Abstract

BackgroundDiscomfort characterized by pain and warmth are common adverse effects associated with the use of intra-arterial iodinated contrast media (CM). The objective of this review was to pool patient-reported outcomes available from head-to-head randomized controlled trials (RCTs) and to compare the discomfort rates associated with iso-osmolar contrast media (IOCM; i.e., iodixanol) to those reported with various low-osmolar contrast media (LOCM).MethodsA review of the literature published between 1990 and 2009 available through Medline, Medline Preprints, Embase, Biological s, BioBase, Cab s, International Pharmaceutical s, Life Sciences Collection, Inside Conferences, Energy Database, Engineering Index and Technology Collection was performed to compare rates of discomfort associated with the use of the IOCM (iodixanol) vs. various LOCM agents in head-to-head RCTs. All trials with a Jadad score ≥2 that reported patient discomfort data following intra-arterial administration of CM were reviewed, coded, and extracted.ResultsA total of 22 RCTs (n = 8087) were included. Overall discomfort (regardless of severity) was significantly different between patients receiving IOCM and various LOCMs (risk difference [RD] -0.049; 95% confidence interval [CI]: -0.076, -0.021; p = 0.001). IOCM was favored over all LOCMs combined with a summary RD value of -0.188 (95% CI: -0.265, -0.112; p < 0.001) for incidence of pain, regardless of severity. A greater reduction in the magnitude of pain was observed with IOCM (iodixanol), particularly with selective limb and carotid/intracerebral procedures. Similarly, the meta-analysis of warmth sensation, regardless of severity, favored IOCM over LOCMs with an RD of -0.043 (95% CI: -0.074, -0.011; p = 0.008). A positive linear relationship was observed between the discomfort effect size and age and a negative relationship with increasing proportion of women. The opposite trends were observed with warmth sensation.ConclusionsIOCM was associated with less frequent and severe patient discomfort during intra-arterial administration. These data support differences in osmolality as a possible determinant of CM discomfort.

Highlights

  • Discomfort characterized by pain and warmth are common adverse effects associated with the use of intra-arterial iodinated contrast media (CM)

  • The goals of the current study were to pool data available from head-to-head randomized controlled trials (RCTs) and compare the frequency and severity of discomfort associated with iso-osmolar contrast media (IOCM) to those reported with various low-osmolar contrast media (LOCM) agents

  • Fifty-one abstracts excluded for the following reasons: 17 studies were preclinical, involved skin testing, hemodynamic assessment, oral hydration, comparative technologies, or had no patient reported outcomes; 13 studies did not use IOCM, were not head-to-head IOCM versus LOCM, or were not blinded; 11 studies used IV administration; and 10 were meta-analysis and review articles

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Summary

Introduction

Discomfort characterized by pain and warmth are common adverse effects associated with the use of intra-arterial iodinated contrast media (CM). The objective of this review was to pool patient-reported outcomes available from head-to-head randomized controlled trials (RCTs) and to compare the discomfort rates associated with iso-osmolar contrast media (IOCM; i.e., iodixanol) to those reported with various low-osmolar contrast media (LOCM). MOsm/kg, to low-osmolar contrast media (LOCM) with a range of ~600-800 mOsm/kg, to iso-osmolal contrast media (IOCM) at 290 mOsm/kg that is isotonic to blood [1]. The intensity and frequency of adverse-effects associated with intravascular CM injections were reduced considerably with changes in usage from HOCM to LOCM. More than a third of patients in controlled clinical trials have been known to report CM-injection-related discomfort, local pain and an intense, unpleasant sensation of warmth [3]. It is of clinical value to further improve patient comfort and the diagnostic quality of radiological images [4]

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