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

Manke, Christoph and Marcus, C. and Page, A. and Puey, J. and Batakis, O. and Fog, A. (2003) 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. ACTA RADIOLOGICA, 44 (6). pp. 590-596. ISSN 0284-1851

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Abstract

Purpose: To compare the injection-associated pain and heat sensation after administration of the iso-osmolar contrast medium (IOCM) iodixanol (Visipaque(TM) 270 mg I/ml) and the low osmolar contrast medium (LOCM) iomeprol (Iomeron(TM) 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.

Item Type: Article
Uncontrolled Keywords: PHYSICOCHEMICAL PROPERTIES; PHASE-III; TOLERABILITY; IOPROMIDE; PARALLEL; CARDIOANGIOGRAPHY; IOPAMIDOL; contrast media; angiography; digital subtraction; controlled clinical trial
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Röntgendiagnostik
Depositing User: Dr. Gernot Deinzer
Date Deposited: 27 Aug 2021 09:44
Last Modified: 27 Aug 2021 09:44
URI: https://pred.uni-regensburg.de/id/eprint/38422

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