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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014