Pain in femoral arteriography. A double-blind, randomized, clinical study comparing safety and efficacy of the iso-osmolar iodixanol 270 mgI/ml and the low-osmolar iomeprol 300 mgI/ml in 9 European centers.

PURPOSE: To compare the injection-associated pain and heat sensation after administration of the iso-osmolar contrast medium (IOCM) iodixanol (Visipaque trade mark 270 mg I/ml) and the low osmolar contrast medium (LOCM) iomeprol (Iomeron trade mark 300 mg I/ml) in femoral arteriography. MATERIAL AND METHODS: 352 patients received iodixanol or iomeprol in a prospective, double-blind, randomized, parallel-group clinical trial. The first injection during femoral arteriography (DSA with automated stepping) was standardized. Injection-associated pain and heat sensation, efficacy and safety up to 72 h were evaluated. RESULTS: The iodixanol group reported significant less injection-associated pain than the iomeprol group after the first injection (7.4% vs. 17.6%; p = 0.007), and after all injections (11% vs. 19.4%; p = 0.045). Iodixanol caused less heat sensation after the first injection (p = 0.007) and after all injections (p = 0.029). Heat sensations in the iodixanol group were less intense after all injections (p < 0.0001). No difference was found between the groups regarding the frequency of patients having adverse reactions (5.1% vs. 4%). CONCLUSION: The IOCM iodixanol caused significantly less frequent injection-associated pain and heat sensation than the LOCM iomeprol during femoral arteriography.