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.
OBJECTIVE
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.


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%).


CONCLUSIONS
The IOCM iodixanol caused significantly less frequent injection-associated pain and heat sensation than the LOCM iomeprol during femoral arteriography.
Manke
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Universität Regensburg, Regensburg, Germany.
Marcus
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C
Page
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Puey
J
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Batakis
O
O
Fog
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D015901:Angiography, Digital Subtraction; D003287:Contrast Media / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging*; D006358:Hot Temperature; D006801:Humans; D007269:Injections, Intra-Arterial / Q000009:adverse effects; D007479:Iopamidol / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D010146:Pain / Q000139:chemically induced / Q000209:etiology*; D010147:Pain Measurement; D011446:Prospective Studies; D014283:Triiodobenzoic Acids / Q000009:adverse effects
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C057937:iomeprol; C044834:iodixanol; D007479:Iopamidol