More Data, But Few Answers For Anesthesia Safety in Peds

By Karen Blum
Silver Spring, Md.—Four years after the FDA convened a panel of experts to discuss a possible relationship between general anesthesia and cognitive damage, experts say there still is not enough scientific evidence to define anesthetic drugs’ effects on children’s development or recommend any changes in anesthesiology practice.

A panel of about 30 academic and government physicians and scientists met at the FDA March 10, to review a variety of clinical and animal studies published on this topic since their initial meeting in 2007. The panelists agreed that although several studies have indicated that exposure to anesthetic agents during periods of significant brain development in young children can result in neuronal cell death or later cognitive deficits, it’s difficult to generalize the results. Animal studies may have exposed subjects to longer periods of anesthesia than children would experience, and the few human studies so far have conflicting results.

“Although we have made some progress since the last committee meeting, the progress hasn’t been huge,” said panel chair Jeffrey Kirsch, MD, professor and chair of anesthesiology and perioperative medicine at Oregon Health & Science University, in Portland.

The panel recommended that the FDA conduct a survey to determine areas in need of research, establish standard practice in the United States and globally find the “low-hanging fruit,” and focus research on areas that will have the biggest impact on numbers of patients. Studies should carefully note drug dosages, ages of children studied, their duration of exposure to anesthetic agents and measure children’s function prior to anesthesia exposure, to best define the short- and long-term effects of surgical and anesthetic interventions.

Panelist Susan Swedo, MD, chief of pediatrics and neurodevelopmental science at the National Institute of Mental Health, in Bethesda, Md., said she read minutes from the 2007 committee “and at least on the preclinical side, I would say that 90% of what they had identified would still be true today. We need more data in the area of currently used agents in real-dose situations, and I would like to have the brain-behavior literature much more richly described.”
Menu 0 $0.00