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Health Day, June, 2004

June 9, 2004 By E.J. Mundell

WEDNESDAY, June 9 (HealthDayNews) — If you’ve ever had surgery requiring anesthesia, chances are that nausea and vomiting were part of your recovery process. In fact, surgical patients typically rate post-op stomach upset as more stressful than post-op pain.

However, a new study — the largest ever on the subject — finds that there are cheaper, more effective ways to lessen post-op queasiness.

The study might also help settle the controversy surrounding the use of the inexpensive anti-nausea drug droperidol, which has long been subject to an FDA safety warning that most anesthesiologists say is unwarranted.

The findings “provide for the first time really strong evidence for clinicians on how to select anti-nausea, anti-vomiting approaches for individual patients, based upon their risk,” explained lead researcher Dr. Christian Apfel, a professor of anesthesiology at the University of Louisville, Kentucky.

The study, involving more than 5,000 surgical patients selected from hospitals across Europe, is published in the June 10 issue of the New England Journal of Medicine.

Experts estimate that about one in every three patients undergoing surgery requiring anesthesia will experience nausea in the hours or days following the operation. Much of the blame for this nausea lies in the type of anesthesia or pain relievers used, with opioid drugs like morphine a major culprit. Abdominal and gynecologic surgeries appear to carry the highest risks for post-op vomiting, Apfel said.

But patient characteristics can play an important role, too, Apfel added.

“Female gender, nonsmoking status, a prior history of nausea or vomiting, and the use of opiates after surgery” all raise a patient’s risk of post-op nausea by about 20 percent each, Apfel said. Using these four factors, his team devised a nausea “Risk Score” that makes it easy for doctors to spot those patients in need of anti-nausea medications.

“If the risk is low — say, 10 percent — very few of those patients will benefit from prevention,” he explained. “But if the risk is high — say, 60 or 80 percent — then you need it.”

And what medications work best? Luckily for today’s budget-conscious hospitals, drug combinations involving cheaper, generic drugs like droperidol or dexamethasone worked just as well at preventing or quelling nausea as brand-name drugs costing 10 times as much, the researchers found.

This finding led Apfel’s team to recommend that, all things being equal, “the safest or least expensive [anti-nausea drugs] should be used first.”

The study may have an impact on the use of the generic anti-nausea medication droperidol, which many anesthesiologists believe has long been unfairly labeled as unsafe by the Food and Drug Administration.

Droperidol was first introduced 30 years ago as a drug used at very high doses to calm down psychiatric patients, but isolated reports of cardiac problems in those patients led the FDA to slap a “black box” warning on the drug’s packaging.

The warning is “ludicrous,” says Dr. Paul White, chair of anesthesiology at the University of Texas Southwestern Medical Center, who also wrote a commentary on Apfel’s study in the same issue of the journal.

When it comes to the much lower dose used by anesthesiologists, “there’s not been one case report about a cardiac problem associated with droperidol” in over 30 years, White said.

Apfel agreed. “The doses are tiny. All experts are in agreement here that this black box warning is not really justified,” he said. “It’s over the top.”

But as long as the black box warning remains in place, hospitals and physicians will continue to avoid the drug because of legal concerns, and also because the label mandates that patients get expensive EKG tests beforehand.

In the meantime, cash-strapped hospitals are using highly expensive, non-generic alternatives.

“It’s a very important issue when you consider how health-care dollars are expended,” White said.

But the very scale of Apfel’s study could change things. Already, droperidol is slowly gaining its place back on hospital pharmacy shelves, White noted.

“Hopefully, the study will also have an impact on regulators in Washington, D.C., who have made it difficult to use droperidol, which we now know is such a very cost-effective drug,” he added.

-By E.J. Mundell