Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain - Full Text View

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00149253

Purpose

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.

Condition	Intervention	Phase
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	Phase III

MedlinePlus related topics: Anesthesia Hysterectomy

Drug Information available for: Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Patient global response to therapy

Estimated Enrollment:	50
Study Start Date:	December 2004
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149253

Locations

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

Sponsors and Collaborators

Khon Kaen University

Investigators

Principal Investigator:

waraporn chau-in, Asso Prof.

Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand

More Information

Study ID Numbers:	acute pain service, Faculty of Medicine,KhonKaenU
Study First Received:	September 6, 2005
Last Updated:	September 6, 2005
ClinicalTrials.gov Identifier:	NCT00149253
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Khon Kaen University:

Abdominal hysterectomy,
Etoricoxib,
morphine consumption,
pre-emptive analgesia

Study placed in the following topic categories:

Morphine
Etoricoxib
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009