The United States Food and Drug Administration (FDA) recently issued an update on general anesthesia for children less than 3 yr of age and pregnant patients in their third trimester.1 They cited a body of evidence in animal and human studies suggesting that the use of anesthetic or sedative drugs may affect neural development. Specifically, they advise caution in exposures lasting more than 3 h or with multiple procedures with cumulative exposure. With this announcement, the FDA has issued new labeling requirements for these drugs, including a warning to healthcare providers of the potential deleterious effects. This comes at a time when sedation is used widely in children.2,3
This warning is wide-reaching and not limited by drug class or utilization: inhalational agents (eg, halothane, desflurane) and intravenous sedatives (eg, propofol, ketamine, pentobarbital) are considered. As neurological surgeons caring for these patients, this warning could have a significant impact on our practice.
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