Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

Phase 3

Completed

• Conditions: a Single-Dose of Etoricoxib; Post-Operative Morphine Consumption; Total Pain Relief Over 8 Hr(TOPAR8); Post Transabdominal Hysterectomy

• Registration Number: NCT00149253
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2004-10
• Study Start: 2004-12
• Study Completion: 2005-05
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Last Update Submitted: 2005-09-06
• Study First Posted: 2005-09-08
• Last Update Posted: 2005-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary end points were morphine consumption within 24-hr post-operatively
and total pain relief over 8 h (TOPAR8).

Secondary Outcome Measures

Name	Time	Method
Patient global response to therapy

Trial Locations

Locations (1)

Warporn Chau-in; 🇹🇭 KhonKaen University, KhonKaen, Thailand