The Benefit of Fentanyl in Effective Sedation and Quality of Upper Endoscopy: A Double-Blinded Randomized Trial of Fentanyl Added to Midazolam Versus Midazolam Alone for Sedation

Our goals were to compare the effect of adding fentanyl to midazolam in a double-blinded, randomized, placebo-controlled trial and determine if fentanyl enhances sedation, increases adverse events or effects time of the procedure or discharge. Patients 18 to 65 years scheduled for outpatient upper endoscopy were eligible for the study. Patients were randomized to receive either 100 mcg/2 mL of Fentanyl or 2 mL of placebo IV with a double-blinded protocol. All patients received 2 mg of intravenous midazolam initially. Additional midazolam could be given to achieve adequate sedation. There were 68 patients randomized to the Fentanyl group and 69 patients to the placebo group. The mean dose of midazolam was 4.0 mg for the Fentanyl group and 5.2 mg for placebo group (P=0.003). Both endoscopist and nurse independently rated sedation to be better in the fentanyl group (P=0001). The patient did not perceive any difference in sedation (P=0.4). Procedure time was significantly shorter in the Fentanyl group (8.5 versus 11.1 minutes, P=0.001), with no difference in the discharge time. There was significantly less retching observed in patients in the fentanyl group (P<0.001). There were no major complications. Endoscopists and nurses found adding fentanyl significantly improved sedation, led to a shorter procedure time, and allowed for less midazolam to be used per case. It did not affect the patient experience of sedation and was safe. Fentanyl use for routine outpatient upper endoscopy should be considered as a safe option to improve procedural sedation. NCT:01514695 (www.clinicaltrials.gov) Accepted as an abstract for the Canadian Digestive Diseases Week meeting in February 2014.