Ramsay JG, Rappaport BA
Anesthesia & Analgesia

The safety of anesthetics administered to infants and young children is a growing public health concern. With a number of rodent and primate studies indicating neurotoxic outcomes as the result of clinically relevant exposures in very young animals to anesthetic drugs (many of which are also used as sedatives, especially in the intensive care setting), the medical and scientific communities are joining forces to determine whether the same risks apply to humans. The result of this multidisciplinary collaboration is a public-private partnership between the International Anesthesia Research Society (IARS) and the United States Food and Drug Administration (FDA), Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots (SmartTots).

In 2008, the FDA and the IARS began working together to create an administrative structure and scientific framework for SmartTots capable of identifying key research questions and overseeing investigations to ensure effective allocation of resources. In keeping with the recommendation by the FDA,1 we adopted a multidisciplinary approach involving broad and direct input from multiple stakeholders including professional societies and industry. Pharmaceutical companies, professional organizations, and more than 40 medical and scientific experts from around the world have since joined SmartTots.

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