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Pain Post Abdominal Laparoscopy Prevention With Arcoxia

This study has been completed.

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




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