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 < 0.05). Secondary outcomes showed similar rescue analgesic administration and adverse effects. There was no serious adverse event. Conclusion Ketorolac at 10‐, 20‐, and 30‐mg doses can produce similar analgesic efficacy in renal colic.
BackgroundAcute low back pain (LBP) is a common complaint in the emergency department and achieving effective analgesia can be challenging.MethodsIn this multicentre randomised double-blind clinical trial conducted at three EDs in Iran from August to November 2020, we assessed the efficacy and adverse effects of two muscle relaxants in patients aged 18 years or older who suffered LBP in the last 6 weeks. Group 1 received intravenous methocarbamol and group 2 received intravenous diazepam followed by a weight-based dose of intravenous morphine in both groups. Exclusion criteria mainly included non-spine aetiologies, cord compression, acute gastrointestinal bleeding, renal/hepatic insufficiency, pregnancy, breast feeding and unstable vital signs. Pain scores and adverse events were measured by a Numeric Rating Scale (NRS) at baseline and after 30 and 60 min by one of the researchers who was not involved with patient visits and was blinded to the intervention. We usedt-test to assess the mean difference of NRS at 30 and 60 min.ResultsOut of 101 enrolled patients, 50 participants received methocarbamol and 51 diazepam. The baseline mean pain scores and demographic characteristics were not different between the study groups. Pain scores were reduced by both agents after 60 min, with slightly greater pain reductions in the diazepam group in comparison with methocarbamol (mean difference −6.1, 95% CI −6.5 to −5.7 vs mean difference −5.2, 95% CI –5.7 to −4.7, respectively, p<0.001). ED length of stay of patients did not differ between the groups (methocarbamol 5.9 vs diazepam 4.8 hours, p=0.365). Patients receiving diazepam were more likely to report drowsiness (2 (4.0%) vs 15 (29.4%), p=0.001).ConclusionsIn patients with LBP, the pain was relieved in the methocarbamol and diazepam groups after 60 min. Although diazepam was more effective, its use was associated with a slightly higher risk of drowsiness.Trial registration numberThe protocol of this clinical trial was prospectively registered in the irct.ir (IRCTID: IRCT20151113025025N4;https://irct.ir/trial/50148) .
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