A double-blind CT study comparing the safety and efficacy of iopentol and ioxaglate in paediatric patients.

Iopentol (Imagopaque); 300 mg I/ml was compared with ioxaglate (Hexabrix; 320 mg I/ml in 89 patients (45 and 44 patients, mean age 8.5 and 7.9 years in the contrast groups, respectively), in paediatric intravenous CT contrast enhancement. The dose injected was 2 ml/kg b.w. with an upper limit of 100 ml. There was a total of 18 patients who reported adverse events other than sensations of heat or cold, 6 (13%) in the iopentol group and 12 (27%) in the ioxaglate group. Two patients (4%) in the iopentol group reported possible contrast-related events as described above, whereas the number was 8 (18%) in the ioxaglate group. There was no statistically significant difference between the two groups regarding adverse events, blood pressure, nor heart rate changes after injection. The overall quality of CT enhancement was excellent or sufficient in 96 and 93% of the cases in the iopentol and ioxaglate groups, respectively. Iopentol was shown to be a safe and effective contrast medium in examinations of children.

RCT Entities:   Population Interventions Outcomes