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Smarttots initiative plans research to answer questions onanesthetic safety in children by vacuumse mse





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Smarttots initiative plans research to answer questions onanesthetic safety in children by
Article Posted: 08/09/2013
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Smarttots initiative plans research to answer questions onanesthetic safety in children


 
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A special section of the November issue of Anesthesia & Analgesia,official journal of the International Anesthesia Research Society(IARS), presents new research, updates, and commentaries aboutpossible toxic effects of anesthetics and sedatives in infants andyoung children. The IARS is a key partner in the SmartTotsinitiative, dedicated to finding scientific answers to these urgentpublic health concerns. SmartTots is a public-private partnership between the IARS and theU.S. Food and Drug Administration, with involvement otherscientific organizations, pharmaceutical companies, and medical andscientific experts from around the world. "We are optimisticthrough SmartTots we will be able to determine the neurologicrisks, if any, of exposure to sedative and anesthetic agents to ourinfants and children," according to an introductory article by DrsJames G.

Ramsay and Bob A. Rappaport, Co-Chairs of the SmartTotsSteering Committee. SmartTots Sets Agenda for Research on Anesthetic Safety in Children SmartTots was organized in response to studies showing evidence ofneurotoxicity (toxic effects on the brain and nervous system)caused by exposure to anesthetic drugs in developing animals. Sincemany of the same drugs are also used as sedatives especially incritically ill children it's critical to determine whether similarneurotoxic effects occur in humans.

"With more than 6 million infants and children exposed to sedationand anesthesia in the United States on an annual basis, theimplications of any recommendation regarding these agents areimmense," write Drs Ramsay and Rappaport. However, firm scientific evidence is needed to guide anyrecommendation for changing clinical practice in children. The goalof SmartTots is to raise the funds needed to support the criticalresearch studies that will provide the data on which to base theserecommendations. So far, the SmartTots Scientific Advisory Board has set ascientific research agenda and issued a request for researchapplications.

The IARS has contributed $200,000 to fund the initialstudies. Closing the gaps in research is expected to take severalyears, at a cost of up to $40 million. Major fund-raising andpublic awareness efforts are underway, with an Executive Board ledby well-known physician and author Dr Michael Roizen. Experts Agree More Research Needed before Making Changes inAnesthesia Practice Meanwhile, research is moving forward in several key areas.

TheNovember Anesthesia & Analgesia discusses several reports presentedat a special session on neurotoxicity of anesthesia in childrenheld at this year's IARS Annual Meeting. These include an important new study reporting a possible increasein developmental and behavioral disorders among children exposed toanesthetics before age three. The study, based on New York State Medicaid data was led by Charles DiMaggio, PhD, of Columbia University.With adjustment for other factors, children with early anestheticexposure were 60 percent more likely to be diagnosed withdevelopmental or behavioral disorders, compared to a group ofsiblings who did not undergo surgery. (The use of a siblingcomparison group helps to avoid genetic and other differences thatmight contribute to risk.) However, there was no apparent increase among children who had onlyone operation although risk increased progressively for those withtwo or more operations. In addition, a more tightly matchedanalysis of 138 sibling pairs (one with and the other withoutexposure to surgery/anesthesia) found no increase in risk.

In an accompanying editorial, Dr Joss Thomas of University of IowaCarver College of Medicine and colleagues write, "[W]e believe thatevidence is most consistent with the premise that anesthesia perse, given to a healthy child who needs only a 'routine' surgicalprocedure, is not neurotoxic." They emphasize the need for"conclusive evidence" before making any changes in practice. The November A&A also includes a pair of experimental studiesexamining one possible mechanism by which anesthetics might causeneurotoxic effects in the brains of young animals specifically,through calcium overload in brain cells. In another article, DrGreg Stratmann of University of California San Francisco reviewsthe evidence on neurotoxicity associated with anesthetic exposurein the developing brain. He echoes the call for definitive evidencebefore making any change in clinical practice: "Until we know ifand how pediatric anesthesia affects cognition in humans, a changein anesthetic practice would be premature, not guided by evidenceof better alternatives, and therefore potentially dangerous." Additional References Citations.

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