SmartTots to research safer use of anesthesia in children

SmartTots, a partnership between the International Anesthesia Research Society (IARS) and FDA, is gathering more research on safe anesthesia for children under 4 years old.

Strategies for Mitigating Anesthesia Related Neuro-Toxicity in Tots (SmartTots), formerly known as SAFEKIDS, was given a new name that more accurately reflects the programs’ goal, which is to make anesthesia safer for children via multi-year research initiatives.

SmartTots plans to finalize and implement its research and fundraising agenda following the FDA’s Anesthetic and Life Support Drugs Advisory Committee meeting, held March 10. The Committee discussed findings from recent studies, including the relevance and impact of these findings on humans. “Definitively determining whether anesthetics pose harmful effects on the developing brain will likely take years of animal and human studies, as well as the expertise and resources of numerous individuals and organizations,” according to a statement from SmartTots.

Research on safe anesthetic drugs is essential because more than 1 million children a year under the age of 5 undergo surgical procedures requiring anesthesia, according to SmartTots. Non-clinical studies in juvenile animal models show that exposure to some anesthetics and sedatives is associated with memory and learning deficits and other neurogenerative changes in the central nervous system, according to SmartTots.

“SmartTots will allow us to learn how to give anesthesia and perform surgery safely on children under the age of 4,” said Michael Roizen, MD, leader of SmartTots’ executive board.

In 2008, FDA awarded 5 research contracts under the SmartTots’ initiative, including: Children’s Hospital of Boston for a study on long-term neurodevelopmental outcomes in pediatric patients administered regional or general anesthesia as neonates or infants; Arkansas Children’s Hospital Research Institute for study on the pharmacokinetics, pharmacodynamics, and neurotoxic effects of an anesthetic in infants undergoing various surgical procedures; Columbia University for a study on the effects of anesthetic exposure on neurocognitive, emotional and behavioral outcomes; and the IARS for managing SmartTots.