FDA WORKS TO UNDERSTAND THE SAFETY OF ANESTHESIA FOR INFANTS AND YOUNG CHILDREN

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
When infants or young children need surgery, does anesthesia affect their developing brains?

With more than 1 million children under age 4 requiring anesthesia for surgery in the United States each year, the Food and Drug Administration (FDA) and other health organizations are working together to answer this question.

Previous scientific studies in young animals have shown that commonly used anesthetics can be harmful to the developing brain. However, results have been mixed in children. Some studies of infants and young children undergoing anesthesia have reported long-term deficits in learning and behavior; other studies have not.

These conflicting results show that more research is needed to fully understand the risks anesthesia may pose to very young patients.

To close these research gaps, FDA and the International Anesthesia Research Society (IARS) started an initiative called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots). SmartTots seeks to ensure that children under age 4 will be as safe as possible when they need anesthesia during surgery. Studies have shown that this is a period of significant brain development in young children.

"Our hope is that research funded through SmartTots will help us design the safest anesthetic regimens possible," says Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products at FDA. "This research can potentially foster the development of new and safer anesthetic drugs for use in pediatric medicine."

According to SmartTots steering committee co-chair James Ramsay, M.D., young children usually do not undergo surgery unless the procedure is vital to their health. "Therefore, postponing a necessary procedure may itself lead to significant health problems and may not be an option for the majority of children," Ramsey says.