Status:
COMPLETED
Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
University of Oslo
Conditions:
Hysterectomy
Tubal Excision
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
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 th...
Detailed Description
Postoperative pain can contribute to reduce the patient well-being and, if it is pronounced, delay rehabilitation and increase the total cost for nursing and treatment. As quite extensive surgical pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00373464
Start Date
March 1 2006
End Date
March 1 2007
Last Update
July 1 2011
Active Locations (1)
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1
Ullevaal University Hospital
Oslo, Oslo County, Norway