Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery


Forrest, JB; Camu, F; Greer, IA; Kehlet, H; Abdalla, M; Bonnet, F; Ebrahim, S; Escolar, G; Jage, J; Pocock, S; Velo, G; Langman, MJS; Porro, GB; Samama, MM; Heitlinger, E; (2002) Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. British journal of anaesthesia, 88 (2). pp. 227-233. ISSN 0007-0912 DOI: https://doi.org/10.1093/bja/88.2.227

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Abstract

Background. Ketorolac is approved for the relief of postoperative pain but concerns have been raised over a possible risk of serious adverse effects and death. Two regulatory reviews in Europe on the safety of ketorolac found the data were inconclusive and lacked comparison with other non-steroidal anti-inflammatory drugs. The aim of this study was to compare the risk of serious adverse effects with ketorolac vs diclofenac or ketoprofen in adult patients after elective major surgery. Methods. This prospective, randomized multicentre trial evaluated the risks of death, increased surgical site bleeding, gastrointestinal bleeding, acute renal failure, and allergic reactions, with ketorolac vs diclofenac or ketoprofen administered according to their approved parenteral and oral dose and duration of treatment. Patients were followed for 30 days after surgery. Results. A total of 11 245 patients completed the trial at 49 European hospitals. Of these, 5634 patients received ketorolac and 5611 patients received one of the comparators. 155 patients (1.38%) had a serious adverse outcome, with 19 deaths (0.17%), 117 patients with surgical site bleeding (1.04%), 12 patients with allergic reactions (0.12%), 10 patients with acute renal failure (0.09%), and four patients with gastrointestinal bleeding (0.04%). There were no differences between ketorolac and ketoprofen or diclofenac. Postoperative anticoagulants increased the risk of surgical site bleeding equally with ketorolac (odds ratio=2.65, 95% CI=1.51-4.67) and the comparators (odds ratio=3.58, 95% CI=1.93-6.70). Other risk factors for serious adverse outcomes were age, ASA score, and some types of surgery (plastic/ear, nose and throat, gynaecology, and urology). Conclusion. We conclude that ketorolac is as safe as ketoprofen and diclofenac for the treatment of pain after major surgery.

Item Type: Article
Keywords: analgesics non-opioid, diclofenac, analgesics non-opioid, ketoprofen, analgesics non-opioid, ketorolac, complications, Nonsteroidal antiinflammatory drugs, acute-renal-failure, parenteral ketorolac, tromethamine, hemostasis, damage, risk, Adult, Aged, Aged, 80 and over, Anti-Inflammatory Agents, Non-Steroidal, adverse effects, therapeutic use, Anticoagulants, adverse effects, Blood Loss, Surgical, Comparative Study, Cyclooxygenase Inhibitors, adverse effects, Diclofenac, adverse effects, therapeutic use, Drug Hypersensitivity, etiology, Female, Human, Ketoprofen, adverse effects, therapeutic use, Ketorolac, adverse effects, therapeutic use, Kidney Failure, Acute, etiology, Male, Middle Age, Pain, Postoperative, drug therapy, Prospective Studies, Risk Factors, Support, Non-U.S. Gov't
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
Faculty of Epidemiology and Population Health > Dept of Non-Communicable Disease Epidemiology
Research Centre: Centre for Global Non-Communicable Diseases (NCDs)
PubMed ID: 11883386
Web of Science ID: 173726500010
URI: http://researchonline.lshtm.ac.uk/id/eprint/16660

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