Pediatric Anesthesia

Millions of children receive anesthesia and sedation drugs each year for surgeries and procedures; however, until recently, little was known about these drugs’ effects on the developing brain. Research studies have found that early exposure in juvenile animals to anesthetics and sedation drugs is associated with neurodegenerative changes in the developing brain. The FDA acknowledges that there are insufficient human data to determine the clinical relevance of these animal findings to pediatric patients. Therefore, additional non-clinical and clinical studies are needed to assess the effect of anesthetics and sedation drugs on the developing human brain, including long-term studies in neonates and young children. To further this research effort, FDA has collaborated with the International Anesthesia Research Society (IARS) to form a Public Private Partnership, SmartTots, under the Pediatric Anesthesia Safety Initiative (www.smarttots.orgdisclaimer icon).

Latest Information

Previous Advisory Committee Meetings



2014 FDA Science Board


Consumer information pieces


Lin EP, Soriano SG, Loepke AW (2014) Anesthetic neurotoxicity. Anesthesiol Clin 32:133-155.

Mellon RD, Simone AF, Rappaport BA (2007) Use of anesthetic agents in neonates and young children. Anesth Analg 104:509-520.

Rappaport B, Mellon RD, Simone A, Woodcock J (2011) Defining Safe Use of Anesthesia in Children. N Engl J Med 364:1387-1390.

Vutskits L (2012) Anesthetic-related neurotoxicity and the developing brain: shall we change practice? Paediatr Drugs 14:13-21.

Zhou Z, Ma D (2014) Anaesthetics-induced neurotoxicity in developing brain: an update on preclinical evidence. Brain Sci 4:136-149.

Page Last Updated: 04/27/2017
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