Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00373464
First received: September 6, 2006
Last updated: June 30, 2011
Last verified: August 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00373464     History of Changes
Other Study ID Numbers: 2005-003078-92
Study First Received: September 6, 2006
Last Updated: June 30, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on November 20, 2014