Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery
This study has been completed.
Sponsor:
Ullevaal University Hospital
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
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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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00373464
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
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016