SPS Endorses the SmartTots Consensus Statement on the Use of Anesthetic Drugs in Infants and Toddlers
By Patricia Scherrer, MD
The Society for Pediatric Sedation is proud to be one of the endorsing organizations for the recently published Consensus Statement from the SmartTots collaborative.
SmartTots, the acronym for Strategies for Mitigating Anesthesia-Related Neurotoxicity in Tots, is a partnership between the US Food and Drug Administration and the International Anesthesia Research Society. The mission of this collaborative is “to coordinate and fund research with the goal of ensuring safe surgery for the millions of infants and young children who undergo anesthesia and/or sedation each year.”
The group first released a statement regarding the potential risk of anesthetic exposure to the developing brain back in 2012. In June 2014, members of the collaborative met to review new evidence regarding sedative and anesthetic associated neurotoxicity and to update the original consensus statement. The resulting updated draft consensus statement was sent to a number of relevant organizations, including the SPS, for review and comment.
After several rounds of edits, the final statement was sent back to these organizations for final affirmation. All of the involved societies and associations did choose to endorse the 2015 Consensus Statement, which can be found at www.smarttots.org/about/consensus-statement/.
The statement recommends that healthcare providers discuss with parents and families that current data regarding risk is unclear. In most currently available research on neurotoxicity in animals, all currently available sedative and anesthetic agents commonly utilized for infants and children cause loss of nerve cells and/or behavioral differences when administered to infant animals during their period of rapid brain growth. Observational results in children have been varied.
Because all agents have been associated with neurologic changes in animals, no specific medication or regimen can currently be chosen as safer than another. Decisions regarding timing of procedures requiring sedation or anesthesia should be discussed with all members of the child’s care team, including parents/caregivers.
The SmartTots group is facilitating and providing support to a number of ongoing research studies designed to evaluate sedative and anesthetic medications, regimens, and exposures and their potential association with neurotoxicity in infants and young children. Background studies on neurodevelopmental outcome as correlated with sedative/anesthetic exposure are underway. The SmartTots research team is also actively planning initial prospective randomized clinical trials evaluating comparative neurodevelopmental outcomes for one anesthetic regimen versus another.
Preliminary results from the GAS study, General Anesthesia Compared to Spinal Anesthesia, were released in October concerning neurodevelopmental outcome at two years of age. The primary endpoint of the study will be a comparison in cognitive development at five years of age between children who received a single sevoflurane anesthetic of approximately one hour in duration versus children who received awake-regional anesthesia for an inguinal herniorrhaphy. The risk of adverse neurodevelopmental outcome at two years of age, the secondary outcome of the study, was found not to be statistically significantly different between the two groups.
Although the outcome at five years may be more sensitive in detecting adverse changes, results of this initial report are cautiously encouraging regarding risk associated with single, limited duration procedures. However, this study does not address multiple sedative/anesthetic exposures over time.
The SPS will remain very involved in reviewing the available data regarding procedural sedation and monitored anesthesia care regimens and in collaborating on future consensus statements as more information becomes available. Please also see the SmartTots website at www.smarttots.org for additional resources for parents and health care providers, as well as the latest information regarding their research efforts.