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Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

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ClinicalTrials.gov Identifier: NCT00149253
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 8, 2005
Sponsor:
Information provided by:
Khon Kaen University

Brief Summary:
Taken together, studies of the value of pre-emptive analgesia are inconclusive. This randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia.

Condition or disease Intervention/treatment Phase
a Single-Dose of Etoricoxib Post-Operative Morphine Consumption Total Pain Relief Over 8 Hr(TOPAR8) Post Transabdominal Hysterectomy Drug: a single-dose of Etoricoxib before induction of anesthesia Phase 3

Detailed Description:
Patients undergoing transabdominal hysterectomy were randomized to a group taking a single dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2 hours before surgery under the same standardized general anesthesia. At the post-anesthetic care unit, intravenous morphine titration was given before starting self-controlled analgesia (PCA) device. Morphine consumption, pain relief score, sedative score, global evaluation score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. The primary end points were morphine consumption within 24-hr post-operatively and total pain relief over 8 h (TOPAR8). Patient global satisfaction was also assessed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy
Study Start Date : December 2004
Estimated Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources




Primary Outcome Measures :
  1. The primary end points were morphine consumption within 24-hr post-operatively
  2. and total pain relief over 8 h (TOPAR8).

Secondary Outcome Measures :
  1. Patient global response to therapy


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The ASA I or II patients undergoing elective transabdominal hysterectomy with general anesthesia

Exclusion Criteria:

  • Patients with history of opioid addiction or chronic pain
  • Allergy to other nonsteroidal anti-inflammatory, or asthma
  • Concomitant use of tricyclic antidepressants, opioid analgesics, antihistamines, tranquilizers, hypnotics, sedatives, or systemic corticosteroids
  • Those unable to understand the principle of patient-controlled analgesia(PCA) device were excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149253


Locations
Thailand
Warporn Chau-in
KhonKaen University, KhonKaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: waraporn chau-in, Asso Prof. Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand

ClinicalTrials.gov Identifier: NCT00149253     History of Changes
Other Study ID Numbers: acute pain service
Faculty of Medicine,KhonKaenU
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 8, 2005
Last Verified: October 2004

Keywords provided by Khon Kaen University:
Abdominal hysterectomy,
Etoricoxib,
morphine consumption,
pre-emptive analgesia

Additional relevant MeSH terms:
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents