A randomised, double-blind trial of iomeprol and iopromide in intravenous excretory urography.

The aim of this double-blind, parallel group study was to compare the safety, tolerance and diagnostic efficacy of iomeprol 350 mgI/ml and iopromide 370 mgI/ml in 100 adult patients undergoing intravenous excretory urography. Fifty patients were randomised to receive 50 ml iomeprol 350 mgI/ml and 50 to receive 50 ml iopromide 370 mgI/ml. Intravenous administration of the contrast agents was always completed in 30 seconds. Images were obtained immediately after and 5, 10 and 15 min after completion of contrast medium injection. Nephrogram and pyelogram opacification quality was blindly graded according to a four point scale as follows: 0, nondiagnostic; 1, diagnostic but of limited quality; 2, diagnostic and of good quality; 3, fully diagnostic and of very good quality'. At the end of each individual patient study, the overall diagnostic quality of the procedure was reported as the sum of the scores attributed to each quality of nephrogram and pyelogram opacification quality on different images (0-4, nondiagnostic procedure; 4-8, diagnostic procedure; 9-12, excellent or good procedure). The tolerability of the test compounds was evaluated in terms of discomfort (heat and pain) associated with the injection of the test compounds. All patients were continuously monitored for adverse experiences for 1 h after completion of the urographic procedure. Reporting of untoward reactions was both spontaneous and elicited. The quality of the radiographs was judged as excellent or good in most cases, without significant differences between the two study groups. The distribution of scores of overall diagnostic quality of procedures was similar for the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)