Frequently 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?
SmartTots was launched to further 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, to design the safest anesthetic regimens (dose and duration), and potentially foster the development of new anesthetic drugs.
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?
In humans, the formation of brain structures and rapid brain growth starts early in pregnancy and continues for up to three years.12 In rats and mice, the comparable period of brain development is the first two weeks of life.3 In the animal research studies, when administered during rapid brain growth in rodents, all of the anesthetics and sedatives commonly used in infants and children caused widespread loss of nerve cells and/or later abnormal behavior. 4,5,6,7,8,9,10 Recent data show that a loss of nerve cells in the brain also occurs when commonly used anesthetics are administered to newborn monkeys. 11,12
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?
Although research in animals is often very helpful, it may sometimes cause undue concern and prompt changes in medical practice that have unintended consequences that are not in the best interest of children. Much more research is needed to provide parents with additional information about the safe use of anesthetic and/or sedative drugs in children. Until more information is available it is important that children continue to receive any necessary surgery and anesthesia.
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?
In the United States alone, more than 1 million children 4 years of age or younger undergo surgical procedures requiring anesthesia each year.15
What are the most common conditions requiring surgery for that age group?
The most common procedures required for young children include ear tubes for chronic ear infection, tonsillectomy, hernia repair, and circumcision,15 all procedures that typically last less than 60 minutes.
Are there alternatives to general anesthesia for surgery in young children?
For most surgical procedures there are no realistic alternatives to the medications used for general anesthesia.16,17,18
Which of those conditions can be dealt with using regional anesthesia?
Some procedures, including circumcision and hernia repair, may be performed using local or regional anesthesia such as the injection of a numbing medication similar to that used for epidural anesthesia to relieve discomfort associated with childbirth. However, the vast majority of children that require a surgical procedure must have general anesthesia using the medications that have raised concerns in animals.
Should we postpone surgical procedures that require anesthesia for infants and young children?
Children do not undergo surgical procedures that require anesthesia unless the surgery is essential to their health. Therefore, postponing a necessary procedure may itself cause problems and would not be an option for the majority of children. For example, children with chronic ear infections may have delays in the development of speech related to problems with hearing. Surgery to treat this problem may improve learning whereas a delay may result in long-term difficulties in the normal development of speech. Parents of children requiring surgery should consult an anesthesiologist or other qualified physician for advice about their child’s situation.
What about the safety of anesthetic agents used to sedate newborns in the Neonatal Intensive Care Unit?
Some of the intravenous drugs used to sedate newborns in the Neonatal Intensive Care Unit have been shown to injure brain cells in neonatal animal models. It is unknown whether these drugs cause any brain damage in human infants or whether they produce any long-term effects on behavior or learning. This is an important area for investigation.
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.