TY - JOUR
T1 - A multi-centre randomised double-blind placebo-controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT colonography
AU - Boellaard, Thierry N.
AU - van der Paardt, Marije P.
AU - Hollmann, Markus W.
AU - Eberl, Susanne
AU - Peringa, Jan
AU - Schouten, Lex J.
AU - Kavaliauskiene, Giedre
AU - Runge, Jurgen H.
AU - Tielbeek, Jeroen A. W.
AU - Stoker, Jaap
PY - 2013
Y1 - 2013
N2 - 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. 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. 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. 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. Dutch Trial Register: NTR2902
AB - 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. 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. 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. 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. Dutch Trial Register: NTR2902
U2 - https://doi.org/10.1186/1471-230X-13-94
DO - https://doi.org/10.1186/1471-230X-13-94
M3 - Article
C2 - 23706123
SN - 1471-230X
VL - 13
SP - 94
JO - BMC gastroenterology
JF - BMC gastroenterology
IS - 1
ER -