British Journal of Anaesthesia, 2002, Vol. 88, No. 2 227-233
© 2002 The Board of Management and Trustees of the British Journal of Anaesthesia
Clinical Investigations |
Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery
1Department of Anaesthesia, McMaster University, Hamilton, Canada. 2Department of Anaesthesia, Vrije Universiteit, Brussels, Belgium. 3Department of Obstetrics and Gynaecology, University of Glasgow, Glasgow, UK. 4Department of Surgical Gastroenterology, University of Copenhagen, Hvidovre, Denmark. 5Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK. 6Department of Anaesthesia, Hôpital Tenon, Paris, France. 7Department of Primary Care and Population Sciences and Department of Social Medicine, University of Bristol, Bristol, UK. 8Department of Haematology, University of Barcelona, Barcelona, Spain. 9Department of Anaesthesia, Universität Mainz, Mainz, Germany. 10Department of Pharmacology, University of Verona, Verona, Italy. 11Department of Medicine, Birmingham University, Birmingham, UK. 12Department of Gastroenterology, L.Sacco University Hospital, Milan, Italy. 13Department of Haematology, University Hôpital-Dieu de Paris, Paris, France. 14Ckdt Communications Ltd, Allschwil, Switzerland*Corresponding author: Department of Anaesthesia, HSC 2U4, McMaster University, Hamilton, Canada L8N 3Z5
Declaration of interest. This study was funded by F. Hoffmann-La Roche Ltd.
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.
Br J Anaesth 2002; 88: 227–33
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