The FDA is initiating a study to determine the effects of anesthesia on the neurocognitive development of infants and children because of "major gaps" in scientific data about the safe use of anesthetics and sedatives on pediatric patients, says the agency.
Previous studies conducted on juvenile animals by the FDA’s National Center for Toxicological Research linked memory loss, learning deficits and neurodegenerative changes in the central nervous system to anesthetic and sedative exposure. The FDA says its new research, called Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS), aims to determine if children are affected in the same way. Initial results of the research will be available in two years.
Frank M. Torti, MD, MPH, acting commissioner of the FDA, says "the long-term benefits of these studies will inform risk-benefit decisions that both anesthesiologists and parents must make when considering the choice of anesthesia in pediatric patients."
Working with the FDA on the SAFEKIDS initiative are the International Anesthesia Research Society, Children’s Hospital of Harvard University, Little Rock’s Arkansas Children’s Hospital Research Institute, New York’s Columbia University and the Mayo Clinic of Rochester, Minn.
—Daniel Cook
