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Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373464
First Posted: September 8, 2006
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
University of Oslo
Information provided by:
Oslo University Hospital
  Purpose
The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.

Condition Intervention Phase
Hysterectomy Tubal Excision Ovariectomy Postoperative Pain Drug: etoricoxib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Gynaecologic Surgery With Expected Need of Post-operative Opioids

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Equal opioid consumption in both groups postoperatively

Secondary Outcome Measures:
  • Equal visual analogue scale (VAS) and verbal rating scale (VRS) in the first 4 hours

Estimated Enrollment: 126
Study Start Date: March 2006
Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (American Society of Anaesthesiologists [ASA] I and II) due for elective, laparoscopic gynaecologic surgery with the expected need for post-operative opioids: hysterectomy, removal of tube(s) and/or ovarium.
  • Written informed consent.
  • Weight between 50 and 120 kg.

Exclusion Criteria:

  • Patients who use nonsteroidal anti-inflammatory agents (NSAIDs) in the last 48 hours (h) before surgery or are allergic to NSAIDs. Patients using steroids, anti-emetic drugs, or opioids in the last 48 h before surgery.
  • Sensitivity to the study drug or its components.
  • Cardiovascular risk conditions: heart failure, unstable hypertension, coronary artery disease (i.e. angina, previous myocardial infarction, previous coronary artery bypass surgery).
  • Cerebrovascular disease.
  • Other applicable exclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373464


Locations
Norway
Ullevaal University Hospital
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Merck Sharp & Dohme Corp.
University of Oslo
Investigators
Study Director: Johan Ræder, Prof.MD,PhD Ullevaal University Hospital
Principal Investigator: Harald Lenz, MD Ullevaal University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00373464     History of Changes
Other Study ID Numbers: 2005-003078-92
First Submitted: September 6, 2006
First Posted: September 8, 2006
Last Update Posted: July 1, 2011
Last Verified: August 2005

Keywords provided by Oslo University Hospital:
Postoperative pain
Opioid
Etoricoxib
Ketorolac
Laparoscopic Surgery
Surgical Procedures, Gynecologic

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents