IOPENTOL (IMAGOPAQUE(R)-300) COMPARED WITH IOHEXOL (OMNIPAQUE(R)-300)AND DIATRIZOATE (UROGRAFIN(R)-292) IN PEDIATRIC UROGRAPHY - A CLINICAL-TRIAL ASSESSING ADVERSE EVENTS AND DIAGNOSTIC INFORMATION

A double-blind, parallel-group trial was performed in 96 children in o rder to evaluate and compare the safety and efficacy of iopentol (Imag opaque(R), Nycomed Imaging AS, Oslo, Norway) with those of routinely u sed contrast media, Ten children below 1 year of age received iopentol and eight received iohexol (Omnipaque(R), Nycomed Imaging AS, Oslo, N orway) (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(R), Schering AG, Berlin, Germany) 292 mg I/ml for urography. No adverse events were observed among the childre n 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 diatri zoate (25.6%) groups. All adverse events were of mild or moderate inte nsity. No serious reactions were encountered. The overall quality of v isualization was judged to be diagnostic for all patients. This study supports the use of non-ionic contrast media in pediatric patients con firms that iopentol is a safe and effective contrast medium well suite d for children from 0-10 years of age.