[Iomeprol: results of clinical trials with a new nonionic contrast medium in children].

PURPOSE

To assess the tolerability of the newly developed nonionic contrast medium Iomeprol in pediatric patients.

MATERIAL AND METHODS

A total of 438 patients (1 day-17 years) were enrolled in open-label phase III studies with Iomeprol in the most important radiologic, urologic, and cardiologic indications. Iomeprol was tested in five concentrations ranging from isotonic solutions of 150 mg iodine/ml up to 400 mg iodine/ml. Half of the patients were younger than 3 years.

RESULTS

Apart from the mostly slight sensations of heat, pain, and taste, the following adverse events were observed independently of a causal relationship to the test compound: vomiting (1.8%), rise in blood pressure (1.8%), and restlessness (1.1%). The respective incidence of all other adverse events was below 1%.

CONCLUSION

Iomeprol is a suitable and well-tolerated nonionic contrast medium for use in pediatric examinations.