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

BMC Gastroenterology

Research Article

Susanne Eberl¹  Markus W Hollmann¹  Thierry N Boellaard²  Jurgen H Runge²  Marije P van der Paardt²  Lex J Schouten²  Jeroen AW Tielbeek²  Giedre Kavaliauskiene²  Jaap Stoker²  Jan Peringa³ 

[1] Department of Anaesthesiology, Academic Medical Center, University of Amsterdam, 1100 DD, Amsterdam, The Netherlands;Department of Radiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1100 DD, Amsterdam, The Netherlands;Department of Radiology, Onze Lieve Vrouwe Gasthuis, 1091 AC, Amsterdam, The Netherlands;

关键词: Randomised controlled trial;    Colonography;    Computed tomographic;    Alfentanil;    Analgesics;    Opioid;    Patient satisfaction;   

DOI  :  10.1186/1471-230X-13-94

 received in 2013-01-30, accepted in 2013-05-21,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundPain 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.MethodsA 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.ResultsMaximum 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.ConclusionsA 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 registrationDutch Trial Register: NTR2902

【 授权许可】

CC BY   
© Boellaard et al.; licensee BioMed Central Ltd. 2013