FAQFrequently Asked Questions
What is SmartTots?
SmartTots is the IARS initiative 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. IARS works collaboratively with multiple stakeholders to leverage their collective resources in an effort to address this important issue.
What is the International Anesthesia Research Society (IARS)?
IARS is a nonpolitical, not-for-profit medical society dedicated to advancing and supporting scientific research and education related to anesthesia, and to improving patient care through research. Founded in 1922, the IARS contributes more than $1 million annually to fund anesthesia research and provides a forum for leaders in anesthesia research to share information and ideas. The Society publishes the Anesthesia & Analgesia Journal and sponsors the SmartTots initiative.
Why was SmartTots launched?
How is SmartTots organized?
In 2010 the IARS and the FDA established a collaborative relationship to leverage their collective resources and expertise to address the major scientific and clinical knowledge gaps regarding the safe use of anesthetics and sedatives in children. Many medical societies, patient support groups, pharmaceutical companies, and other organizations became involved. While the FDA partnership has concluded, IARS continues to coordinate SmartTots through a Steering Committee. A Scientific Advisory Board, including individuals from multiple institutions and specialty organizations, advises SmartTots regarding the complex, multi-year research needed to identify the safest approach to using anesthetic and sedative drugs in children.
What did the animal studies show?
How did the concerns about the safety of anesthetic drugs for infants and young children arise?
The FDA’s National Center for Toxicological Research (NCTR), as well as investigators at several universities, conducted research to study the effects of anesthetics on the nervous systems of developing animals. This research demonstrated that exposure to some anesthetics and sedatives caused memory and learning difficulties and other harmful changes in the central nervous systems of some laboratory animals. Currently, inadequate data exist to prove or disprove whether similar effects occur in children.
Is there any other research being done?
SmartTots continues to facilitate and support studies of existing anesthetic drugs and their effects on childhood development, as well as the impact of drug type, dosage amounts and number of exposures. Information from these research studies will:
- Help to determine if particular anesthetic drugs pose hazards to young children
- Help to design the safest anesthetic regimens (dose and duration)
- Potentially foster the development of new anesthetic drugs.
Current studies include:
- Jimcy Platholi, MS, PhD, Weill Medical College of Cornell University, Role of mossy fiber terminals in early anesthesia neurotoxicity
- Peter Szmuk, MD, UT Southwestern Medical Center, Neurodevelopmental outcome after standard dose sevoflurane versus low-dose
Should we be concerned about risks to humans?
The results from studies of anesthetic exposure in children have been mixed. Some studies have not found a link between the development of learning disabilities in children and the use of anesthetics. However, some study data have linked learning disabilities and behavioral problems with anesthetics administered in infants and children prior to three years of age. To learn more about the latest research findings see the SmartTots newsletter archive. Subscribe to the bi-monthly newsletter here: newsletter signup.
Is it harmful for infants and young children to undergo anesthesia?
Research in animals has raised concerns about anesthetic and sedative drugs. Risks to infants and children are not proven at this point; the research is ongoing and not yet conclusive.
What does this information really mean?
How do I access updated research related to this topic?
Check the SmartTots website regularly; we update the site on an ongoing basis to ensure the latest data is freely available.
How many young children undergo surgery each year in the United States?
What are the most common conditions requiring surgery for that age group?
Are there alternatives to general anesthesia for surgery in young children?
Which of those conditions can be dealt with using regional anesthesia?
Should we postpone surgical procedures that require anesthesia for infants and young children?
What about the safety of anesthetic agents used to sedate newborns in the Neonatal Intensive Care Unit?
How can I obtain more information?
Parents of children who have undergone surgery or require surgery should consult with their primary care physician, surgeon/proceduralist and anesthesia professional.