Clinical tolerance and diagnostic efficacy of iobitridol in contrast-enhanced CT in children.
OBJECTIVE
The purpose of this double-blind, randomized parallel trial was to evaluate and compare the clinical safety and the diagnostic efficacy of the new nonionic triiodinated contrast agent iobitridol (300 mg I/ml) with those of iohexol (300 mg I/ml) in CT examinations in children.


METHODS
Eighty children of either sex were included in the study. Of those, 40 patients received iobitridol, 40 iohexol. Mean volume injected i.v. was 1.8 ml/kg b.w. Adverse reactions occurring during 24 hours after the injection of the contrast agent were recorded.


RESULTS
Image quality was judged good or excellent in all study examinations and all were diagnostically informative. There was no significant difference in clinical safety between the 2 groups and only adverse reactions of mild or moderate intensity were reported in both groups.


CONCLUSIONS
Iobitridol appears to be a safe, well tolerated and effective contrast agent, when used for brain and body CT in children.
Smets
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A
Departments of Pediatric Radiology, University Hospital, Gent, Belgium.
Shaw
D
D
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014057:Tomography, X-Ray Computed
D003287:Contrast Media; C093233:iobitridol; D007472:Iohexol