Physical and psychological risks meet minimal-risk standards, but contrast, sedation up risks
THURSDAY, Oct. 13 (HealthDay News) -- Use of magnetic resonance imaging (MRI) in pediatric clinical trials meets the minimum-risk standard for physical and psychological injury, but addition of contrast dye or sedation increases the risks, according to a report published in the September-October issue of IRB: Ethics & Human Research.
Matthias H. Schmidt, M.D., from the Dalhousie University in Halifax, Canada, and colleagues investigated whether pediatric MRI meets the minimal-risk standard based on the risk analysis of Canadian research ethic boards (REB) and considering the Tri-Council Policy Statement. Minimal-risk was defined as the level of risk an individual would normally accept in their daily life. The physical and psychological risks of MRI, as well as those associated with use of contrast dyes and sedation were evaluated.
The authors reported that the risk of physical injury and death from MRI was 17 per 100,000 and 4 per 100 million examinations, respectively. These risks meet the minimal-risk standard, assuming effective safety procedures are used. Children undergoing MRI reported feeling disturbed by the confined space, and bothered by the noise (12 and 16 percent, respectively), similar to levels of anxiety experienced in daily life. Only a small proportion of children (1.2 percent) were unable to complete the scan due to claustrophobia. The risk of local and minor systemic reactions from MRI contrast-enhancing agents was comparable to the risk following routine vaccination, whereas the risk of anaphylaxis was higher. Complications following MRI with sedation ranged from gastrointestinal complaints to more serious hazards such as respiratory and cardiac compromise.
"We urge researchers and REBs to collaborate in the ongoing effort to minimize the risk of harm and discomfort associated with pediatric MRI research," the authors write.
Full Text (subscription or payment may be required)