Iopentol (Imagopaque 300) compared with iohexol (Omnipaque 300) and diatrizoate (Urografin 292) in pediatric urography. A clinical trial assessing adverse events and diagnostic information.

Abstract

A double-blind, parallel-group trial was performed in 96 children in order to evaluate and compare the safety and efficacy of iopentol (Imagopaque, Nycomed imaging AS, Oslo, Norway) with those of routinely used contrast media. Ten children below 1 year of age received iopentol and eight received iohexol (Omnipaque, Nycomed Imaging AS, Oslo, Norway) (both 300 mg I/ml) in a random manner. Seventy-eight children (39 in each group), between one and 10 years of age, received iopentol 300 or diatrizoate (Urografin, Schering AG, Berlin, Germany) 292 mg I/ml for urography. No adverse events were observed among the children below 1 year of age. In the group between one and 10 years there was a statistically and clinically significant difference (p = 0.007) in the incidence of adverse events between the iopentol (2.6%) and diatrizoate (25.6%) groups. All adverse events were of mild or moderate intensity. No serious reactions were encountered. The overall quality of visualization was judged to be diagnostic for all patients. This study supports the use of non-ionic contrast media in pediatric patients and confirms that iopentol is a safe and effective contrast medium well suited for children from 0-10 years of age.