With more than 1 million children younger than 5 years old in the United States receiving anesthesia for surgical procedures and thousands more for diagnostic procedures, the safety of anesthetics in young children is an important public health issue. Concerns about anesthesia affecting the developing brains of young children first emerged following findings of anesthetic agents inducing neuroapoptosis and subsequent behavioral deficits in pre-clinical animal model studies. The U.S. Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee specifically convened a meeting to discuss the potential clinical significance of the results of these studies in April 2007. This was followed by sponsorship of the Safe Kids initiative by the FDA, which provided initial support for clinical research to address this issue.

Since 2007, a large number of pre-clinical studies have provided robust evidence of...

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