Over the last decade, studies in rodents and non-human primates have found that exposure to anesthetic agents during sensitive periods of brain development results in widespread neuronal apoptosis and functional deficits later in life. Recent population-based birth cohort studies have suggested there may also be adverse effects on brain development in humans.
Although the anesthesia community and the FDA agree there are insufficient data to demonstrate a causal link between the use of anesthetics and neurotoxicity in the human pediatric population, the need has grown to communicate accurately to practitioners and parents the current understanding of the risks.
On September 10, 2012, the International Anesthesia Research Society (IARS) in collaboration with the U.S. Food and Drug Administration (FDA) held a SmartTots Scientific Workshop at the FDA White Oak Campus in Silver Spring, Maryland. The goal of the workshop was to develop a consensus statement regarding the safety of anesthetic and sedative drugs administered to infants and young children. Attendees included over 60 experts in pediatric medicine and patient safety, including representation from several stakeholder organizations and SmartTots affiliates.
Workshop participants were charged with reviewing and discussing the available data; assessing the medical, ethical and legal implications of communicating this information broadly; and formulating a consensus statement that defines the problem and addresses the concern surrounding the risks and benefits associated with sedation and anesthesia in children.
SmartTots is currently finalizing the message with the assistance of our affiliates and will be releasing the consensus statement in late 2012.
For more information, contact Tom Cooper at [email protected].