Abstract
Approximately 1.5 million neonates receive general anesthesia each year for a surgical procedure. Despite this being an essential practice, a number of recent studies now indicate that anesthetic exposure could cause toxicity and neuronal apoptosis in the developing brain. This could potentially influence long-term neurodevelopmental outcome, especially premature infants in need of multiple surgical procedures. Most anesthetic drugs routinely administered to neonates have not been adequately tested for safety or efficacy. Given the number of confounders, dosing is often extrapolated from adults. This is concerning since many different drugs can be administered concurrently, with few of these agents actually approved for use by the Food and Drug Administration. Since 1997, legislation has been passed in the United States and abroad encouraging more drug investigation in infants and children. This has resulted in over 500 labeling changes to products regarding safety and efficacy in various pediatric age groups. However, only three drugs routinely used as anesthetic agents in newborn infants have had any updated labeling (none in very premature infants). This “off-label” use without adequate testing must be addressed. Therefore, more clinical trials of common anesthetic agents used alone and in combination in neonates are urgently needed.
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Acknowledgements
The authors acknowledge and thank Robert “Skip” Nelson, MD PhD (Deputy Director and Senior Pediatric Ethicist, Office of Pediatric Therapeutics, Food and Drug Administration) for his input and advice. Dr. Davis is Chair of the Neonatal Advisory Committee, Office of Pediatric Therapeutics, FDA.
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Nasr, V., Davis, J. Anesthetic use in newborn infants: the urgent need for rigorous evaluation. Pediatr Res 78, 2–6 (2015). https://doi.org/10.1038/pr.2015.58
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DOI: https://doi.org/10.1038/pr.2015.58
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