Procedural pain treatment with transmucosal sublingual fentanyl tablet in colonoscopy patients

Abstract

Colonoscopy is considered an invasive procedure that causes remarkable pain and discomfort to the patient. Colonoscopy can be performed successfully without sedation, but sedation can be used to decrease anxiety and analgesia during the colonoscopy. Most often sedation and analgesia are achieved by administering intravenous benzodiazepine and opioid. The purpose of this study was to evaluate the efficacy of sublingually administered fentanyl to placebo in patients having colonoscopy. Male and female patients aged 18 to 80 years scheduled to undergo a routine diagnostic or therapeutic colonoscopy were eligible to the study. Patients were excluded if they had had previous gastrointestinal surgery. Colonoscopy patients were randomized to receive a sublingual fentanyl tablet (Abstral ® 100 µg, ProStrakan) or placebo sublingual tablet ten minutes before the procedure. The procedure was assessed by the nurse and the surgeon performing the procedure and also by the patient. Patients assessed adverse effects of opioids (nausea/drowsiness), pain and the unpleasantness of the procedure. Sedation, co-operation, nausea and whether the patient seemed to have pain were all assessed by both the nurse and the surgeon. They evaluated also their overall satisfaction with the procedure and the surgeon also evaluated technical difficulties with colonoscopy. The patients were interviewed by telephone on the first day after the procedure. They assessed anxiety before procedure and how well they could remember events during and after the colonoscopy. Patients were also asked whether they had stomach pain or opioid adverse effects(drowsiness/nausea/dizziness) during the day after the procedure. The study showed that colonoscopy can be performed as successfully without analgesia as using the 100µg sublingual fentanyl tablet. There was no difference in patient’s experience of pain or self-assessed sedation levels between the intervention and placebo groups. Administration of the drug had no significant effect on the endoscopist’s performance. This study also showed that the dose of 100 micrograms sublingual fentanyl is safe to use and it does not cause sedation or prolong hospital stay. In conclusion sublingual fentanyl, at least as a monotherapy, seems to be ineffective for the preparation of patients undergoing to colonoscopy. It remains to be elucidated whether a combination of fentanyl with a benzodiazepine would be more effective, equally safe, and able to eliminate the need for deeper sedation during colonoscopy.