Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

a Single-Dose of Etoricoxib Clinical Trial

Official title:

A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149253
• Other study ID #: acute pain service
• Secondary ID: Faculty of Medic
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: December 2004
• Est. completion date: May 2005

Study information

• Verified date: October 2004
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• a single-dose of Etoricoxib before induction of anesthesia

Locations

Country	Name	City	State
Thailand	Warporn Chau-in	KhonKaen University	KhonKaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end points were morphine consumption within 24-hr post-operatively
Primary	and total pain relief over 8 h (TOPAR8).
Secondary	Patient global response to therapy