Pain Post Abdominal Laparoscopy Prevention With Arcoxia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Laparoscopic Surgery for Appendicitis Laparoscopic Surgery for Cholecystitis Laparoscopic Surgery for Ovarian Cysts	Drug: etoricoxib 120 mg	Phase IV

MedlinePlus related topics:

Appendicitis Ovarian Cysts

ChemIDplus related topics:

Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Further study details as provided by Hospital Vozandez:

Primary Outcome Measures:

To measure the amount of rescue medication (opioid) needed to relief [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the overall analgesic effect using the visual analog scale (VAS) [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	April 2006
Study Completion Date:	December 2006

Arms	Assigned Interventions
A: Experimental Etoricoxib 120 mg	Drug: etoricoxib 120 mg etoricoxib 120 mg, tablet, orally, OD

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565682

Sponsors and Collaborators

Hospital Vozandez

Merck

Investigators


Principal Investigator:	Eduardo Noboa, MD	Hospital Vozandez

More Information

Responsible Party:	Hospital Vozandez ( Eduardo Noboa )
Study ID Numbers:	DOLAAR
First Received:	November 29, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00565682
Health Authority:	Ecuador: Public Health Ministry

Study placed in the following topic categories:

Gallbladder Diseases

Gonadal Disorders

Gastrointestinal Diseases

Etoricoxib

Endocrine System Diseases

Cholecystitis

Pain

Ovarian Diseases

Cysts

Intestinal Diseases

Genital Diseases, Female

Digestive System Diseases

Acalculous Cholecystitis

Appendicitis

Biliary Tract Diseases

Endocrinopathy

Gastroenteritis

Ovarian Cysts

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Cyclooxygenase Inhibitors

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Cecal Diseases

Adnexal Diseases

Neoplasms

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2008

Sponsors and Collaborators:	Hospital Vozandez Merck
Information provided by:	Hospital Vozandez
ClinicalTrials.gov Identifier:	NCT00565682