Injection-associated pain in femoral arteriography: a European multicenter study comparing safety, tolerability, and efficacy of iodixanol and iopromide.
OBJECTIVE
To evaluate injection-associated pain, safety, and efficacy with the isotonic contrast medium iodixanol (Visipaque 270 mg I/ml) compared with iopromide (Ultravist 300 mg I/ml) in femoral arteriography.


METHODS
A multicenter, double-blind, randomized, parallel-group clinical investigation was carried out in 54 hospitals in Europe. Of the patients evaluated, 1225 received iodixanol and 1227 iopromide in conventional and/or digital subtraction angiography.


RESULTS
The iodixanol group reported statistically significantly less injection-associated pain (0.9%) than the iopromide group (9.5%) (p << 0.001). Further, 4.1% in the iodixanol group experienced pain and/or severe heat sensation vs 19. 8% in the iopromide group (p << 0.001). In the iodixanol group, 1.8% of the patients experienced contrast-related adverse events vs 2.4% in the iopromide group (p = NS). Overall diagnostic information was optimal for 94.1% in the iodixanol group and 95.3% in the iopromide group (p = NS).


CONCLUSIONS
Iodixanol 270 mg I/ml causes significantly less injection-associated pain during femoral arteriography and is as safe and efficacious as iopromide 300 mg I/ml.
Justesen
P
P
Department of Radiology, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense, Denmark.
Downes
M
M
Grynne
B H
BH
Lang
H
H
Rasch
W
W
Seim
E
E
D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging*; D006801:Humans; D007269:Injections, Intra-Arterial / Q000009:adverse effects*; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced*; D011859:Radiography; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; C038192:iopromide; C044834:iodixanol