Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

September 6, 2005 updated by: Khon Kaen University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • KhonKaen
      • KhonKaen University, KhonKaen, Thailand, 40002
        • Warporn Chau-in

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Patient global response to therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: waraporn chau-in, Asso Prof., Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

September 8, 2005

Last Update Submitted That Met QC Criteria

September 6, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • acute pain service
  • Faculty of Medicine,KhonKaenU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on a Single-Dose of Etoricoxib

Clinical Trials on a single-dose of Etoricoxib before induction of anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe