MRIs and Children: What Is the Appropriate Use?
Medical ethicists have been grappling with the use of magnetic resonance imaging (MRI) for pediatric clinical trials. They have been trying to clarify how MRIs can meet the “minimal-risk standard” used by ethics committees to determine if a study is permitted to proceed.
The side effects of MRIs have been clear, but until the publication of a study in IRB: Ethics & Human Research, it wasn’t clear what factors contributed to the diagnostic tool’s problems overwhelming its utility.
The study concluded that the risks of physical and psychological harm to a child undergoing an MRI are no greater than the risks associated with a healthy child’s everyday activities. The problem comes in the form of the intravenous contrast dye or sedation sometimes used in conjunction with the MRI – they increase the odds of harm to an unacceptably high degree.
MRI is a popular diagnostic device because it affords exceptional views into the human body. The physical risks involve its strong magnetic force, and the psychological harm most often comes in the form of anxiety. The procedure can be claustrophic, noisy and time-consuming.
To parse the problems with MRIs, researchers examined the risks from MRI alone, and those attendant to using contrast-enhancing agents and sedation in conjunction with it. They found that:
- The risk of physical injury from MRI was 17 in 100,000 examinations, and the risk of death was 4 in 100 million examinations.
- The risk of injury in children younger than 16 was 4 in 100,000 hours of playing soccer, and 12,730 in 100,000 hours of playing ice hockey.
- The risk of death from riding in a motor vehicle for children younger than 14 was 6 in 100 million car trips, and for teens from 15 to 19, 40 in 100 million.
Assuming that an MRI examination lasts an hour, the risk of injury associated with an MRI falls within the lower end of this range, the authors write.
Psychological harm in children between 10 and 18 included:
- being disturbed by the confined space, about 1 in 10;
- being bothered by the noise, about 15 in 100;
- being unable to complete the MRI scan because of claustrophobia, 1 in 100.
The rates were lower on average than those of children who report fears associated with anxiety disorders; in one study of children between 8 and 13, nearly half reported fears associated with subclinical anxiety and 1 in 5 met the full criteria of an anxiety disorder.
When an MRI examination calls for the injection of a contrast dye, the risk is allergic reaction, such as fever, headache and anaphylaxis (airway constriction, heart abnormalities). The risk of minor reactions from MRI contrast dyes was about 5 in 100, which is comparable to the risk of minor reactions from routine vaccinations. The risk of anaphylaxis was 7.5 in 100,000 doses; that’s higher than the risk of anaphylaxis from vaccinations. “MRI with contrast enhancement therefore does not meet the minimal-risk standard,” concluded the researchers.
They also concluded that the risk from sedation in MRIs, which includes gastrointestinal complaints and motor imbalance, does not meet the minimal-risk standard, based on the risks posed by sedating medications such as over-the-counter cold medicines.
MRI is a valuable diagnostic tool. But in refining its application, we're starting to see, again, how a child is not an adult.
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