Document Detail

Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery.
MedLine Citation:
PMID:  11883386     Owner:  NLM     Status:  MEDLINE    
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.
J B Forrest; F Camu; I A Greer; H Kehlet; M Abdalla; F Bonnet; S Ebrahim; G Escolar; J Jage; S Pocock; G Velo; M J S Langman; Porro G Bianchi; M M Samama; E Heitlinger;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  British journal of anaesthesia     Volume:  88     ISSN:  0007-0912     ISO Abbreviation:  Br J Anaesth     Publication Date:  2002 Feb 
Date Detail:
Created Date:  2002-03-06     Completed Date:  2002-04-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0372541     Medline TA:  Br J Anaesth     Country:  England    
Other Details:
Languages:  eng     Pagination:  227-33     Citation Subset:  IM    
Department of Anaesthesia, McMaster University, Hamilton, Canada.
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MeSH Terms
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / adverse effects*,  therapeutic use
Anticoagulants / adverse effects
Blood Loss, Surgical
Cyclooxygenase Inhibitors / adverse effects*
Diclofenac / adverse effects,  therapeutic use
Drug Hypersensitivity / etiology
Ketoprofen / adverse effects,  therapeutic use
Ketorolac / adverse effects*,  therapeutic use
Kidney Failure, Acute / etiology
Middle Aged
Pain, Postoperative / drug therapy*
Prospective Studies
Risk Factors
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anticoagulants; 0/Cyclooxygenase Inhibitors; 15307-86-5/Diclofenac; 22071-15-4/Ketoprofen; 66635-83-4/Ketorolac

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