Document Detail


Comparative study of analgesic efficacy and morphine-sparing effect of intramuscular dexketoprofen trometamol with ketoprofen or placebo after major orthopaedic surgery.
MedLine Citation:
PMID:  12580983     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: Multimodal analgesia is thought to produce balanced and effective postoperative pain control. A combined therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and opiates could result in synergistic analgesia by acting through different mechanisms. Currently there are very few parenterally administered NSAIDs suitable for the immediate postoperative period. Therefore, this study was undertaken to assess the analgesic efficacy, relative potency, and safety of parenteral dexketoprofen trometamol following major orthopaedic surgery.
METHODS: One hundred and seventy-two patients elected for prosthetic surgery, were randomized to receive two intramuscular injections (12 hourly) of either dexketoprofen 50 mg, ketoprofen 100 mg or placebo in a double-blind fashion. Postoperatively, the patient's pain was stabilized, then they were connected to a patient- controlled analgesia system (PCA) of morphine for 24 h (1 mg with 5 min lockout).
RESULTS: The mean cumulative amount of morphine (CAM) used was of 39 mg in the dexketoprofen group and 45 mg in the ketoprofen group vs 64 mg in the placebo group. (Reduction in morphine use was approximately one-third between the active compounds compared with placebo (adjusted mean difference of -25 mg between dexketoprofen and placebo and -23 mg between ketoprofen and placebo. These differences were statistically significant: P </= 0.0003; 95% CI -35, -14. Pain-intensity scores were consistently lower with the active compounds, the lowest corresponded to the dexketoprofen-treated patients. Regarding sedation, there were statistically significant differences between the two active compounds and placebo only at the 2nd and 13th hours. Wound bleeding was specifically measured with no statistically significant differences found between all the groups.
CONCLUSIONS: Intramuscular administration of dexketoprofen trometamol 50 mg has good analgesic efficacy both in terms of opioid-sparing effect and control of pain after major orthopaedic surgery.
Authors:
M H Hanna; K M Elliott; M E Stuart-Taylor; D R Roberts; D Buggy; G J Arthurs
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  55     ISSN:  0306-5251     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-02-12     Completed Date:  2003-04-28     Revised Date:  2013-06-09    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  126-33     Citation Subset:  IM    
Affiliation:
King's College Hospital, Pain Research Unit, London, UK. magdi.hanna@kcl.ac.uk
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Analgesics, Opioid / administration & dosage*
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
Female
Humans
Injections, Intramuscular
Ketoprofen / administration & dosage*,  analogs & derivatives*
Male
Middle Aged
Morphine / administration & dosage*
Pain, Postoperative / prevention & control*
Treatment Outcome
Tromethamine / administration & dosage*,  analogs & derivatives*
Chemical
Reg. No./Substance:
0/Analgesics, Opioid; 0/Anti-Inflammatory Agents, Non-Steroidal; 22071-15-4/Ketoprofen; 57-27-2/Morphine; 77-86-1/Tromethamine; N674F7L21E/dexketoprofen trometamol
Comments/Corrections
Erratum In:
Br J Clin Pharmacol. 2010 Feb; 69(2):218

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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