title: Injection-associated pain in femoral arteriography: a European multicenter study comparing safety, tolerability, and efficacy of iodixanol and iopromide.
abstract: 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.
authors.affiliation: Department of Radiology, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense, Denmark.
authors.forename: P
authors.initials: P
authors.lastname: Justesen
authors.forename: M
authors.initials: M
authors.lastname: Downes
authors.forename: B H
authors.initials: BH
authors.lastname: Grynne
authors.forename: H
authors.initials: H
authors.lastname: Lang
authors.forename: W
authors.initials: W
authors.lastname: Rasch
authors.forename: E
authors.initials: E
authors.lastname: Seim
mesh_terms: 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*
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; C038192:iopromide; C044834:iodixanol