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

Abstract

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. This noninferiority, randomized, double-blind clinical trial evaluated the analgesic efficacy of three doses of intravenous ketorolac (10, 20, and 30mg) 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 15minutes from baseline up to 60minutes, and the primary outcome was pain reduction at 30minutes. If patients still required additional pain medications at 30minutes, they would receive 0.1mg/kg intravenous morphine sulfate as a rescue analgesic. 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-mggroup. This improvement was 40and 50mm in 20- and 10-mg ketorolac treatment arms, respectively, with no significant difference between the three doses (p<0.05). Secondary outcomes showed similar rescue analgesic administration and adverse effects. There was no serious adverse event. Ketorolac at 10-, 20-, and 30-mg doses can produce similar analgesic efficacy in renal colic.