Iomeprol in computed axial tomography of the brain: phase II study in children

Safety and effectiveness of a new non-ionic contrast medium (CM), iomeprol (300 mg I/ml), were evaluated in children undergoing cranial CT. The results of an open phase II clinical trial are reported. Fifty inpatients (aged 1 month to 14 years) were enrolled and the CM was administered intravenously as a bolus injection (mean total volume between 6 and 90 ml). No clinically important changes in vital parameters or laboratory tests were detected and the mean values after procedure were inside 95% confidence intervals of the preinvestigation mean basal values. Neither ECG nor EEG were modified. Contrast effectiveness was scored as good or excellent on 48 occasions, and adequate on 2. Mild hypotension and tachycardia occurred in 2 patients. These results in paediatric patients confirm the previous data from adults and suggest a good tolerability as well as efficacy of iomeprol.