SKOPE – Study of Ketorolac vs Opioid for Pain after Endoscopy: A Double-Blinded Randomized Control Trial in Patients Undergoing Ureteroscopy.
Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. We conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.Eighty-one patients were included (43 oxycodone, 38 ketorolac). The two groups had comparable patient, stone, and perioperative characteristics. No differences were found in post-operative pain scores, study medication or rescue pill usage, or side effects. Higher maximum pain scores on days 1-5 (p<0.05) and higher USSQ score (28.1 vs 21.7, p=0.045) correlated with analgesic usage, irrespective of treatment group. Patients receiving ketorolac reported significantly fewer days confined to bed (1.3±1.3 vs 2.3±2.6, p=0.02). There was no difference in unscheduled post-operative physician encounters.This is the first double-blinded RCT comparing NSAIDs and opiates post-URS and demonstrates non-inferiority of NSAIDs in pain control with similar efficacy, safety profile, physician contact and notably, earlier convalescence compared to the opioid group. This provides strong evidence against routine opioid use post-URS, justifying continued investigation into reducing post-operative opiate prescriptions.
Authors: Donald Fedrigon, Anna Faris, Naveen Kachroo, Rajat Jain, Marlie Elia, Lamont Wilkins, Jianbo Li, Smita De, Mark Noble, Manoj Monga, Sri Sivalingam