Journal Article

A multi-centre randomised double-blind placebo-controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT colonography

Stoker, Jaap, Schouten, Lex J, Kavaliauskiene, Giedre, Tielbeek, Jeroen AW, Runge, Jurgen H, van der Paardt, Marije P, Boellaard, Thierry N, Peringa, Jan, Hollmann, Markus W, Eberl, Susanne

2013

Overview

Background Pain is common during colonic insufflation required for CT colonography. We therefore evaluate whether a single intravenous alfentanil bolus has a clinically relevant analgesic effect compared with placebo in patients undergoing CT colonography. Methods A prospective multi-centre randomised double-blind placebo-controlled trial was performed in patients scheduled for elective CT colonography. Patients were randomised to receive either a bolus of 7.5 μg/kg alfentanil (n = 45) or placebo (n = 45). The primary outcome was the difference in maximum pain during colonic insufflation on an 11-point numeric rating scale. We defined a clinically relevant effect as a maximum pain reduction of at least 1.3 points. Secondary outcomes included total pain and burden of CT colonography (5-point scale), the most burdensome aspect and side effects. Our primary outcome was tested using a one-sided independent samples t-test. Results Maximum pain scores during insufflation were lower with alfentanil as compared with placebo, 5.3 versus 3.0 ( P  < 0.001). Total CT colonography pain and burden were also lower with alfentanil (2.0 vs. 1.6; P  = 0.014 and 2.1 vs. 1.7; P  = 0.007, respectively). With alfentanil fewer patients rated the insufflation as most burdensome aspect (56.1% vs. 18.6%; P  = 0.001). Episodes with desaturations < 90% SpO2 were more common with alfentanil (8.1% vs. 44.4%; P  < 0.001, but no clinically relevant desaturations occurred. Conclusions A low-dose intravenous alfentanil bolus provides a clinically relevant reduction of maximum pain during CT colonography and may improve the CT colonography acceptance, especially for patients with a low pain threshold. Trial registration Dutch Trial Register: NTR2902

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Adolescent / Adult / Aged / Aged, 80 and over / Alfentanil / Alfentanil - administration & dosage / Analgesics, Opioid - administration & dosage / Analysis / Anesthesia Recovery Period / Anesthetics, Intravenous - administration & dosage / Care and treatment / Clinical medicine / Clinical trials / Colonography, Computed Tomographic - adverse effects / Colonoscopy / Colorectal cancer / Double-Blind Method / Gastroenterology / Hepatology / Humans / Injections, Intravenous / Internal Medicine / Medical screening / Medicine / Medicine & Public Health / Middle Aged / Monitoring, Physiologic / Pain / Pain - etiology / Pain - prevention & control / Patient safety / Patient satisfaction / Patients / Physicians / Prospective Studies / Research Article / Standard deviation / Surveys and Questionnaires / Teaching hospitals / Young Adult