SOURCE: SmartTots


July 18, 2011 14:12 ET

SmartTots to Determine Safety of Anesthetic Drugs in Young Children

Research Priorities Focused on Bridging Gap Between Animal Data and Humans

SAN FRANCISCO, CA--(Marketwire - Jul 18, 2011) - SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) unveiled its research agenda today, acknowledging insufficient human data available to determine whether anesthetics induce neurodegenerative changes in the central nervous systems of infants and young children. The agenda was developed in response to the U.S. Food and Drug Administration's Anesthetic and Life Support Drugs Advisory Committee Meeting in March, which solidified the need for additional clinical and non-clinical research studies to definitively assess the effects of anesthetics and sedatives on the developing brain.

SmartTots will dedicate its preliminary investigations to determining whether a signal, suggesting anesthetics induce neurodegeneration in the developing human brain, exists. Research will be based on worst-case scenarios, focusing on volatile anesthetics administered during developmental periods of rapid brain growth in high-risk circumstances, such as prolonged sedation.

"It is not currently clear whether the results from the animal studies are applicable to pediatric medicine," said SmartTots Scientific Advisory Board Co-Chair Alex Evers, MD. "Determining whether anesthetic exposure can inflict harm on the developing human brain is a vital determination and our first priority."

Investigations will likely use in vitro and rodent models as strategic screening mechanisms before investigations are moved to higher, non-human primates. Researchers will be working to determine which anesthetics, if any, cause developmental neurotoxicity and at which dose, duration and frequency of exposure. SmartTots will define the most susceptible periods of developmental vulnerability, and verify whether any short or long-term neurocognitive, emotional, behavioral, or social outcomes result from exposure to anesthetic agents.

"SmartTots is committed to ensuring the safety of the millions of infants and young children undergoing anesthesia each year," said SmartTots Executive Board Chair Dr. Mike Roizen. "The proven safety of anesthetics administered to children is an important public health concern."

Should results show anesthetics do induce developmental neurotoxicity, SmartTots will identify and implement approaches for preventing and mitigating neurotoxic outcomes. SmartTots anticipates these complex studies will require years of research, large sums of funding, and numerous scientific and medical collaborations.

"The road ahead is challenging, but the mission is essential for society and for your kids," said Dr. Roizen. "We need to generate the evidence necessary to ensure the safety of anesthesia for your children."

About SmartTots
SmartTots is a Public-Private Partnership between the U.S. Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS) designed to close research gaps related to the effects of anesthetics on the developing brain, and ensure the safety of infants and young children undergoing anesthetics in surgical procedures. Findings from SmartTots research studies will determine the safety of commonly used anesthetics, establish new practice guidelines, and potentially foster the development of new, safer anesthetics and sedatives. For more information, visit

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