SmartTots released a consensus statement today regarding the safety of anesthetics and sedative agents administered to infants and young children. This statement is the end product of a scientific workshop on September 10, 2012 at the FDA White Oak Campus in Silver Spring, Maryland, which convened experts in anesthesia and pediatric medicine, as well as individuals involved in patient safety and advocacy.
"This consensus statement is a key step toward identifying the safest anesthesia and sedative medications for our nation's infants and children," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "The FDA is proud to be a SmartTots partner in this research effort and to have taken part in the recent workshop."
After a full day of data review and evaluation, the Workshop successfully resulted in a consensus statement endorsed by the IARS, FDA, AAP and SPA:
Each year, millions of young children require surgery and other procedures for serious or life-threatening medical conditions or to improve their quality of life. Anesthetic and sedative drugs are widely used to help ensure the safety, health, and comfort of children undergoing these procedures. However, increasing evidence from research studies suggests the benefits of these agents should be considered in the context of their potential to cause harmful effects.
Previous research in young animals and children has raised concerns that exposure to commonly used anesthetics may produce adverse neurobehavioral effects. However, these studies had limitations that prevent experts from drawing conclusions on whether the harmful effects were due to the anesthesia or to other factors, including surgery, hospitalization, or pre- existing conditions. Furthermore, the findings in children have been mixed, with some studies of infants and young children undergoing anesthesia or sedation finding long-term deficits in learning and behavior, while others have not.
Clearly, additional research is urgently needed to identify any possible risks to young children. In the absence of conclusive evidence, it would be unethical to withhold sedation and anesthesia when necessary. Instead, healthcare providers should do the following:
"As an organization dedicated to the health of children, the American Academy of Pediatrics naturally wanted to play a role in developing the consensus message on this important safety topic," said Dr. Thomas McInerny, AAP president. "Anytime a child undergoes a surgical procedure requiring anesthesia or sedation, parents will have questions about possible risks. Additional research is urgently needed to expand what we know about the health effects of anesthesia. Meanwhile, the Academy encourages parents to be educated about the risks and benefits of anesthesia and surgical procedures performed on their child."
"Recent studies have raised concerns about the safety of anesthetics for our pediatric patients, as they are at a critical developmental period," said Dr. Nancy Glass, SPA president. "However, definitive answers regarding the effects of anesthesia in children remain inconclusive. While the experts continue to investigate treatments and develop these important answers, it's important that the medical and scientific communities work together to communicate our knowledge in a unified message, with patient safety at its core."
The consensus message is intended to enable immediate awareness and education for parents and physicians while research studies look for more definitive data to either prove or disprove the existence of real and clinically relevant risks to children. SmartTots is actively securing funds for new and ongoing investigations that will help close research gaps and ensure the identification of safe anesthetic treatments.
"The IARS is fully committed to supporting the urgent fund raising and research agenda that are represented by SmartTots," said Dr. James Ramsay, co-chair of the SmartTots Steering Committee and past chair of the IARS Board of Trustees. "It's imperative we work together to scientifically determine the safest way to care for our youngest patients as they undergo necessary procedures requiring sedation or anesthesia."
SmartTots is a Public-Private Partnership between the U.S. Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS) designed to close research gaps related to the effects of anesthetics on the developing brain, and ensure the safety of infants and young children undergoing anesthetics in medical procedures. Findings from SmartTots research studies will determine the safety of commonly used anesthetics, establish new practice guidelines, and potentially foster the development of new, safer anesthetics and sedatives.
The International Anesthesia Research Society is a nonpolitical, not-for-profit medical society founded in 1922 to advance and support scientific research and education related to anesthesia, and to improve patient care through basic research. The IARS contributes nearly $1 million annually to fund anesthesia research, sponsors an annual forum for anesthesiology leaders to share information and ideas, maintains a worldwide membership of more than 15,000 health professionals in anesthesia-related practice, sponsors the SmartTots Initiative, and publishes the academic journal Anesthesia & Analgesia.
The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.
The U.S. Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The Society for Pediatric Anesthesia, comprised of nearly 3,000 pediatric anesthesiologists, is an organization dedicated to advancing the safety and quality of anesthetic care, perioperative management, and the alleviation of pain in children. The organization invests heavily in ongoing education of its members and other providers, in funding pediatric anesthesia research, and in strategic partnering with other healthcare organizations to benefit the care of children.
The Society for Neuroscience in Anesthesiology and Critical Care is an international, multidisciplinary Society comprised of 650 members and is dedicated to advancing the art and science of the care of neurologically impaired patients. It provides education in neuroanesthesia and neurocritical care, and is a forum for interdisciplinary discussion and collaboration between basic and clinical neuroscientists. The Society’s journal, the Journal of Neurosurgical Anesthesiology, is published quarterly.