A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- a Single-Dose of Etoricoxib
- Sponsor
- Khon Kaen University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The primary end points were morphine consumption within 24-hr post-operatively
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
The primary end points were morphine consumption within 24-hr post-operatively
and total pain relief over 8 h (TOPAR8).
Secondary Outcomes
- Patient global response to therapy