Laparoscopic Surgery for Appendicitis Clinical Trial
Official title:
Pain Post Abdominal Laparoscopy Prevention With Arcoxia
| Verified date | November 2007 |
| Source | Hospital Vozandez |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ecuador: Public Health Ministry |
| Study type | Interventional |
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Voluntary acceptance to participate in the study and signed the informed consent form - Age older than 18 years old and younger than 70 years - Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery Exclusion Criteria: - Age less than 18 years or older than 70 years. - Laparoscopic procedures for diagnostic purposes. - Current use of anticoagulants. - Known hypersensitivity to etoricoxib or its components. - History of a CABG or MI (less than 1 year) - History of unstable angina (over the past six months). - Current inflammatory bowel disease. - Uncontrolled hypertension or heart failure - Renal dysfunction/impairment (creatinine clearance < 30ml/min) - Cirrhosis or severe hepatic dysfunction - Any degree of dehydration (mild to severe) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Vozandez | Merck Sharp & Dohme Corp. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To measure the amount of rescue medication (opioid) needed to relief | Every hour after surgery | No | |
| Secondary | To determine the overall analgesic effect using the visual analog scale (VAS) | Every hour after surgery | No |