A double blind clinical study comparing the safety, tolerance and efficacy of ioversol 240 and iohexol 240 (Omnipaque 240) in ascending venography.
A randomised, double blind, parallel group study was performed comparing the efficacy, tolerance and safety of ioversol-240 and iohexol-240 (Omnipaque-240) in 50 patients undergoing venography. Adult patients of either sex, 18 years of age or older, who were referred to the Department of Radiology at Northwick Park Hospital, Harrow, England, for ascending venography were study candidates. There were 25 patients in each drug group, who were comparable in relation to age, sex, weight, height and race. The drug groups were comparable with respect to contrast volume and iodine dose administered. All film sets were rated as diagnostic and the patient groups were comparable with respect to quality of procedure. The incidence of patients reporting heat and pain as a result of the injection of contrast medium was minimal and comparable in the drug groups. Safety was assessed by monitoring vital signs (blood pressure, pulse and respiration), clinical laboratory studies and observation of adverse effects prior to and after injection of contrast medium. Vital signs remained stable in all study patients. There were no abnormal post-procedural laboratory data which were judged to have been drug related. There were no drug related adverse effects in either group. It is concluded that ioversol-240 is a safe, well-tolerated and effective contrast agent when used for venography.
Department of Radiology, Northwick Park Hospital, Harrow, Middlesex.
R A
RA
Wilkins
B C
BC
Spinks
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006358:Hot Temperature; D006801:Humans; D007275:Injections, Intravenous / Q000009:adverse effects; D007463:Iodobenzoates; D007472:Iohexol / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D011674:Pulse / Q000187:drug effects; D011859:Radiography; D016032:Randomized Controlled Trials as Topic; D013924:Thrombophlebitis / Q000000981:diagnostic imaging*; D014283:Triiodobenzoic Acids / Q000009:adverse effects
D003287:Contrast Media; D007463:Iodobenzoates; D014283:Triiodobenzoic Acids; D007472:Iohexol; C054871:ioversol