IOPENTOL (IMAGOPAQUE(R)-350) COMPARED WITH IOHEXOL (OMNIPAQUE(R)-350)IN PEDIATRIC CARDIOANGIOGRAPHY - A CLINICAL-TRIAL ASSESSING ADVERSE EVENTS, ECG, BLOOD-PRESSURE AND DIAGNOSTIC INFORMATION

A non-ionic, monomeric, low-osmolar contrast medium, iopentol (Imagopa que(R), Nycomed Imaging aging AS, Oslo, Norway) has been compared with iohexol (Omnipaque(R), Nycomed Imaging AS, Oslo, Norway) in a double- blind, randomized, parallel-group trial in children. The aims of the s tudy were to compare the safety and radiographic efficacy of iopentol 350 mg I/ml versus those of iohexol 350 mg I/ml in pediatric cardioang iography. Seventy-three children, of whom 35 received iopentol and 35 iohexol, were included in the evaluation. The quality of overall diagn ostic information was excellent or adequate in all patients. There wer e no statistically significant differences between numbers of patients reporting adverse events nor number of patients reporting discomfort in the two groups. Three patients in iopentol group and two patients i n the iohexol group reported adverse events. Heat sensation was report ed by 4 patients in the iopentol group and 5 patients in the iohexol g roup. Following injection of contrast medium, there were no difference s between the groups regarding ECG, heart rate and systolic. blood pre ssure at the site of injection. Iopentol was demonstrated to be as eff ective, safe and well tolerated as iohexol in pediatric cardioangiogra phy.