[Iomeprol: results of clinical trials with a new nonionic contrast medium in children].
OBJECTIVE
To assess the tolerability of the newly developed nonionic contrast medium Iomeprol in pediatric patients.


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%.


CONCLUSIONS
Iomeprol is a suitable and well-tolerated nonionic contrast medium for use in pediatric examinations.
van Gessel
R
R
Bracco-Byk Gulden GmbH, Konstanz.
Möller
A
A
Schmiedel
E
E
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007479:Iopamidol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male
D003287:Contrast Media; C057937:iomeprol; D007479:Iopamidol
Iomeprol: Ergebnisse der klinischen Prüfungen mit einem neuen nichtionischen Kontrastmittel bei Kindern.