Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age
Status:
Completed
Trial end date:
2019-07-19
Target enrollment:
Participant gender:
Summary
Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24
hours after Dotarem injection. Patients will be monitored for any adverse events that occur
for 2 hours following the completion of the MRI exam. The type of event, time of onset,
duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not
related, probably related, related, definitely related, unclassifiable), and subsequent
outcome (required treatment, favorable outcome, recovery with sequela, or death) will be
documented. Parents will be given instruction sheets on who and when to call should any
adverse event occur after discharge. Parents will be called by the radiology department the
next day to identify any adverse events that occurred during the first 24 hours after
discharge from the hospital.
Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be
compared to the combined pre- and post-contrast images following administration of Dotarem by
radiologists who are blinded to the patients' clinical information to assess for improvement
of image quality and delineation of structures with contrast.