Assessment of pain between sedated and unsedated colonoscopy: Double-blind randomized clinical trail

BACKGROUND: Colonoscopy plays a vital role for the diagnosis and treatment of colonic diseases but can be associated with anxiety and discomfort or pain. We tested whether unsedated colonoscopy impacts quality indicators and investigated predictors of pain during colonoscopy. MATERIALS AND METHODS: This randomized controlled trial was performed on candidates for elective colonoscopy at AL Zahra Hospital, Isfahan at 2018–2019. Balanced block randomization was used to allocate 275 cases into two groups. At finally, 124 patients in case and 122 patients in control group enrolled in analysis. Patients in the sedation group received midazolam with/out pethidine before colonoscopy. Pain intensity in rectal examination (PIREX), preprocedural anxiety, pain intensity during colonoscopy, hemodynamics, duration of colonoscopy, polyp detection rate, cecal intubation rate, bloating within 24 h after colonoscopy, and willingness to repeat colonoscopy were assessed and compared between two groups. RESULTS: Compared to the group with sedation, cecal intubation time was shorter and bloating was less frequent (7% vs. 16%, P = 0.02) in the unsedated group. There was no difference between the two groups regarding polyp detection rate, cecal detection rate, and willingness to repeat colonoscopy. Pain during rectal examination was significantly associated with pain during colonoscopy (P < 0.001, 95% confidence interval; 0.5–1.3). CONCLUSION: The assessment of pain intensity during rectal examination may help to identify patients who can benefit from sedation during colonoscopy. Colonoscopy with sedation does not seem to have a negative impact on colonoscopy quality indicators, and may even reduce cecal intubation time and bloating following procedure.