FAQ

Frequently Asked Questions

SmartTots

What is SmartTots?
SmartTots is a Public-Private Partnership (PPP) between the US Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS). The mission of this partnership is to coordinate and fund a research program with the goal of ensuring safe surgery for the millions of infants and young children who undergo anesthesia and/or sedation each year.
What is the International Anesthesia Research Society (IARS)?
The IARS is anesthesiology’s non-political organization focused on providing scientific and evidence- based safe anesthesia care. 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 in partnership with the FDA.
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?
The IARS and the FDA signed a formal Memorandum of Understanding in 2010 establishing 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 are also involved. The FDA and IARS are coordinating the SmartTots Partnership through a Steering Committee. An Executive Board, led by Dr. Mike Roizen, is leading the fundraising effort, while a Scientific Advisory Board has been established to select the best studies to foster the complex, multi- year research needed to identify the safest approach to using anesthetic and sedative drugs in children. In addition, an Affiliate Advisory Council and an Industry Advisory Council provide broad and direct input from multiple specialty organizations and industry.

Research

What is the National Center for Toxicological Research (NCTR)?
NCTR is an internationally recognized research center at the FDA that supports the goal of improving patient and consumer safety. NCTR, along with other centers at the FDA, conducts research to support the scientific basis for the FDA’s regulatory decisions and reduce risks associated with products regulated by the FDA. One of the ways that NCTR helps assess possible risks to human health is to perform animal research studies that investigate the potential for adverse effects and mechanisms of injury following exposure to potentially dangerous chemicals.
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. More information on the results of early animal studies is below.
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, to design the safest anesthetic regimens (dose and duration), and potentially foster the development of new anesthetic drugs. SmartTots and the FDA are working closely to coordinate and fund future research programs with the goal of improving the safety of surgery.

Current studies include:

  • Lena Sun, MD, Columbia University Medical Center, Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) Study
  • Mary Ellen McCann, MD, MPH, Harvard Medical School, Boston Children’s Hospital, The GAS Study
  • Jeffrey Sall, PhD, MD, University of California San Francisco, Recognition Memory Following Early Childhood Anesthesia 
  • Caleb Ing, MD, Columbia University, Anesthetic Exposure Duration and Effects on Cognitive and Language Ability
  • Ansgar Brambrink, MD, PhD, Oregon Health & Science University, Long-Term Outcome of Single vs. Triple Anesthesia Exposure of Infant Monkeys

Additionally, SmartTots is working with an international team of expert neuroscientists to develop a clinical trial.  Several other studies, independent of FDA, IARS and the SmartTots Public-Private Partnership, are also underway at major universities. 

SmartTots is accelerating its efforts to fundraise to ensure that this important research continues.  Learn how you can help at SmartTots.org/donate.  Additional grant opportunities will be announced as funding becomes available.

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 with the use of multiple anesthetics administered in infants and children prior to four years of age. Researchers have found that two exposures to anesthetics before age four increased the likelihood of future learning disabilities in reading, writing, and math by 50% and three or more exposures created an even greater risk for learning problems. However, exposure for less than two hours did not appear to be linked to learning difficulties.13 In a recent study, children exposed to anesthesia for surgery and diagnostic testing before 3 years of age had a 1.7-1.8 times increased incidence for deficits in language and abstract reasoning at 10 years old. Differences were found even in children who only had a single exposure.14
Is it harmful for infants and young children to undergo anesthesia?
The early research in animals has raised concerns about some anesthetic drugs that need to be investigated further to determine if there is a risk to infants and children younger than four years of age. However, this research is very limited and is not yet conclusive. Dangers to infants and children from anesthesia are unproven at this point. There is no direct evidence that anesthetics are unsafe for children.
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.
Where and when will the results from these studies be published?

Check back on our website for information regarding research funded by SmartTots, we will ensure updates occur as soon as new information becomes available.  Press releases will be issued when research findings are published.

 

General

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.