title: A multi-centre randomised double-blind placebo-controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT colonography.
abstract: 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.
  
  
  BACKGROUND
  Dutch Trial Register: NTR2902.
authors.forename: Thierry N
authors.initials: TN
authors.lastname: Boellaard
authors.forename: Marije P
authors.initials: MP
authors.lastname: van der Paardt
authors.forename: Markus W
authors.initials: MW
authors.lastname: Hollmann
authors.forename: Susanne
authors.initials: S
authors.lastname: Eberl
authors.forename: Jan
authors.initials: J
authors.lastname: Peringa
authors.forename: Lex J
authors.initials: LJ
authors.lastname: Schouten
authors.forename: Giedre
authors.initials: G
authors.lastname: Kavaliauskiene
authors.forename: Jurgen H
authors.initials: JH
authors.lastname: Runge
authors.forename: Jeroen A W
authors.initials: JA
authors.lastname: Tielbeek
authors.forename: Jaap
authors.initials: J
authors.lastname: Stoker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015760:Alfentanil / Q000008:administration & dosage*; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D000762:Anesthesia Recovery Period; D018686:Anesthetics, Intravenous / Q000008:administration & dosage*; D023881:Colonography, Computed Tomographic / Q000009:adverse effects*; D004311:Double-Blind Method; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D008991:Monitoring, Physiologic; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D018686:Anesthetics, Intravenous; D015760:Alfentanil