Comparison of intravenous ketorolac at three doses for treating renal colic in the emergency department: A noninferiority randomized controlled trial

ABSTRACT Background Ketorolac tromethamine is a nonsteroidal anti‐inflammatory drug (NSAID) that is extensively used for the management of renal colic in the emergency department (ED). It has been proposed that ketorolac is used at doses above its analgesic ceiling with no more advantages and increased risk of adverse effects. In this study, we compared the analgesic effects of three doses of intravenous ketorolac in patients with renal colic. Methods This noninferiority, randomized, double‐blind clinical trial evaluated the analgesic efficacy of three doses of intravenous ketorolac (10, 20, and 30 mg) in adult patients presenting to the ED with renal colic. Exclusion criteria consisted of age > 65 years, active peptic ulcer disease, acute gastrointestinal hemorrhage, renal or hepatic insufficiency, NSAID hypersensitivity, pregnancy or breastfeeding, unstable vital signs, and patients who had received analgesics in the past 24 hours. Pain was recorded every 15 minutes from baseline up to 60 minutes, and the primary outcome was pain reduction at 30 minutes. If patients still required additional pain medications at 30 minutes, they would receive 0.1 mg/kg intravenous morphine sulfate as a rescue analgesic. Results A total of 165 subjects enrolled in this study, 55 in each group. The median visual analog scale score in 30 minutes was improved from 90 at baseline to 40 among subjects who were randomized to 30‐mg group. This improvement was 40 and 50 mm in 20‐ and 10‐mg ketorolac treatment arms, respectively, with no significant difference between the three doses (p