Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 6, 2005
September 6, 2005
December 2004
Not Provided
  • The primary end points were morphine consumption within 24-hr post-operatively
  • and total pain relief over 8 h (TOPAR8).
Same as current
No Changes Posted
Patient global response to therapy
Same as current
Not Provided
Not Provided
 
Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain
A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2005
Not Provided

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
Female
15 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00149253
acute pain service, Faculty of Medicine,KhonKaenU
Not Provided
Not Provided
Khon Kaen University
Not Provided
Principal Investigator: waraporn chau-in, Asso Prof. Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand
Khon Kaen University
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP