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Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00565682
Enrollment
60
Registered
2007-11-30
Start date
2006-04-30
Completion date
2006-12-31
Last updated
2007-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis, Laparoscopic Surgery for Ovarian Cysts

Brief summary

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.

Interventions

etoricoxib 120 mg, tablet, orally, OD

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Hospital Vozandez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
To measure the amount of rescue medication (opioid) needed to reliefEvery hour after surgery

Secondary

MeasureTime frame
To determine the overall analgesic effect using the visual analog scale (VAS)Every hour after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026