Overview

Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
Female
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 the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ullevaal University Hospital
Collaborators:
Merck Sharp & Dohme Corp.
University of Oslo
Treatments:
Etoricoxib
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.