FRIDAY, Oct. 7 (HealthDay News) -- Exposing children to MRIs during pediatric clinical trials is not unduly risky to their well-being as long as sedation and injectable dyes aren't used, new Canadian research concludes.
The study finds that MRIs, when used without additional intravenous contrast dyes or sedation, pose no greater physical or psychological harm to healthy children than routine activities such as playing sports or riding in a car.
However, injectable contrast dyes, which are used to improve scan resolution, may pose an unreasonable allergic-reaction risk that is greater than that posed by, for example, routine vaccinations, the researchers found.
Similarly, using sedation during imaging sessions appears to raise the risk for side effects, such as gastrointestinal issues and motor imbalance, to a level considered unsafe for children.
Lead author Dr. Matthias H. Schmidt, an associate professor in the department of radiology at Dalhousie University in Halifax, Nova Scotia, reported his team's findings in the September/October issue of IRB: Ethics & Human Research.
Schmidt and his colleagues noted that research ethics review boards have long struggled with the question of MRI safety in the context of pediatric research.
The team thus set out to establish so-called "minimal-risk standards" for pediatric imaging exposure safety by analyzing a range of information, including MRI safety data collected by the U.S. Food and Drug Administration's "Manufacturer and User Facility Device Experience."
The bottom-line: Ice hockey and soccer pose as much, if not more, risk for physical injury to children as MRIs.
While the risk for physical injury to children posed by an hour-long MRI is 17 for every 100,000 imagings, the risk for injury is as high as 12,730 for every 100,000 hours a child under the age of 16 plays ice hockey, the study fou
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