Document Detail


Comparison in myelography between iodixanol 270 and 320 mgI/ml and iotrolan 300 mgI/ml: a multicentre, randomised, parallel-group, double-blind, phase III trial.
MedLine Citation:
PMID:  11870488     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The objective of the trial was to compare the safety and efficacy of the non-ionic, dimeric, isotonic contrast medium iodixanol (Visipaque 270 and 320 mgI/ml) with those of iotrolan (Isovist 300 mgI/ml) in myelography. After lumbar or cervical puncture, 315 patients were examined in a multicentre, double-blind, randomised, comparative myelography study. Image quality, changes in vital signs, immediate and delayed adverse events were registered. There was a tendency for better images with iodixanol 320 than with iodixanol 270 and iotrolan 300, but the overall quality was good or excellent with all products. The frequency of patients reporting adverse events and headache varied much across centres, but there was no statistically significant difference between the contrast media. The incidence of events was higher after lumbar puncture than after cervical puncture, in women rather than in men, and after puncture with a 22-gauge (G) bevel-tipped needle compared with a 24 G Sprotte needle. The frequency of headache did not correlate with the absence of pathology. The higher iodine concentration in iodixanol 320 could be an advantage for film quality. When compared with iotrolan 300, iodixanol 320 and 270 give similar incidences of adverse events, including headache.
Authors:
Yvan Palmers; Fritz-Peter Kuhn; Dirk Petersen; Danielle De Greef
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2001-05-09
Journal Detail:
Title:  European radiology     Volume:  12     ISSN:  0938-7994     ISO Abbreviation:  Eur Radiol     Publication Date:  2002 Mar 
Date Detail:
Created Date:  2002-02-28     Completed Date:  2002-04-12     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9114774     Medline TA:  Eur Radiol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  686-91     Citation Subset:  IM    
Affiliation:
Ziekenhuis Oost-Limburg, Campus St Jan, Department of Medical Imaging, Schiepse Bos 6, 3600 Genk, Belgium. yvan.palmers@zol.be
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MeSH Terms
Descriptor/Qualifier:
Contrast Media / administration & dosage,  adverse effects*
Double-Blind Method
Female
Headache / chemically induced
Humans
Iodine / administration & dosage,  diagnostic use
Male
Middle Aged
Myelography / adverse effects
Radiographic Image Enhancement
Sex Factors
Spinal Cord Diseases / radiography
Spinal Puncture / instrumentation
Tomography, X-Ray Computed
Triiodobenzoic Acids / administration & dosage,  adverse effects*
Chemical
Reg. No./Substance:
0/Contrast Media; 0/Triiodobenzoic Acids; 7553-56-2/Iodine; 79770-24-4/iotrolan; 92339-11-2/iodixanol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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