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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 February 27, 2015