Image quality and safety in pediatric urography using an ionic and a non-ionic iodinated contrast agent.

The safety and diagnostic efficacy of the new non-ionic, monomeric contrast medium iopentol (Imagopaque) were evaluated and compared with those of the ionic medium metrizoate (Isopaque), in urography in children in a randomized, double-blind, parallel study. The trial comprised 59 children aged from 3 months to 8 years; children with predefined risk factors were not included. The difference in attenuation between the renal and perirenal tissue, assessed from film density measurements, was chosen as the main variable. Diagnostic efficacy was also evaluated subjectively from demarcation of the kidney and the pelvic structures. There was no statistically significant difference between the groups in the diagnostic efficacy. Serious adverse events did not occur in either group. Mild to moderate, transient adverse events were significantly less frequent in the iopentol group than in the metrizoate group, but in no case was medical treatment required. There were no changes or trends toward changes of clinical importance in either group, in serum chemistry variables measured in blood samples taken 2 min after injection of contrast medium compared to baseline values.

RCT Entities:   Population Interventions Outcomes