SmartTots Releases Consensus Statement Regarding Anesthesia Safety in Children
The Consensus Statement Is Endorsed by the International Anesthesia Research Society (IARS), US Food and Drug Administration (FDA), the American Academy of Pediatrics (AAP) and the Society for Pediatric Anesthesia (SPA)
(firmenpresse) - SAN FRANCISCO, CA -- (Marketwire) -- 12/14/12 -- 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:
"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."
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 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 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 , 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 , 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.
Contact
Tom Cooper
Executive Director
International Anesthesia Research Society
100 Pine Street, Suite 230
San Francisco, CA 94111
Web
Phone 415-296-6919
E-mail
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Datum: 14.12.2012 - 19:42 Uhr
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