cated tubes over a guide through the Spiegel, MD, instructor of anesthesiol- deep. These tubes are very small.” various LMAs and into the trachea of a ogy at Beth Israel Deaconess Medical “Get comfortable with the method,” child-sized mannequin, before remov- Center in Boston. “If the size isn’t right, Dr. Landrigan-Ossar advised. “Pracing the LMA over the ETT, stabilized air will leak around it. A cuff, on the tice it a thousand times on someone with laryngeal forceps. They repeated other hand, seals the airway.” healthy before you really need to use it.’ this procedure 20 times for each possiJennifer Clark, associate marketble pair, finding consistent results every ing product manager for LMA North —Lynne Peeples time.

For size 1 masks, they concluded that the best fits were with uncuffed and cuffed ETTs 3.5 and 3 mm in width, respectively. Similarly, for sizes 1.5, 2 Your premier source for practical, relevant and timely and 2.5, they advise uncuffed ETTs of continuing medical and pharmacy education 4, 4.5 and 5.5 mm and 3, 3.5 and 5 mm for cuffed tubes.

www.CMEZone.com

Table. Recommended Maximum Tracheal Tube Sizes To Pass Through An LMA Classic

Patient Size

Recommended Recommended Maximum Uncuffed Maximum Lo-Pro ETT ID (mm) Cuffed ETT ID (mm)

1

Neonates/infants up to 5 kg

3.5

3.0a

1.5

Infants 5-10 kg

4

3.0a,c

2 2.5

Infants/children 10-20 kg Children 20-30 kg

4.5 5.5

Expiring Soon

Mask Size

3.5

a,c

Clinical Urine Drug Testing During Opioid Therapy: A Case-Based Approach to Patient Monitoring

b

expires January 31, 2011

5.0

a

Pilot balloon will not fit through laryngeal mask airway conduit—utilize pilot balloon replacement technique.

b

Pilot balloon may not fit through laryngeal mask airway conduit—consider pilot balloon replacement technique.

c

Expiring Soon

A 3.5-mm uncuffed TT will pass through a size 1.5, and a 4-mm TT through a size 2, but it is very tight and too difficult compared with other maximum recommended ETTs, particularly during removal of the LMA Classic. Thus it may not pass fully through the laryngeal mask under all clinical conditions.

ETT, endotracheal tube; ID, internal diameter; TT, tracheal tube

Here are FREE educational activities available now on CMEZone.com

Fluid Responsiveness Monitoring In Surgical and Critically Ill Patients Clinical Impact of Goal-Directed Therapy Credit Also Available for CRNAs

SR1047

Brain Monitoring of Anesthetic Effect: An Evidence-Based Assessment of Clinical Impact and Safe Use

SR1058

expires September 30, 2011

expires April 1, 2012

warranted, according to Dr. Suresh.

Robert T. Wilder, MD, PhD, associate professor in the departments of anesthesiology, pain medicine and pediatrics at Mayo Clinic College of Medicine in Rochester, Minn., agreed that nerve blocks in pediatric patients is a “growth industry,” and that the blocks

are a useful tool for pain control, postoperatively. “We are seeing more and more of them as the equipment, drugs and training continue to improve,” Dr. Wilder told Anesthesiology News. “I suspect that this trend will continue.”

—Evan Young

SR0960

Credit Also Available for CRNAs

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C LI N I C A L A NES THES IO LO GY

Bupivacaine Formulation Extends Local Relief

A

is already a component of other slowrelease drugs, including Pacira’s morphine product DepoDur, and Exparel has shown promise in other Phase II and III studies.

In the latest study, 26 patients received a single 75-mg injection of plain bupivacaine at the end of the hemorrhoidectomy. Three other groups, composed of 24, 25 and 25 patients, received 75, 225 and 300 mg, respectively, of Exparel.

Study results were presented at the 2010 annual meeting of the American Society of Anesthesiologists, in San Diego (abstract A1158).

By assessing pain scores at several time points after surgery, the investigators calculated area under the curve through 72 hours and showed advantages for Exparel over conventional bupivacaine at all doses tested (Figure; 75 mg, P=0.03; 225 and 300 mg, P<0.01 for both). The improvement in pain relief with Exparel remained significant through 96 hours after surgery (P=0.02, P<0.01 and P<0.001, respectively).

The long-acting formulation also

reduced patients’ need for opioid rescue medication. Of the patients given standard bupivacaine, 8% avoided the need for rescue, compared with 16%, 24% and 32% of the patients who received 75, 225 and 300 mg of Exparel, respectively.

Patients who received 300 mg of Exparel required significantly fewer opioids than did those given standard bupivacaine, while taking the analgesics later in their course of care. For example, patients who received 300 mg of the new agent took an average of 6 mg of opioids compared with 20 mg for those in the group that received conventional bupivacaine (P<0.01). Exparel users’ median time to first use of opioids was 19 hours, compared with eight hours for patients in the other group (P<0.01).

“I think [Exparel] has tremendous potential,” Dr. White said. “As people continue to increasingly utilize multimodal analgesia, obviously local anesthetics become an important part of the multimodal anesthetic regime. The

—Dave Levitan

400

AUC, 0-72 hours

randomized study of 100 patients undergoing hemorrhoidectomy found that a slow-release formulation of bupivacaine resulted in significantly longer local analgesia and decreased need for opioid rescue medication compared with plain bupivacaine.

The search for a viable long-acting anesthetic has been a frustrating one, said study co-author Paul F. White, PhD, MD, director of clinical research at Cedars-Sinai Medical Center in Los Angeles. “There have been multiple attempts, and for whatever reason it has proven to be much more difficult than anyone imagined.”

The liposomal formulation, called Exparel (Pacira Pharmaceuticals), uses the DepoFoam carrier of bupivacaine and releases the drug more slowly, allowing for longer analgesia. “Instead of having a six- to eight-hour half-life, as bupivacaine usually does, it extends its half-life to two to three days,” said Dr. White, a member of the Anesthesiology News editorial board. DepoFoam

whole strategy is to reduce and hopefully eventually eliminate the need for opioids, and I see drugs like this as potentially playing a key role in that process.”

Pacira will soon file a new drug application with the FDA for Exparel, according to Dr. White, who has received consulting fees from the company.

Eugene Viscusi, MD, associate professor of anesthesiology at Thomas Jefferson University in Philadelphia, said the DepoFoam carrier bodes well for this particular formulation of bupivacaine. “There is fairly extensive experience with the carrier, showing that it is safe, well tolerated, with little—if any— tissue reaction,” said Dr. Viscusi, adding that the evidence on Exparel looks “extremely promising.”

Dr. Viscusi, a member of the editorial board of Anesthesiology News, said that in the future it will be interesting to see if this bupivacaine formulation can be expanded into other indications, such as peripheral blocks or epidural use.

*P<0.05 * 200

0

Bupivacaine 75 mg

Exparel 75 mg

*

*

Exparel 225 mg

Exparel 300 mg

Figure. The dose-dependency of the AUC for postoperative pain scores from 0 to 72 hours in the bupivacaine and Exparel treatment groups.

AUC, area under the curve

+

+

+

+

Awake continued from page 24 or other complications. The incidence of bronchospasm and laryngospasm was similar between the two groups.

In an interview with Anesthesiology News, Dr. von Ungern-Sternberg said that because of the commonness of adenotonsillectomies—coupled with a high risk for respiratory complications in this patient population—it is vital that children receive optimal management perioperatively. She said that these results indicate that extubation during deep anesthesia may be beneficial in pediatric patients at high risk for respiratory complications who undergo adenotonsillectomy.

Cheryl K. Gooden, MD, associate

professor of anesthesiology and pediatrics at Mount Sinai Medical Center, in New York City, said the study results might have been more compelling if a control group with no risk factors (as defined by the study) had been included and the indication for adenotonsillectomy explained.

“The results of the study are not totally surprising,” Dr. Gooden said.

“While coughing is not unexpected following extubation, I am somewhat surprised by the high incidence observed in the awake extubated group of patients.

Also of particular note, I would have expected a higher incidence of desaturation in the deep extubated group of patients during emergence.”

—Michael Vlessides

D e c e m b e r 2 0 1 0

AnesthesiologyNews.com I 29

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P OLI C Y & M ANAG EMENT Index continued from page 1 require adjustment for baseline patient and procedural risks. However, the researchers said their new tool has two key advantages over existing reporting systems: It is simple, and it is free.

“The risk stratification index [RSI] is an accurate and transparent method of stratifying risk that uses only ICD-9 codes,” said anesthesiologist Daniel I. Sessler, MD, professor and chair of the Department of Outcomes Research

at the Cleveland Clinic, in Ohio, and lead author of the study. “Furthermore, we have put the system in the public domain so anyone can use it without charge.” A report on the score was published in the November issue of the journal Anesthesiology (2010;113:10261037), which also ran two editorials devoted to the study.

Dr. Sessler and his colleagues sought to develop a risk-adjustment method using administrative claims data to evaluate outcomes and performance on

national and individual hospital levels.

They gathered 35,179,507 patient-stay records from the Medicare Provider Analysis and Review, covering the years between 2001 and 2006.

Records were randomly assigned to development and validation sets. Aggregate risk associated with individual and procedure codes were used to create RSIs for the two main outcome measures, length of stay and mortality.

Postdischarge mortality rates for 31 days and one year after discharge were

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assessed and predicted by a single risk stratification model.

Separate models were used to predict length of Daniel I. Sessler, MD stay and in-hospital mortality.

Dr. Sessler’s group evaluated the performance of the index prospectively using data from the validation sets and from 103,324 adult surgical patients treated at the Cleveland Clinic.

The investigators used the C statistic to compare their method to the commonly used Charlson Comorbidity Index (CCI) and to determine which best predicts duration of hospitalization, in-patient mortality, and 30-day and one-year postdischarge mortality.

The RSI yielded C statistics for median length of stay and 30-day mortality of 0.86 and 0.84, which were well above generated by the CCI (Table).

Dr. Sessler noted that “nearly all risk was contained in the ‘diagnosis’ ICD-9 codes rather than the procedure codes.”

Furthermore, the new RSI showed only slight improvement when demographic information was added. “Patient risk is thus far better characterized by accumulated diagnosis codes than by age.”

Applicability for Performance Comparisons Dr. Sessler said that the RSI requires about 2,000 patients to make reliable predictions. “It is thus not meant to be used in individual patients, but it could easily be used to compare outcomes from even a small group practice or any hospital with national norms or regional organizations,” he said.

These comparisons could lead to process improvements that, in turn, might improve patient outcomes.

Richard P. Dutton, MD, MBA, executive director of the Anesthesia Quality Institute (AQI), agreed.

“For clinicians in general this system will provide a valid method for risk adjustment of outcomes,” Dr. Dutton said. “Because the methodology is in the public domain, coefficients can be gathered and calculated for other outcomes of interest, such as peri-op myocardial infarction.”

Dr. Dutton also said that robust risk-adjustment methodologies will be necessary to move toward an era of public reporting of provider and facility effectiveness. He also highlighted the potential impact of the index in anesthesiology.

“For anesthesiologists, this paper creates a methodology that will be

D e c e m b e r 2 0 1 0

POL I CY & M A N A G E ME N T

Measure

Median Length of Stay

In-hospital Mortality (overall)

In-hospital Mortality (30-day)

In-hospital Mortality (one-year)

Table. Comparison of C Statistics for RSI versus CCI

C Statistics

0.89

0.98

0.85

0.83

CCI

0.60

0.65

0.76

0.77

CCI, Charlson Comorbidity Index; RSI, Risk Stratification Index

replicated by the AQI over time in the National Anesthesia Clinical Outcomes Registry, allowing us to benchmark outcomes in a specifically surgical population,” Dr. Dutton said.

But Bobbie Jean Sweitzer, MD, professor of anesthesia and critical care at the University of Chicago, was less enthusiastic. “This scoring system is likely to have limited use for individual clinical anesthesiologists outside of what it may tell them about a particular hospital or hospital system where they may work or seek employment,” she said. “It does not have the granularity to help a particular practitioner gain insight into their own performance quality.”

Elizabeth Schulwolf, MD, associate faculty member in the Department of Medicine at the University of Chicago, also had some reservations about the RSI. “I am not sure how useful this predictive scoring system will be to generalists and anesthesiologists in everyday practice,” she told Anesthesiology News.

Dr. Schulwolf suggested that the system may be too complex statistically, and that it may not identify diagnoses before a given procedure. However, she noted, “the authors suggest that implementing this risk-adjustment model in hospital ranking systems may diminish ‘cherry picking’ to the extent it occurs.”

Dr. Dutton agreed that the new risk index would be of little utility for individual anesthesiologists. But he stressed its value for the specialty as a whole. “A system like this one is necessary for anesthesia practices because it will be used to risk-adjust their outcomes when they are benchmarked to other groups,” he said.

Administrative Data Dr. Sessler said that an important feature of the index is that it requires only administrative data. “The system can easily be applied without the substantial costs and difficulties associated with obtaining clinical data,” he said. “With appropriate risk stratification, there will be no benefit to hospitals that select the lowest-risk patients; and conversely, tertiary centers that accept the sickest patients will be able to maintain excellent risk-adjusted

AnesthesiologyNews.com I 31

outcomes. This is especially important for academic medical centers.

“The procedure, per se, mattered much less,” Dr. Sessler added. “Age, sex and race contributed almost no additional information. Thus, patient outcomes were, on average, largely a function of their accumulated diagnosis codes.”

Drs. Sweitzer and Schulwolf noted that individual clinical data are preferable to administrative data, but that compiling volumes of such information

is problematic. Both agreed that the approach taken by the Cleveland Clinic researchers has merit.

“It has been shown in other studies that administrative data is generally valid,” Dr. Schulwolf said. “Their model seems to be inclusive and the thresholds they set for inclusion of diagnostic codes are appropriate. Since the goal of their model is to allow for adjustments across many hospitals/ patient groups, use of administrative data is the most practical.”

Dr. Dutton noted that the pending change to ICD-10 (see Anesthesiology News, October 2008, page 1) and the use of “present on hospital admission” coding may further improve the accuracy of the system. “Like it or not, administrative data are going to be used to examine the quality of care we provide,” he said. “Having a validated means of risk-adjusting patient outcomes will be important to all anesthesiologists.”

—Rob Volansky

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P OLI C Y & M ANAG EMENT Patient Protection and Affordable Care Act

Turning a Mandatory Compliance Program Into a Strategic Advantage

W

hen I say “compliance program,” what thought pops into your head? Paperwork? Waste of time? Turkish prison?

The Patient Protection and

Affordable Care Act (PPACA), also known as Obamacare, mandates that physicians participating in Medicare or Medicaid have operating compliance programs. Note that these

programs must operate at the practice level; compliance cannot simply be outsourced to a billing company.

On Sept. 23, 2010, the Centers for Medicare & Medicaid Services (CMS)

took the first step in attempting to define what those mandatory compliance programs must look like by issuing proposed regulations.

Consistent with the probable first thought that popped into your head, the great majority of anesthesia groups Table. Core Elements of Proposed PPACA Compliance Program The development and distribution of written policies, procedures and standards of conduct to prevent and detect inappropriate behavior.

Amsterdam, the Netherlands

2011

Euroanaesthesia The European Anaesthesiology Congress

June 11-14

The designation of a chief compliance officer and other appropriate bodies (e.g., a corporate compliance committee) charged with the responsibility of operating and monitoring the compliance program and who report directly to high-level personnel and the governing body.

The use of reasonable efforts not to include any individual in the substantial authority personnel whom the organization knew, or should have known, has engaged in illegal activities or other conduct inconsistent with an effective compliance and ethics program.

The development and implementation of regular, effective education and training programs for the governing body, all employees, including highlevel personnel and, as appropriate, the organization’s agents.

The maintenance of a process, such as a hotline, to receive complaints and the adoption of procedures to protect the anonymity of complainants and to protect whistle-blowers from retaliation.

The development of a system to respond to allegations of improper conduct and the enforcement of appropriate disciplinary action against employees who have violated internal compliance policies, applicable statutes, regulations or federal health care program requirements.

The use of audits and/or other evaluation techniques to monitor compliance and assist in the reduction of identified problem areas.

Symposia Refresher Courses Workshops Industrial Symposia & Exhibition Abstract Presentations CME Accreditation EACCME - UEMS

Deadline abstracts: December 15th 2010 Online submission: www.euroanaesthesia.org

ESA Secretariat Phone +32 (0)2 743 32 90 Fax +32 (0)2 743 32 98 E-mail: registration@euroanaesthesia.org

The investigation and remediation of identified systemic problems, including necessary modifications to the organization’s compliance and ethics program.

PPACA, Patient Protection and Affordable Care Act

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POL I CY & M A N A G E ME N T will view mandatory compliance programs as a necessary evil: a cost. Not that they don’t understand the need to be compliant.

Because groups will have no choice if they wish to remain as providers of Medicare and Medicaid, they will begrudgingly adopt a compliance program. But, let’s be honest; only some will actually implement the program on an ongoing basis.

Importantly—and this is the central point of this article—a much smaller minority of group leaders will understand that a compliance program can be used as a further lens through which to focus group strategy in order to wring additional profits from, and opportunity for, one’s group. This should be your goal.

‘Obamacare’ and the Proposed Regulation The new health care reform law requires that physicians seeking to become Medicare and Medicaid providers establish a compliance program that meets specific core requirements to be adopted by the Secretary of the Department of Health and Human Services (HHS).

The proposed regulations, an­nounced in late September, are the secretary’s initial step in adopting the core elements.

The proposed regulations include solicitation of comments from the public on the draft core elements. Specifically, the secretary proposed adopting the federal sentencing guidelines’ “elements of an effective compliance and ethics program” as the basis for the core elements of the new, mandated Medicare and Medicaid compliance program.

The Table lists draft core elements of the proposed regulations; the language differs from actual language of the sentencing guidelines.

Previous Guidance on Physician Compliance Programs Although Obamacare imposes mandatory programs, the federal government has previously issued a number of pronouncements related to health care compliance efforts of providers. Obviously, the federal sentencing guidelines have long used the existence of an operating, effective compliance program as a factor supporting reduced punishment.

And, importantly, on Oct. 5, 2000, the Office of Inspector General of HHS officially announced a “compliance program for individual and smallgroup physician practices.” It is one of several guidance programs directed

at various segments of the health care industry, and continues to provide a relevant road map in compliance efforts.

The Obvious Choice Your Competitors Will Not Make Under nearly any scenario—other than a total repeal of Obamacare and no replacement legislation—it is nearly certain that mandatory requirements of compliance programs are here to stay.

Your competitors will almost certainly

regard compliance programs as “an aggravation” and a cost to be endured.

That viewpoint is entirely consistent with the fact that most anesMark F. Weiss, JD thesia groups, in fact most professional practices, are purely tactical (i.e., purely reactive) to business events: The

hospital indicates it has a problem with quality; what to do now? The administrator is thinking of issuing a request for proposal rather than directly entering into renewal negotiations with a group; what to do now?

However, the most successful groups are strategic. They have an overall business strategy, carry through with consistent substrategies and deploy coordinated implementing tactics.

Strategy is the filter through which see compliance page 50

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Today, Oridion Microstream® Capnography gives you that same confidence in monitoring your non-intubated patients.

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P A I N M E D I C I NE

Study Confirms High-frequency TENS Acts Through Opioid Receptors

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new study confirms that the analgesic effect of high-frequency transcutaneous electrical nerve stimulation can be reversed by low doses of naloxone—a result that challenges previous work.

The researchers found that the analgesic effect of TENS was maintained after

injecting saline or low doses of naloxone into healthy, young adults, but the action was blocked after injecting a high dose of the same agent. Thus, the investigators concluded that naloxone must block the µ, δ and κ-opioid receptors at high doses and only the µ-opioid receptors at low doses (Pain 2010;151:215-219.

The findings help explain why earlier studies in humans using low doses of naloxone showed the agent did not block the effects of high-frequency TENS. “The results of this study allow us to better understand the mechanisms of action of high-frequency TENS, hence providing the neurophysiologic

‘The results of this study allow us to better understand the mechanisms of action

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of high-frequency TENS, hence providing the neurophysiologic basis for its use in the clinic.’

—Guillaume Leonard, PhD basis for its use in the clinic,” said lead author Guillaume Leonard, PhD, postdoctoral research fellow at the University of Sherbrooke in Quebec, Canada.

“The results also suggest the existence of a possible interaction between TENS and opioids.”

Several studies from the 1970s and 1980s involving low-dose naloxone indicated that the analgesic function of high-frequency TENS could not be reversed by naloxone (see, e.g., Clin J Pain 1987;2:215-217). However, a team of researchers at the University of Iowa in Iowa City, subsequently found that high doses of naloxone blocked the µ, δ and κ-opioid receptors in rats and inhibited the pain-reducing effects of high-frequency TENS, whereas lowdose naloxone did not halt the action of TENS (J Pharmacol Exp Ther 2001;298:257-263).

To see if these outcomes translated to humans, lead investigator Serge Marchand, PhD, scientific director of the Étienne-Le Bel Clinical Research Centre at the University of Sherbrooke in Quebec and his colleagues randomized 21 healthy volunteers, mean age 25 years, in a triple-blind, crossover study. One-third of subjects received a low dose (0.02 mg/kg) of naloxone, another one-third received a high dose (0.14 mg/kg) and the remaining participants received saline.

To prepare, participants were shown how to navigate a computerized visual see TENS page 36

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AnesthesiologyNews.com I 35

Pa in Med ic ine

Perianal Local Anesthesia, Non-opioid Analgesics Optimal For Pain Management After Hemorrhoidal Surgery

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erianal local anesthetic infiltration and non-opioid analgesics are optimal for controlling postoperative pain following hemorrhoidal surgery, according to a new literature review.

“The findings confirm our current thinking that using local anesthetic infiltration and a combination of acetaminophen with NSAIDs [nonsteroidal anti-inflammatory drugs] or COX-2 [cyclooxygenase-2] inhibitors should be the first choice for pain management,” according to lead author Girish Joshi, MD, professor of anesthesiology and pain management at University of Texas Southwestern Medical Center, in Dallas.

The PROSPECT (Procedure Specific Postoperative Pain Management) study group conducted a systematic search of the EMBASE and Medline databases for randomized controlled trials from 1966 to June 2006 that reported pain interventions and outcome scores for adults who underwent hemorrhoidal surgery. Of 207 studies identified, 65 were included in the analysis. Recommendations for optimal pain relief were graded A through D, based on the level of evidence (LoE), determined by the quality of studies included and the consistency and source of evidence (Br J Surg 2010;97:1155-1168).

The eight studies that used peri­ anal local anesthetic infiltration documented significantly lower pain scores 24 hours after surgery according to visual analog scale (VAS) pain scores.

As a result, the authors recommended reducing postoperative pain by using long-acting local anesthetic infiltration for all patients undergoing hemorrhoidal surgery, either alone or with general or spinal anesthesia (grade A).

Although the choice of hemorrhoidal surgical techniques may depend on factors other than postoperative pain alone, the authors found that stapled hemorrhoidectomy significantly reduced pain compared with other surgical techniques (LoE 1). The authors suggested using this technique when appropriate (grade A).

Dr. Joshi’s team also concluded that the ease of administering perianal local anesthetic infiltration may make this intervention preferable to peripheral nerve blocks (grade D, LoE 4). However, they made no specific recommendations

regarding the choice of anesthetic technique (local, spinal, caudal epidural or general anesthesia) because of limited procedure-specific evidence.

To control postoperative pain pharmacologically, the authors suggested using non-opioid medications, such

as acetaminophen and conventional NSAIDs or COX-2–selective inhibitors as a first approach (grade B). Opioids may hinder a patient’s recovery because they can cause constipation.

Thus, even if non-opioids alone do not adequately control pain, they can

reduce the amount of opioids required.

Weak opioids should be used for low to moderate postoperative pain (VAS <50 mm), and strong opioids should be used for moderate to high levels of pain (VAS ≥50 mm). see local page 37

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P A I N M E D I C I NE

NSAIDs May Boost Stroke Risk Stockholm, Sweden—Any use of nonsteroidal anti-inflammatory drugs may increase the risk for stroke among healthy individuals, according to a study presented at the 2010 European Society of Cardiology Congress.

The increased risk was highest with diclofenac and lowest with ibuprofen, reported senior author, Gunnar Gislason, MD, from Gentofte University

Hospital, in Hellerup, Denmark. Dr. Gislason and his group previously reported that diclofenac and rofecoxib were associated with increased risk for cardiovascular death (coronary death or nonfatal myocardial infarction, and fatal or nonfatal stroke) in healthy Danes. The increased risk was dosedependent (Circ Cardiovas Qual Outcomes 2010;3:395-405).

In this study, Dr. Gislason and his team analyzed cerebrovascular risk. Of all 4,614,807 Danes aged 10 years or older on Jan. 1, 1997, 2,663,706 (57.8%) claimed at least one prescription for nonsteroidal anti-inflammatory drugs (NSAIDs) between 1997 and 2005.

After excluding patients hospitalized within the past five years or prescribed medications within the past two years, they were left with a cohort of 450,792 individuals deemed to be healthy.

Any use of NSAIDs was associated

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with increased risk for fatal or nonfatal stroke. The hazard ratio for ibuprofen was 1.28 (95% confidence interval [CI], 1.14-1.44); for naproxen, 1.35 (95% CI, 1.01-1.79); for rofecoxib, 1.61 (95% CI, 1.14-2.29); for celecoxib, 1.69 (95% CI, 1.11-2.26) and for diclofenac, 1.86 (95% CI, 1.58-2.19). As in the cardiovascular risk study, the increased risk was dose-dependent.

“NSAIDs affect the system in many different ways,” Dr. Fosbøl said. “The most frequent side effect is still gastrointestinal bleeding, which should be included in the decision chain when starting NSAID treatment.”

TENS continued from page 34 analog scale (VAS) to document the extent of pain they felt when subjecting a small area of the skin to a thermode that applied gradually increasing temperatures from 32 C to 51 C. When the study began, each subject was injected twice, with a high or low dose of naloxone or with saline.

The two injections were administered 35 minutes apart. The volunteers randomly rotated treatment arms after one week.

For each visit, TENS (100 Hz, 60 msec) was applied for 25 minutes to the surface of the left ankle. TENS intensity was adjusted to obtain strong but innocuous paresthesias. Participants recorded VAS scores in reaction to the thermode at four time intervals: baseline, 10 minutes after the second injection, five minutes before the end of a 25-minute TENS session initiated immediately after the second injection and 10 minutes after the end of the TENS session.

The investigators discovered that participants who received a naloxone injection in their first visit did not experience an analgesic effect from TENS in the subsequent visit when given saline because they had been conditioned to the pain. Because the order of presentation affected the results, only the first visits were analyzed and three more participants were added to increase the sample size.

The results revealed that subjects injected with saline and low-dose naloxone experienced a significant decrease in pain during and after applying TENS (P<0.001 and P<0.05, respectively). In contrast, after administering a high dose of naloxone, participants’ pain did not decrease significantly (P=0.2).

Mark Johnson, PhD, director of the Centre for Pain Research at Leeds

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Pa in Med ic ine Naproxen and low-dose ibuprofen show the most neutral cardiovascular safety profile, he added. “However, the risk for upper gastric bleeding should always be incorporated in the decision.”

Dr. Fosbøl agreed that the dangers posed by NSAID use are a public health problem. “NSAIDs are sold OTC [over the counter] in many countries and the general perception is they are not harmful.” However, based on the current data, “some NSAIDs are not suited for OTC sales [even at lower doses], and those sales should be re-evaluated.”

Metropolitan University in the United Kingdom, said this was a high-quality study and the researchers provided a compelling “explanation for the failure to detect opioid involvement in previous human studies.” Additionally, noted Dr. Johnson, the observed pain conditioning suggests “if a patient receives TENS and the setting or electrode positions are not effective during the first treatment, it is going to be more difficult to improve the effectiveness by modifying the setting or positions on subsequent TENS treatments.”

—Rosemary Frei, MSc

Local continued from page 35 The authors found insufficient evidence to prefer one particular non-opioid, and recommended that individual patient risk factors, such as ulcer history, cardiovascular morbidity, bleeding and renal and hepatic function complications determine the choice of treatment (grade B).

Other medications recommended as analgesic adjuncts include laxatives (grade A, LoE 1) and oral metronidazole (grade A, LoE 1) started before surgery. Stool softeners were an alternative to laxatives in clinical practice (grade D, LoE 4).

The review “could serve as a great resource for surgeons who perform ambulatory anorectal surgery,” said Janice F. Rafferty, MD, chief of colon and rectal surgery at the University of Cincinnati. “I already do many of the things recommended here, but this could certainly change the practice of surgeons who would like to update their care of patients with anorectal disease.”

—Shayna Kravetz

Pharmacists’ Perspective Amy Seybert, PharmD, interim department chair and associate professor, University of Pittsburgh Medical Center, said the new NSAID study data are limited with regard to selection criteria, other medications and comorbidities in the Danish population, which makes it difficult to draw definitive conclusions for the population in the United States.

“But, the authors accurately conclude there is a need for more awareness of the risks of NSAIDs,” she said.

C. Michael White, PharmD, professor of pharmacy at the University of Connecticut, in Storrs, said that he would have liked to see a numberneeded-to-harm calculation. “While the risk in a healthy person might be increased markedly by NSAID use, if 10 million people have to be treated for five years to get one event, then the risk to society is very modest. However, if only 200 people need to be treated, we have an important public health issue.”

Pharmacists should have a conversation with patients who are taking chronic NSAIDs about the potential heart and brain risks so patients can make informed choices, he added.

“Acetaminophen is heart (and likely brain) risk-neutral and even if you can’t avoid having to take an NSAID every now and again, decreasing the intensity of NSAID dosing or avoiding it from time to time is likely worthwhile.”

—Fran Lowry

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Efforts To Document the “Fifth Vital Sign” Growing Abroad

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fter a hospital-wide educational campaign, staff at West Suffolk Hospital in the United Kingdom exhibited significant improvements in awareness and assessment of pain as the fifth vital sign, according to a study presented at the 2010 World Congress on Pain. After the staff training, patients’ use of the pain assessment tool almost doubled (PW 133).

“There’s a growing awareness in the U.K. that it’s important to assess pain alongside the four basic vital signs— blood pressure, pulse, respiration and temperature—but we haven’t been successful in promoting and implementing this practice,” said study author Christine Waters, MD, pain management nurse specialist in the Department of Pain Medicine at West Suffolk

Hospital in Edmunds. “I feel a professional and ethical obligation to improve the patient experience and pain management.”

Beverly Collett, MBBS, assistant medical director of the Pain Management Service at the University Hospitals of Leicester, England, added, “We are way behind [the United States],” where pain is evaluated as the fifth vital sign in

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every hospital. “In U.K. hospitals, pain scores are done routinely for postoperative pain, but not for chronic pain and rarely for acute pain,” noted Dr. Collett, who was not involved in the research.

In 2004, researchers from the University of Dundee and the University of St. Andrews, in Dundee, Scotland, published the results of a national survey of acute pain services in 325 hospitals and found significant deficits in acute pain management (Br J Anaesth 2004;92:689-693). For example, 30% of respondents described their acute pain service as “thriving,” whereas 52% indicated that service was “struggling to manage” and 17% said it was nonexistent or played only a minor role.

In addition, a majority of respondents agreed that postoperative pain services often were confused and unstructured (59%).

In 2006, members of the British Pain Society, physicians and nurses formed the UK Chronic Pain Policy Coalition to help improve pain management in hospitals by routinely recording pain as the “fifth vital sign.” In 2009, England’s chief medical officer came on board in support of this proposal.

To ensure the recommendation was put into practice, Dr. Waters and her colleagues launched an educational and awareness campaign to help implement this standard and to improve patients’ understanding of the pain scoring tool.

“Our goal was to see if we could change the behavior of nurses and other health care professionals in just six months,” Dr. Waters said. “We are making the assumption that improved pain documentation will lead to improved pain management and prevent the effects of untreated pain.”

First, the team came up with four audit indicators: 1) patients would state that the pain scoring tool was explained in a manner they could understand; 2) pain scores would be documented on the observation chart as the fifth vital sign; 3) staff would be trained and confident in the use of the pain assessment tool; and 4) staff would be aware of the minimum frequency of pain assessment.

Before the campaign, the investigators conducted a hospital-wide audit, reviewing data from observational charts and patients’ verbal reports from 2009 to 2010, and found significant variations in compliance with the four indicators across three departments: surgery and orthopedics, general medicine and emergency assessment unit.

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Pa in Med ic ine

FDA OKs Ofirmev, IV Acetaminophen

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Based on the results of this initial analysis, documenting pain scores alongside the standard vital signs became a key performance indicator for the hospital.

Subsequently, Dr. Waters and her team coordinated the hospital-wide educational campaign, teaching all nurses and health care professionals in the three departments about pain, why it is important to assess it and how to do so using simple tools, including the standard pain scale (range, 0-10). Seventy patients and 70 staff members were recruited to participate, and data were collected every three months for six months.

After the training, the number of staff trained in pain assessment rose from 76% to 90%, and staff awareness of pain scoring improved from 81% to 97%.

In six months, pain documentation increased markedly, from 40% to 72%.

The second audit indicator (documentation of pain scores on the observation chart as the fifth vital sign) showed the greatest changes from pre- to post-training. Pain score documentation improved from 69.5% to 84% in the surgery and orthopedics department, from 1% to 66% in general medicine and from 1.4% to 57% in the emergency assessment unit. Additionally, significantly more patients reported understanding the pain assessment tool after staff training (increasing from 36% to 63%).

In view of the positive outcomes of the campaign, “I hope other hospitals will adopt this approach to improve patient experience,” Dr. Collett said.

Dr. Waters agreed that other hospitals would benefit from educating and training hospital staff about the importance of documenting and managing pain in patients and making it a quality indicator for hospitals.

“We would like this campaign to translate into routine care,” she said.

“Although there are limitations to using a simple tool for documenting a patient’s experience of persistent pain, at least this is a step toward identifying and fixing the problem [of inadequate pain management].”

—Victoria Stern

he FDA has approved Ofirmev, the first IV form of acetaminophen available in the United States, for the treatment of pain and fever in both adults and children.

The drug, from Cadence Pharmaceuticals, is indicated for the management of mild to moderate pain; management of moderate to severe pain when prescribed with opioids; and as a fever reducer.

The FDA based its approval on results from clinical trials involving 1,020 adults and 355 children who received the drug, which is administered as a 15-minute

IV infusion. Patients in the pain studies underwent orthopedic or laparoscopic abdominal surgeries. Those who received IV acetaminophen experienced statistically reduced pain and consumed less morphine than did those given a placebo.

For the fever study, adults with an induced fever received a single, 1-g dose of the drug or a placebo and were monitored for six hours.

Cadence said it expects to launch Ofirmev in early 2011.

—AN Staff

CONTINUING MEDICAL EDUCATION

deCeMBer 2010

Lesson 289: PeriAnesthetic Management Of the Ex-Premature Infant WRITTEN BY:

LEARNING OBJECTIVES

Donald A. Schwartz, MD Chief of pediatric anesthesia, Department of Anesthesiology, Baystate Medical Center, Springfield, Massachusetts

At the end of this activity, the participant should be able to: 1. Summarize the unique pathologic conditions in the ex-premature infant.

2. Describe the impact of these conditions on the delivery of anesthesia.

3. List possible anesthetic options for the ex-premature infant.

4. Recognize the possible complications of caudal anesthesia.

5. Develop an anesthetic plan for an ex-premature infant.

6. List the pros and cons of anesthetic plans in these cases.

7. Recognize the signs and symptoms of local anesthetic toxicity.

8. Anticipate postoperative complications in the ex-premature infant.

9. Prescribe appropriate monitoring.

10. Identify steps of advanced life support in pediatric cases.

REVIEWED BY: Elizabeth A.M. Frost, MD Clinical professor, Department of Anesthesia, Mount Sinai Medical Center, New York, New York

DATE REVIEWED: November 2010 DISCLOSURES The author and reviewer have no relationships with pharmaceutical companies or manufacturers of products to disclose. This educational activity may contain discussion of published and/ or investigational uses of agents for the treatment of disease. Some uses of these agents have not been approved by the FDA. Please refer to the official prescribing information for each product for approved indications, contraindications, and warnings.

NEEDS STATEMENT As the management of premature infants improves, more children survive until such time that elective procedures can be undertaken. Anesthesiologists may be called on to care for these children. An understanding of the altered physiology of these patients has been identified by committee as required knowledge for anesthesia practitioners.

CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an e-mail to Elizabeth A.M. Frost, MD, at ElzFrost@aol.com.

TARGET AUDIENCE Anesthesiologists

CASE HISTORY A 4-month-old boy, born prematurely at 28 weeks of gestation, was admitted for surgical repair of bilateral inguinal hernias and circumcision. The infant had been hospitalized in the neonatal intensive care unit for the first 3 months of life. His symptoms included respiratory distress syndrome, and bronchopulmonary dysplasia for which he required assisted ventilation. The infant was discharged to home, and received oxygen by nasal cannula until 2 weeks before the surgery. His medical history included additional problems related to prematurity—eg, grade 1 (mild) intraventricular hemorrhage, a patent ductus arteriosus (which was treated medically and subsequently closed), and mild retinopathy.

On examination of the infant in the preoperative holding area, he appeared to be vigorous; he weighed 5 kg, his heart rate was 137 beats per minute, oxygen saturation on room air was 96%, and respiratory rate was 40 breaths per minute. Breath sounds were clear on auscultation. No laboratory tests were ordered preoperatively. Hematocrit level was 29% at the time of discharge from the hospital 4 weeks previously. The decision was made to proceed with a spinal anesthetic, and parental consent was obtained.

A

lthough not as stressful for the anesthesiologist as a premature infant in the neonatal intensive care unit (ICU) who requires emergency surgery, the ex-premature patient presents multiple challenges. Premature infants, because of surfactant deficiency, may develop neonatal respiratory distress syndrome or hyaline membrane disease very early in the postnatal period. Supplemental oxygen and barotrauma from mechanical ventilation can lead to bronchopulmonary dysplasia (BPD)—a destructive and chronic form of lung disease that can take months or even years to fully resolve. As a result, the ex-premature infant may require supplemental oxygen several months after discharge.

More severe BPD may result in pulmonary hypertension, fluid retention, fibrosis, and wheezing, for which diuretics and bronchodilators may be prescribed. When intubating an infant with BPD, one should anticipate the same set of problems encountered in any patient with chronic lung disease: induced bronchospasm, episodes of desaturation, and possible postoperative ventilation.

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine in New York City. She is the author of Clinical Anesthesia in Neurosurgery (ButterworthHeinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City).

A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson post-test and course evaluation before December 31, 2011. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit.

TIME TO COMPLETE ACTIVITY: 2 hours RELEASE DATE: December 2010 TERMINATION DATE: December 31, 2011 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The biggest anesthetic challenge—after chronic lung disease—is the threat of postoperative apnea and bradycardia. Apnea (defined as a cessation of breathing for >20 seconds) is due to immaturity of the respiratory regulatory centers in the brainstem or is secondary to a disease process elsewhere (sepsis, anemia, etc). Apnea generally leads to hypoxemia and then bradycardia because of the predominance of parasympathetic stimulation of the neonatal heart during times of stress. Premature infants eventually outgrow episodes of apnea, but apnea may still be an active problem at the time of outpatient surgery.

Most anesthetics (inhalation agents, opioids, sedatives, induction agents) can worsen the risk for apnea; also, apnea that has resolved may reappear, or it may be induced for the first time. The infant’s risk for apnea after general anesthesia depends on postconceptual age (PCA)—the greater the PCA, the lower the risk. Several studies have looked at the PCA at which outpatient surgery is considered safe and apnea-free.1 The most conservative view holds that

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits.™ Physicians should only claim credit commensurate with the extent of their participation in the activity.

It is the policy of Mount Sinai School of Medicine to ensure objectivity, balance, independence, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices.

41

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CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

deCeMBer 2010

which a caudally threaded epidural catheter is preceded by a single-shot caudal block.20 Another option is the sacral interspinous approach to the caudal space, although the risk for dural puncture increases.21 General anesthesia is reserved as a backup whenever regional anesthesia is planned in an infant. Technical difficulties in administering a spinal or caudal anesthetic in an awake infant are real, and mandate discussion with parents prior to surgery. A caudal block is an adjunct to general anesthesia in all pediatric patients which can reduce perioperative requirements for opioids—useful in the ex-premature infant given that perioperative opioids can lead to postoperative apnea.

Figure 1. Arrows point to the sacral cornua which cast a characteristic shadow downward (the “two nuns”). The sacrococcygeal ligament runs between them.

From reference 22. Copyright © 2008, Wolters Kluwer Health.

All rights reserved.

Figure 3. Injectate within the canal using the Doppler mode. An injection not in the caudal canal would be seen as dilation to the right or left of the sacral apex (white arrow). Detection using ultrasound is quicker than using palpation.

From reference 22. Copyright © 2008, Wolters Kluwer Health.

All rights reserved.

may cause apnea due to loss of accessory muscle action, but this generally occurs immediately after placement.

Recent reports of neurotoxicity in neonatal animals exposed to general anesthetics9 may prompt some to avoid these agents in favor of regional techniques in human infants. Although there are published reports that caution about anesthetic exposure and learning disabilities in children,10,11 there is as yet no definitive evidence that regional anesthesia results in less neuropathology.

Figure 2. An ultrasound image obtained with the probe further cephalad over the sacrum indicates the sacral canal (white arrow) in cross section. Turbulence and dilation with each injection verifies that local anesthetic is being placed within the caudal canal.

From reference 22. Copyright © 2008, Wolters Kluwer Health.

All rights reserved.

a 60-week PCA is preferred,2 whereas others make the case that 45 to 50 weeks is adequate.3 Infants in whom PCA is below a predetermined threshold should be admitted for overnight monitoring.

In the past, a hematocrit level maintained near 30%, and transfusions and the administration of a central stimulant such as caffeine, were strategies believed to prevent postoperative apnea.4 It is hard to justify transfusion therapy with its attendant risks, particularly when intraoperative blood loss is not anticipated to be high. If an infant is receiving a methylxanthine, it makes sense to continue it throughout the perioperative period. However, prophylactic caffeine or theophylline in an infant who is not already receiving it should be administered with caution.

Choice of Anesthetic Technique Because of possible preexisting lung disease and the risk for postoperative apnea in the ex-premature infant, regional anesthesia (spinal, caudal) is an attractive alternative to general anesthesia.5 Studies have shown that regional anesthesia leads to less apnea and fewer other postoperative complications.6,7 However, an infant may develop postoperative apnea if sedatives are administered during regional procedures.8 Also, spinal anesthesia itself

Neuraxial Techniques in the Ex-Premature Infant Spinal anesthesia has a long record of safety and effectiveness in infants, including premature and ex-premature infants.12,13 Spinal techniques typically are used to provide anesthesia in subumbilical surgery, but its use for procedures above the umbilicus also has been described.14 A single-shot spinal with either 1% tetracaine or 0.5% bupivacaine with epinephrine 1:200,000 (0.5-1.0 mg/kg) reliably yields a mid-thoracic sensory level with little or no hemodynamic compromise for up to 2 hours. The spinal cord descends to L1-2 in the neonate; thus, attempts to administer spinal anesthesia should be below this level. The periosteum of the neonatal vertebra bleeds very easily and “bloody taps” therefore are not uncommon. The failure rate for single-shot spinals in infants is between 10% and 20%.5 Caudal anesthesia as the sole anesthetic technique in the ex-premature infant is a reasonable alternative in the event of a failed spinal, or as a first-line technique. A singleshot caudal requires the injection of a larger volume of local anesthetic (0.7-1 mL/kg) for inguinal anesthesia. Caudal anesthesia as the sole anesthetic for supra-umbilical surgery in critically ill premature infants has been described.15 One advantage of caudal anesthesia over spinal anesthesia is the ability to redose by keeping an angiocatheter in place through the sacral hiatus, or by threading an epidural catheter into the sacral canal or higher into the lumbar or thoracic spine.16,17 A recent retrospective comparison of spinal and caudal blocks in awake ex-premature infants found that caudals were technically easier to perform, and required fewer attempts than the subarachnoid approach.18 A combined spinal–epidural technique is an option that entails the placement of a spinal block initially, followed by a caudally threaded epidural catheter for long procedures above and below the umbilicus.19 A combined caudal–epidural technique also has been described, in

Technical Aspects of Caudal Anesthesia in Infants: Ultrasound and Needle Selection A successful caudal block depends on accurate identification of the sacral hiatus, the distal opening in the sacrum that is covered by skin and the sacrococcygeal ligament.

Palpation of the area usually suffices, but can be inaccurate and difficult in some infants because of anatomic variation.

Portable ultrasonography is a valuable tool for correctly identifying sacral anatomy and “visualizing” local anesthetic as it is injected into the sacral canal.22 First described by Roberts et al for use in the longitudinal plane,23 ultrasound also can be used for this purpose in the transverse plane. One looks for turbulence and dilation within the sacrum or changes in a Doppler signal (Figures 1-3). Holding the ultrasound probe over the sacral hiatus can help identify the correct caudal needle placement.

Ultrasound is more reliable than other methods for confirming correct needle placement within the caudal canal24 and can be used to locate the tip of an epidural catheter if one is threaded up from the caudal space (Figures 4 and 5).

Opinions vary as to which needle is optimal for caudal placement. Styletted spinal needles reduce the theoretical migration of mitotic epidermal cells into the sacral canal.

Blunt-tipped regional needles increase tactile “feel” and theoretical safety against intravascular injection. Other anesthesiologists (the author included) use angiocatheters because it is difficult to smoothly advance the catheter over the needle unless it is placed correctly in the caudal canal. Long beveled hypodermic needles should be used with extreme caution, as accidental placement into the soft back wall of the sacrum may result in negative aspiration of blood, little resistance to injection, and intravascular toxicity.

Regardless of the needle used, injection of local anesthetic should only follow a negative aspiration for blood and cerebrospinal fluid (CSF), and be slow and incremental with electrocardiographic (EKG) monitoring.25 Epinephrine included in the injectate provides additional safety by inducing early tachycardia if the injection is intravascular.

Cardiac Toxicity of Local Anesthetics In Infants Local anesthetics are more toxic in infants than in older children and adults due primarily to decreased protein binding in infants, thus generating a greater fraction of free (unbound) drug. The prolonged elimination of local-anesthetic amide compounds because of immature hepatic enzyme systems also contributes to increased toxicity in infants.

Of the available local anesthetics, bupivacaine, a long-acting amide, has the longest track record, clinically. Bupivacaine produces a reliable block when given caudally, but its major drawback is cardiac toxicity when given inadvertently as an intravascular bolus. The slow reversibility of its binding to sodium channels in the heart causes conduction delay and arrhythmias from escape pathways. Bupivacaine also is a direct myocardial depressant. It may produce severe arrhythmias and ventricular fibrillation after rapid IV administration; cardiac resuscitation may be very difficult.

CONTINUING MEDICAL EDUCATION

deCeMBer 2010

Figure 4. The tip of a caudally threaded thoracic epidural catheter is shown in the longitudinal plane.

From reference 20. Copyright © 2010, Elsevier. All rights reserved.

Figure 5. The tip of the catheter is shown in cross-section.

Schwartz D, King A. Caudally threaded thoracic epidural catheter as the sole anesthetic in a premature infant and ultrasound confirmation of the catheter tip. Paediatr Anaesth. 2009;19(8): 808-810. Copyright © 2009, Blackwell. All rights reserved.

and organized. Help should be summoned. Initiation of cardiovascular and ventilatory support with cardiopulmonary resuscitation (CPR) is the first step, as outlined in the pediatric advanced life support (PALS) manual of the American Academy of Pediatrics and American Heart Association.28,29 In general, 2-rescuer CPR with a compression-to-ventilation ratio of 15:2 should begin (heart rate of 100 bpm). The infant’s trachea is already intubated, so 8 to 10 breaths per minute should be provided without pause for chest compressions. This ratio emphasizes chest compressions with blood flow to the coronary and cerebral vasculature over ventilation. Excessive ventilation during resuscitation can impede venous return and cardiac output. All inhalation anesthetics should be discontinued because they cause myocardial depression and vasodilatation.

The PALS algorithm for pediatric pulseless arrest (Table) should be followed—in this case, the arm for shockable rhythms, ventricular tachycardia/ventricular fibrillation (VT/VF). The algorithm is designed to provide periods of effective, uninterrupted CPR with efficient delivery of electrical therapy. An initial asynchronous shock of 2 J/kg is followed by immediate resumption of CPR if a stable rhythm is not observed. The shorter the interval between the last compression and the shock delivery, the greater the probability of shock success.

A shock of 4 J/kg is followed by approximately 2 minutes of CPR and the administration of IV epinephrine, 0.01 mg/kg (0.1 mL/kg=1:10,000). Rhythm should be assessed—these interruptions should last no longer than 10 seconds—and chest compressions should be resumed. A third shock should be administered (4 J/kg), followed by continuous CPR. If VT/VF persists, an antiarrhythmic drug such as amiodarone (Vaughan-Williams class III; 5 mg/kg) should be considered. Alternatives include lidocaine (1 mg/kg) and magnesium sulfate (25-50 mg/kg), with the latter indicated for VF with torsades de pointes.

Since 2006, reports have been published of lipid emulsion therapy for local anesthetic toxicity. To date, there are

Table. PALS Algorithm for Pulseless VT/VF Initiate CPR The maximum dose of bupivacaine that should be administered in a pediatric caudal block is 2.5 mg/mL (1 mL/kg of 0.25% solution). By comparison, ropivacaine—another longacting amide that consists of an L-enantiomer—has a shorter plasma half-life and less lipid solubility than bupivacaine.

Ropivacaine is an effective agent for pediatric caudal anesthesia with equivalent sensory block—but less motor block— than bupivacaine. The decreased cardiac toxicity associated with ropivacaine is balanced against its slightly decreased anesthetic potency. Cardiac toxicity in an infant following a caudal block with ropivacaine has recently been described.26 L--bupivacaine (ie, containing only the L--enantiomer) has the best safety profile for cardiac toxicity of the long-acting, local-anesthetic amides. When used for caudal blocks in children, it has been shown to be as effective as bupivacaine.27 Unfortunately, it is not yet available in the United States.

Although no definitive data have been published regarding a reasonable period of time to redose after a single caudal block, in the author’s practice the wait is at least 3 hours, based on the half-life of bupivacaine; a dose half as concentrated as the first (eg, 0.125% bupivacaine) is then administered.

Treatment of Cardiac Toxicity From Local Anesthetics In the event of an intravascular bolus of local anesthetic with cardiac decompensation, treatment must be prompt

Defibrillation, 2 J/kg Reinitiate CPR Repeat defibrillation if rhythm is still unstable; increase J setting to 4 J/kg Reinitiate CPR Check rhythm; if still in VT/VF, administer medication Epinephrine (1:10,000), 0.01 mg/kg IV; may be repeated every 3-5 minutes Repeat defibrillation if still unsuccessful (4 J/kg) Reinitiate CPR Check rhythm; if still in VT/VF, administer medication Amiodarone, 5 mg/kg IV bolus, or

Lidocaine, 1 mg/kg IV,

or

Magnesium, 25-50 mg/kg IV (for torsades de pointes)

Repeat defibrillation/CPR/epinephrine, if still unsuccessful Based on reference 28.

CPR, cardiopulmonary resuscitation; IV, intravenous; J, joule; PALS, Pediatric Advanced Life Support; VF, ventricular fibrillation; VT, ventricular tachycardia

Figure 6. Electrocardiogram showing wide sinusoidal rhythm and tachycardia.

numerous case reports of successful resuscitation following intralipid administration, including one in an infant who received a caudal block.30 These reports follow many years of animal research that showed the beneficial resuscitative effects of intralipids after infusion of local anesthetics. Currently, the recommendation for local anesthetic–induced cardiac arrest is conventional resuscitative therapy; if that proves unsuccessful, intralipid 20% (1-2 mL/kg for 1 minute) is administered, followed by an infusion at a rate of 0.25 mL/kg per minute. The bolus can be repeated every 3 to 5 minutes, up to a dose of 3 mL/kg, and the infusion increased to 0.5 mL/kg per minute. Further studies will no doubt clarify the role of intralipids in toxin-induced resuscitations; meanwhile, a supply of intralipid should be readily available anytime regional blocks, including caudals, are performed.

Safety of Caudal Blocks in Infants Caudal blocks in children are generally very safe, with a very low incidence of serious complications.31 Most serious complications develop in infants less than 6 months old.

The keys to safe caudal administration in infants include correct anatomic localization, avoidance of sharp beveled needles, safe dosages of local anesthetic, and slow incremental injection while monitoring the EKG. The use of ultrasound to define anatomy and verify placement also can increase the overall safety of the procedure.

Management of the Case Presented A peripheral IV cannula was placed. The patient’s back was cleansed, and lidocaine 1% was injected in the skin above the L4-5 interspace. Because of the infant’s movement and difficulty with his positioning, 0.1 mg of midazolam was administered twice. The infant became calmer, but after multiple passes with a short 22-gauge spinal needle, blood was obtained each time. The infant was positioned upright, but the result was the same and the technique was abandoned.

General anesthesia with a caudal block was planned.

Endotracheal intubation with a 3.5-mm endotracheal tube was achieved after administration of 10 mg of propofol and 5 mg of rocuronium. The infant was placed in the left lateral position, and the sacral hiatus located by palpation. Several passes were made with a 21-gauge long beveled needle.

After a negative aspiration for blood and CSF, 5 mL of bupivacaine 0.25% was injected.

After completion of the caudal block, the infant was repositioned and surgery commenced. No changes in vital signs were noted at the time of incision. The surgery proceeded uneventfully. Throughout the procedure, a 2-L flow of sevoflurane 1% in an oxygen-nitrous oxide mixture of 50% was maintained. No opioids were administered. Surgical repair was slow and difficult. After 2.5 hours the patient’s heart rate increased slightly from 130 to 145 bpm, which was treated by increasing the sevoflurane concentration to 2%.

Surgery lasted 3 hours. Plans were made for the infant to stay overnight in a monitored pediatric ICU/step-down unit.

After surgery, preparations were made for a second caudal block. The infant was again placed in the left lateral position, still intubated and mechanically ventilated. Injection of another 5 mL of bupivacaine 0.25% was begun.

43

44

CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

The infant was placed supine, but perfusion appeared to be poor with mottling in all extremities. EKG showed a wide, complex sinusoidal rhythm at 220 bpm (Figure 6). Capnometry revealed an end-tidal CO2 concentration of 15 torr.

Pulse oximetry and noninvasive blood pressure measurements were not registering.

CPR was initiated. Sevoflurane and nitrous oxide were discontinued. Asynchronous defibrillation was attempted 3 times in rapid succession in doses of 2 J/kg (10 J), 4 J/kg (20 J), and 4 J/kg. The rhythm remained unchanged. Epinephrine 0.5 mL (1:10,000) was administered. Another attempt at defibrillation was unsuccessful. Subsequently, a 5-mg/kg dose of amiodarone was administered. Defibrillation with 20 J resulted in a sinus rhythm at a rate of 110 with return of pulses and improved perfusion. Because local anesthetic toxicity was highly suspected, 5 cc of 20% intralipid was infused for 1 minute, followed by an infusion at 0.25 mL/kg per minute. The infant’s vital signs were stable, and he was taken to the pediatric ICU. Later that day, he was extubated, and he was discharged home the following day. A follow-up examination revealed no sequelae.

References 1.

Coté CJ, Zaslavsky A, Downes JJ, et al. Postoperative apnea in former preterm infants after inguinal herniorrhaphy: a combined analysis.

Anesthesiology. 1995;82(4):809-822.

2.

Kurth CD, Spitzer AR, Broennie AM, Downes JJ. Postoperative apnea in preterm infants. Anesthesiology. 1987;66(4):483-488.

3.

Walther-Larsen S, Rasmussen LS. The former preterm infant and risk of postoperative apnoea: recommendations for management. Acta Anaesthesiol Scand.

2006;50(7):888-893.

deCeMBer 2010

17. Bösenberg AT, Bland BA, Schulte-Steinberg O, Downing JW. Thoracic epidural anesthesia via caudal route in infants. Anesthesiology. 1988;69(2):265-269.

18. Hoelzle M, Weiss M, Dillier C, Gerber A. Comparison of awake spinal with awake caudal anesthesia in preterm and ex-preterm infants for herniotomy. Paediatr Anaesth. 2010;20(7):620-624.

19. Somri M, Tome R, Yanovski B, et al. Combined spinal-epidural anesthesia in major abdominal surgery in high-risk neonates and infants. Paediatr Anaesth.

2007;17(11):1059-1065.

20. Schwartz DA, Patel D, Connelly NR. Caudally threaded epidural catheter following a single-shot caudal block in a high-risk neonate: a combined caudal-epidural technique. J Clin Anesth. 2010;22(4):305-307.

4.

Welborn LG, Greenspun JC. Anesthesia and apnea: perioperative considerations in the former preterm infant. Pediatr Clin North Am. 1994;41(1):181-198.

5.

Broadman LM. Use of spinal or continuous caudal anesthesia for inguinal hernia repair in premature infants: are there advantages? Reg Anesth. 1996; 21(6 suppl):108-113.

21. Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009;111(5):1135-1140.

6.

Somri M, Gaitini L, Vaida S, Collins G, Sabo E, Mogilner G. Postoperative outcome in high-risk infants undergoing herniorrhaphy: comparison between spinal and general anaesthesia. Anaesthesia. 1998;53(8):762-766.

22. Schwartz D, Raghunathan K, Dunn S, Connelly NR. Ultrasonography and pediatric caudals. Anesth Analg. 2008;106(1):97-99.

7.

Krane EJ, Haberkern CM, Jacobson LE. Postoperative apnea, bradycardia, and oxygen desaturation in formerly premature infants: prospective comparison of spinal and general anesthesia. Anesth Analg. 1995;80(1):7-13.

8.

Welborn LG, Rice LJ, Hannallah RS, Broadman LM, Ruttimann UE, Fink R. Postoperative apnea in former preterm infants: prospective comparison of spinal and general anesthesia. Anesthesiology. 1990;72(5):838-842.

Conclusion

9.

Creeley CE, Olney JW. The young: neuroapoptosis induced by anesthetics and what to do about it. Anesth Analg. 2010;110(2):442-448.

As a patient, the ex-premature infant presents numerous challenges. Persistent risks for apnea and residual lung disease are major concerns. Regional anesthesia is a good choice for outpatient infra-umbilical surgery because it avoids many of the potential risks associated with general anesthesia. Regional anesthesia options are many; spinal and caudal techniques are preferred, but caudal block in combination with a general anesthetic can reduce the need for opioids and muscle relaxants. Factors that can increase the safety of caudal blocks in infants include the use of ultrasound, avoidance of beveled needles, safe dosing of local anesthetics, and slow, incremental injections.

All pediatric anesthesiologists should follow the PALS algorithm in the event that an inadvertent intravascular injection of local anesthetic leads to cardiac toxicity. The use of intralipid 20% as an antidote has shown promise.

10. Wilder RT, Flick RP, Sprung J, et al. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009;110(4):796-804.

11. Kalkman CJ, Peelen L, Moons KG, et al. Behavior and development in children and age at the time of first anesthetic exposure. Anesthesiology. 2009;110(4):805-812.

12. Williams RK, Adams DC, Aladjem EV, et al. The safety and efficacy of spinal anesthesia for surgery in infants: the Vermont Infant Spinal Registry. Anesth Analg.

2006;102(1):67-71.

13. Shenkman Z, Hoppenstein D, Litmanowitz I, et al. Spinal anesthesia in 62 premature, former-premature or young infants: technical aspects and pitfalls.

Can J Anesth. 2002;49(3):262-269.

23. Roberts SA, Guruswamy V, Galvez I. Caudal injectate can be reliably imaged using portable ultrasound: a preliminary study. Paediatr Anaesth. 2005;15(11):948-952.

24. Raghunathan K, Schwartz D, Connelly NR. Determining the accuracy of caudal needle placement in children: a comparison of the swoosh test and ultrasonography. Paediatr Anaesth. 2008;18(7):606-612.

25. Tobias JD. Caudal epidural block: a review of test dosing and recognition of systemic injection in children. Anesth Analg. 2001;93(5):1156-1161.

26. Hübler M, Gäbler R, Ehm B, Oertel R, Gama de Abreu M, Koch T. Successful resuscitation following ropivacaine-induced systemic toxicity in a neonate.

Anaesthesia. 2010;65(11):1137-1140.

27. Frawley GP, Downie S, Huang GH. Levobupivacaine caudal anesthesia in children: a randomized double-blind comparison with bupivacaine.

Paediatr Anaesth. 2006;16(7):754-760.

28. Pediatric Advanced Life Support Course Guide and PALS Provider Manual.

Ralston M, Hazinski MF, Zaritsky AL, Schexnayder SM, Kleinman ME, eds.

American Academy of Pediatrics and American Heart Association; 2006.

ISBN 0-87493-527-X and 0-87493-528-8.

14. Somri M, Gaitini LA, Vaida SJ, et al. The effectiveness and safety of spinal anaesthesia in the pyloromyotomy procedure. Paediatr Anaesth. 2003;13(1):32-37.

29. Kleinman ME, Chameides L, Schexnayder SM, et al. Part 14: Pediatric advanced life support: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2010; 122(18 suppl 3):S876-S908.

15. Cucchiaro G, DeLagausie P, El-Ghonemi A, Nivoche Y. Single-dose caudal anesthesia for major intraabdominal operations in high-risk infants. Anesth Analg.

2001;92(6):1439-1441.

30. Shah S, Gopalakrishnan S, Apuya J, Shah S, Martin T. Use of intralipid in an infant with impending cardiovascular collapse due to local anesthetic toxicity. J Anesth.

2009;23(3):439-441.

16. Peutrell JM, Hughes DG. Epidural anaesthesia through caudal catheters for inguinal herniotomies in awake ex-premature babies. Anaesthesia. 1993;48(2):128-131.

31. Veyckemans F, Van Obbergh LJ, Gouverneur JM. Lessons from 1,100 pediatric caudal blocks in a teaching hospital. Reg Anesth. 1992;17(3):119-125.

Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the Web site, call toll-free customer service at (888) 345-6788 or send an e-mail to Customer.Support@ProCEO.com.

For inquiries about course content only, send an e-mail to ram.roth@mssm.edu.

Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Mount Sinai School of Medicine, New York, NY.

Post-Test 1. All of the following needles are acceptable for caudal blocks in infants, except: a. b. c. d.

20-gauge angiocatheter styletted spinal 21-gauge beveled hypodermic 22-gauge angiocatheter

2. The most likely reason that an ex-premature infant would require supplemental oxygen is: a. b. c. d.

bronchopulmonary dysplasia apnea of prematurity hyaline membrane disease surfactant deficiency

3. Which statement is false regarding postoperative apnea in the ex-premature infant? a. Apnea will not develop in a patient who did not have it prior to surgery. b. Transfusing to a hematocrit level of 30% may prevent apnea. c. Postoperative apnea is less likely to develop in an infant of 58 weeks postconceptual age than in one of 40 weeks postconceptual age. d. Methylxanthines have been shown to help prevent apnea.

4. Which statement is true regarding the use of ultrasonography when performing a caudal block in infants? a. Ultrasound can only be used in the transverse plane. b. Injectate can be seen in the sacral canal when using the Doppler mode. c. Needle identification is key when using ultrasound during caudals. d. It is difficult to identify the sacral hiatus by an ultrasound examination.

5. When administering a caudal block with 0.25% bupivacaine in an infant: a. b. c. d.

2 mL/kg is a safe dose the solution contains only an L-enantiomer 1 mL/kg should not be exceeded the total volume can be administered quickly

6. In the event of pulseless ventricular tachycardia following the administration of local anesthetic: a. a bolus of intralipid should be the first intervention b. cardiopulmonary resuscitation should be administered, followed by asynchronous shocks of 1 J/kg

c. amiodarone should be administered before epinephrine d. a bolus of 1 to 2 mL/kg of 20% intralipid should be given if conventional resuscitation is not successful

7. Which of the following is a true statement about regional anesthesia in ex-premature infants? a. A spinal approach is easier to perform than a caudal approach. b. An advantage of spinal over caudal anesthesia is that an indwelling catheter can be placed to redose the spinal block. c. A spinal is better than a caudal for a mid-thoracic block. d. Spinals generally require a higher volume of drug.

8. Which anesthesia option is not recommended for an ex-premature infant undergoing unilateral hernia repair? a. Local anesthetic infiltration supplemented with IV midazolam and fentanyl b. Spinal anesthesia, if IV sedatives are administered c. Caudal anesthesia, if IV sedatives are administered d. General anesthesia, if opioids are administered

9. Regional anesthesia is preferred over general anesthesia in ex-premature infants because: a. general anesthesia has been proven to cause neurotoxicity in infants b. apnea is less likely following regional anesthesia, if the patient undergoes little or no sedation c. monitoring of infants is not required when regional anesthesia is used d. infants can be sent home the same day when regional anesthesia is used

10. Which of the following describes a way to make caudal blocks safer in the ex-premature infant? a. Avoid using beveled hypodermic needles. b. Inject local anesthetics slowly and incrementally. c. Use epinephrine containing local anesthetic, and carefully monitor the electrocardiogram. d. All of the above are correct.

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This paperback is ideally suited for anesthesiologists, residents and nurse anesthetists who need a concise, practical, easily accessible reference on anesthesia equipment. It covers the most commonly used machines and devices and addresses common problems and pitfalls that affect clinical situations. The book is written in outline format and thoroughly illustrated with full-color photographs and line drawings.

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Atlas of Regional Anesthesia: Expert Consult Online and Print: Fourth Edition

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The meticulously updated new edition of this go-to reference brings state-of-the-art coverage and streaming online videos of ultrasoundguided techniques, as well as new coverage of the latest procedures.

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This book answers this question by incorporating engaging case studies that makes learning the competencies fun! Written by leading anesthesiologists from leading medical centers across the United States, this book brings the core clinical competencies to life for residents, attendings and medical students alike.

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Single Best Answer MCQs in Anaesthesia Cyprian Mendonca; Mahesh Chaudhari; Biju Kurian; Josephine James

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Smith’s Anesthesia for Infants and Children: Expert Consult Premium Edition—Enhanced Online Features and Print: Eighth Edition Peter J. Davis; Franklyn P. Cladis; Etsuro K. Motoyama This book delivers all the state-of-the-art guidance needed to provide optimal perioperative care for any type of pediatric surgery. It features online access to an image and video library, including ultrasound-guided pediatric regional blocks, review-style questions, plus the complete fully searchable text at expertconsult.com.

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NAPA is seeking a Pediatric Anesthesiologist at Cohen Children’s Medical Center, part of the NSLIJ Health System.

North American Partners in Anesthesia not only offers great benefits, but also a rewarding career path. Some advantages of a position with NAPA are: • Physician-owned and led • Advancement opportunities • Innovative and highly competitive compensation package

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Benefits of the NSLIJ Health System:

• Integral Faculty of the new NSLIJ Hofstra University School of Medicine • Cohen Children’s Medical Center provides a full range of pediatric services including a pediatric Level I Trauma Center program, and busy, high risk OB and neonatal services.

• Flexibility to participate in adult anesthesia services Please submit your CV to: Jeanne Wagner, Director of Clinical Recruitment jwagner@NAPAanesthesia.com Ph: 516-945-3096 • Fax: 516-626-6446

NAPA Pediatric Anesthesiologists at LIJ Medical Ad • Job# 10017 • 4C, 10.5" W x 6.5" H • EGC Group 516.935.4944

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AnesthesiologyNews.com I 49

Position Available:

Director of Pediatric Anesthesia The North Shore-LIJ Health System is currently seeking a Director of Pediatric Anesthesiology for The Cohen Children’s Medical Center. The Medical Center is undergoing significant expansion with 50 new patient care beds and eight new pediatric ORs. The Director of Pediatric Anesthesiology will lead a division responsible for a busy clinical service, research, resident education and medical student education as part of the new NSLIJ-Hofstra University School of Medicine. The candidate should be fellowship trained or equivalent, BC in Anesthesia with a minimum of 5-10 years experience in clinical research, education or pediatric anesthesia.

Please submit your interest to:

Dr. John DiCapua Chairman, Department of Anesthesiology Jdicapua@NSHS.edu or fax 516-945-3141

North American Partners in Anesthesia • Job# 10018 • 4C, 10.5" W x 6.5" H • EGC Group 516.935.4944

TE CH N OL OG Y

WHO continued from page 1 “It is of paramount importance that countries with limited resources have access to lifesaving technologies, such as pulse oximetry, and to sufficient education in order to use it to its highest standards in a sustainable way,” said Gerald Dziekan, MD, head of WHO’s Pulse Oximetry Project and Safe Surgery Saves Lives initiatives in Geneva. A third hospital in another low-income country will be added soon, Dr. Dziekan said. He declined to identify the country because of ongoing negotiations.

From Novel to Mandatory Pulse oximetry has become a standard of care in patient monitoring. It can be so useful for safe anesthesia that professional anesthesia societies in many countries consider its use mandatory. Worldwide, however, about 77,700 operating rooms (more than 19% of the total) lack pulse oximeters. Not unexpectedly, the shortage is particularly acute in poor and developing countries, where anesthesia providers lack both monitors and the knowledge of how to use them (Lancet 2010;376:1055-1061).

Two years ago, WHO initiated the Global Pulse Oximetry Project as part of its Safe Surgery Saves Lives initiative. The initiative features a 19-point presurgical checklist of evidence-based quality steps to enhance patient safety (see Anesthesiology News, April 2009, page 1). In a pilot project conducted at eight hospitals in major cities worldwide from 2007 to

‘There will never be a definitive prospective controlled trial, but pulse oximetry’s benefits are absolutely clear. Correctly applied, it will unquestionably lead to significant improvement in anesthetic outcomes in underresourced parts of the world.’

—John H. Eichhorn, MD 2008, use of the checklist reduced patient mortality from 1.5% to 0.8% (P=0.003) and reduced inpatient complications from 11% to 7% (P<0.001) (N Engl J Med 2009;360;491-499).

The fourth question on WHO’s Surgical Safety Checklist asks if the pulse oximeter is on the patient and functioning. Recognizing the shortage of oximeters, the World Federation of Societies of Anaesthesiologists (WFSA) is working with WHO to find ways of supplying affordable pulse oximeters and training to anesthesia practitioners in low- and middleincome countries.

“This project aims to provide not just equipment but also education and the establishment of standards

to produce a sustained change in practice,” said Alan Merry, MB, professor and head of anesthesiology at the University of Auckland, in New Zealand, team leader of the WFSA’s Global Oximetry Project and lead author of a discussion of its rationale (Anaesthesia 2009;64;1045-1050).

John H. Eichhorn, MD, senior author of the updated version of the WFSA International Standards for a Safe Practice of Anesthesia 2010 (Can J Anesth 2010;57:1021-1026; 1027-1034) strongly urged the initial adoption of pulse oximetry more than 20 years ago. He noted that the Global Oximetry goal is as much behavioral as technical.

“Pulse oximetry is unique in providing simple and efficient, truly continuous intraoperative monitoring that extends the human senses and thus provides early warning of adverse developments,” said Dr. Eichhorn, professor of anesthesiology at the University of Kentucky College of Medicine, in Lexington. “There will never be a definitive prospective controlled trial, but pulse oximetry’s benefits are absolutely clear. Correctly applied, it will unquestionably lead to significant improvement in anesthetic outcomes in under-resourced parts of the world.”

As part of this effort, physicians at Boston University Medical Center recently produced an instructional video on pulse oximetry. The high-definition video, translated into WHO’s six official languages (English, Spanish, Arabic, Russian, Mandarin and French), combines real and simulated operating room see WHO page 50

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T E C H NO L O G Y WHO continued from page 49 footage with computer-generated animation to explain the theory and use of oximetry equipment and what practitioners should do in case of hypoxemia.

In October, the video received an award for best scientific exhibit in patient safety from the Anesthesia Patient Safety Foundation during the 2010 American Society of Anesthesiologists annual meeting in San Diego (scientific and educational exhibit S-24).

“The most significant aspect of this effort is its global reach,” said Rafael Ortega, MD, professor and vice chair of academic affairs in the Department of Anesthesiology at Boston University Medical Center, which filmed and produced the video pro bono. “The ultimate goal is to make anesthesia as safe as it can be anywhere on the planet,” Dr. Ortega said.

Developing Countries Lag The impressive gains in anesthesia safety hinge on advances in technology, training and safer drugs. In developed countries, surgical mortality rates range from 0.4% to 0.8%, but they may be up to 10 times higher in developing countries. Mortality attributed to anesthesia in some parts of subSaharan Africa may be 200 to 1,000

times higher than that in industrialized countries (Anaesthesia 2009;64:1051-1060).

“Our hope is that through the Global Pulse Oximetry Project and its educational materials, anesthesia-related mortality and morbidity will continue to decrease everywhere, but particularly in developing nations,” Dr. Ortega said.

WHO is impressed with Dr. Ortega’s work. “It is an excellent example of transforming complex content into an engaging, visually appealing package of highest didactical standards,” Dr. Dziekan told Anesthesiology News. “We think that the educational video, together with other training materials, will help equip anesthesia providers around the world with crucial knowledge to provide anesthesia safely in challenging environments.”

Those interested in obtaining the video must wait until WHO determines the best distribution channels, expected sometime soon.

Although the video is aimed at individuals who might administer anesthesia without formal training in developing countries, any anesthesia and surgical team would benefit from it, Dr. Ortega said.

—Ted Agres

Compliance continued from page 33

A compliance program also is a pivot point around which to design additheir actions and activities are focused. tional business relationships. In this Yes, one purpose of a mandatory light, compliance prohibitions are compliance program under Obama­ highly useful “negative guides” for what care will be to assure qualifications for can be done. participation in government health Conclusion care programs. Another will be to reduce the chances for errors that lead One of the core principles of busito auditing or prosecution. And, the ness most often ignored in practice existence of an operating compliance (and almost always ignored by pracprogram that conforms to federal sen- tices) is the advantage of leverage, a tencing guidelines will help to reduce business multiplier. You are going to the consequences of criminal convic- be forced to have a compliance protion. Each of these purposes is a “pure” gram. You are going to be forced to compliance program goal and you, expend the funds and devote the time too, will incorporate them in design- and effort necessary to establish and ing and implementing your compliance operate it. Obtain leverage by using program. that same program and the funds, time When viewed strategically, your com- and effort in a strategic, proactive and pliance program becomes a tool for you profitable way, instead of simply treatto do more than simply assure “compli- ing them (begrudgingly) as efforts and ance for compliance’s sake.” It is a pivot expenses to be tolerated. point around which you can improve —Mark F. Weiss, JD your group’s financial performance.

For example, the framework of your Mark F. Weiss, JD, is an attorney who specialprogram can be used proactively to izes in the business and legal issues affecting examine and optimize the billing and anesthesia and other physician groups on a coding process, minimize billing mis- national basis. He holds an appointment as clinical assistant professor of anesthesiology at takes, drive faster completion of billing University of Southern California’s Keck School materials and speed of the billing cycle, of Medicine and practices with the Advisory Law examine the efficiency of outsourced Group, a firm with offices in Los Angeles and or in-house billing and collection oper- Santa Barbara, Calif., representing clients across ations, and examine options for post– the country. He can be reached by e-mail at ­markweiss@advisorylawgroup.com. billing service collections.

ClipChart Seattle: Avvo, a lawyer-grading service, is wading into the physician ranking business.

The startup announced recently that it is launching a registry of more than 800,000 U.S. doctors—roughly 90% of all licensed physicians in the country, according to the Seattle Times.

San Francisco: A state judge ruled that certified registered nurse anesthetists in California do not require the supervision of a physician to adminster anesthetics. The decision, which likely will be appealed, rejected the arguments of the California Society of Anesthesiologists and other medical groups that unsupervised CRNA practice violated state law.

Baltimore: Andy Harris, MD, an obstetric anesthesiologist at Johns Hopkins University, rode the Republican wave to capture a House seat in the 2010 midterm elections.

Dr. Harris’s main campaign pledge: to repeal the recently passed health care law. But his career on Capitol Hill got off to a rocky start. According to news reports, during a private orientation session for new lawmakers Dr. ­Harris complained that he would have to wait a month for his health care coverage to kick in.

Supporters of the law jumped on his impatience, arguing that uninsured Americans don’t have the luxury of any coverage, let alone high-quality, taxpayer-funded care.

INTRODUCING A BREAKTHROUGH IN ULTRASOUND NEEDLE VISUALIZATION. SonoSite’s Advanced Needle Visualization Conquers the Disappearing Needle Phenomenon.

The value of ultrasound guidance during nerve block is well established. But seeing the needle clearly when approaching a deep structure from a steep angle can be very challenging. (See “Study Ranks Needle Visibility Under Ultrasound,” Pain Medicine News, March 2010.)

Now a proprietary and patented software algorithm from SonoSite clearly enhances needle visualization while maintaining striking image quality of the target and surrounding anatomy – especially at the steep angels needed on deep procedures. And it’s available as a simple, software upgrade.

Advantages of SonoSite’s Advanced Needle Visualization: • • • •

No setup time No need for expensive additional hardware or special needles Simple on/off functionality Perfect for point-of-care procedures

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Physicians involved in early evaluations call this a significant step forward in visualizing the needle.

To see what they have to say, go to www.sonosite.com/needle

World leader and specialist in hand-carried ultrasound.

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www.sonosite.com/needle

©2010 SonoSite, Inc. All rights reserved. Specifications are subject to change. MKT02106 Rev B 10/10

Saphenous nerve block

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Smart clinical decisions require reliable information. That’s why GE Healthcare developed its Aisys® Carestation® – Digital Advantage Solution with digital technology that integrates critical patient data – in near real time and right at the point-of-care.

Digital Data

Even smarter yet is how the Aisys Carestation synchronizes this data with patient EMRs, streamlining recordkeeping and billing. Its easily upgradable digital platform is also a foundation for GE’s Navigator™ Applications Suite, which helps you predict the effects of drug interactions on your patients, and Centricity® Perioperative, which synchronizes surgery and anesthesia workflows, enabling you to optimize clinical and financial outcomes.

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Go to www.gehealthcare.com to learn more about Aisys Carestation – Digital Advantage Solution and other ways GE Healthcare is leading the digital revolution.

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