Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

This study has been completed.
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00149253
First received: September 6, 2005
Last updated: NA
Last verified: October 2004
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

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

Secondary Outcome Measures:
  • Patient global response to therapy

Estimated Enrollment: 50
Study Start Date: December 2004
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149253     History of Changes
Other Study ID Numbers: acute pain service, Faculty of Medicine,KhonKaenU
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Thailand: Food and Drug Administration

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

Additional relevant MeSH terms:
Anesthetics
Etoricoxib
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 21, 2014