By Patrick E. Clarke, Office of Communications
One of the most difficult decisions parents face is whether their young child should have surgery. The issue becomes more complicated due to concerns about a child's response to general anesthesia or sedation. To provide parents and doctors with the information they need when faced with such a dilemma, the U.S. Food and Drug Administration and the International Anesthesia Research Society (IARS) have created Strategies for Mitigating Anesthesia-Related neuro-Toxicity in Tots or SmartTots.
SmartTots will coordinate and fund research intended to make surgery, anesthesia and sedation safer for infants and young children. This research will help determine if any particular anesthetic or sedative drugs pose hazards to young children, design the safest anesthetic and sedative regimes and potentially foster the development of new anesthetic and sedative drugs.
“We urgently need to come together to develop the research agenda, determine what kind of research needs to be done and obtain funding in order to generate this needed evidence,” said Dr. Janet Woodcock, director, FDA's Center for Drug Evaluation and Research.
More than one million children a year under the age of five undergo surgical procedures requiring anesthesia in the United States. The most common procedures include ear tubes for chronic infection, tonsillectomy, hernia repair and circumcision.
“Every time you get anesthesia during surgery, there’s a risk. But there may be a special risk for children under four,” said Dr. Michael Roizen, leader of the Executive Board of SmartTots. “SmartTots will allow us to learn how to give anesthesia and perform surgery safely on children under the age of four.” IARS is a research-based organization dedicated to advancing the scientific basis for anesthesia practice.
While there is no direct evidence that anesthesia or sedation are unsafe for children, recent studies have shown an urgent need for research into the potential risks of using anesthesia and sedation on the development of children under age four.
Animal studies done by FDA’s National Center for Toxicological Research (NCTR) and several university investigators have shown that anesthesia and sedative exposure can cause harmful neurological changes in young rats and mice. Commonly used anesthetics caused widespread loss of nerve cells and abnormal behavior. FDA studies in non-human primates found similar neurological problems.
Alternatives to the medications typically used in children who require general anesthesia are few and do not represent a realistic alternative.
“If you could postpone surgery for those under the age of four, that would be fine,” said Roizen. “But for most procedures, you can’t delay them because they are important for the child’s development and health.”
Request for Applications
SmartTots is accepting applications aimed at investigating whether anesthetics/sedatives are neurotoxic and/or impede the normal development of the human brain.
Resources For You
- CDER Conversations: SmartTots
- Consensus Statement on the Use of Anesthetics and Sedatives in Children
- Dr. Mike Roizen Takes SmartTots to India
- SmartTots to Determine Safety of Anesthetic Drugs in Young Children
- Video: SmartTots to Help Make Anesthetics and Sedatives Safer for Children
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