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Pain Post Abdominal Laparoscopy Prevention With Arcoxia

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Hospital Vozandez
ClinicalTrials.gov Identifier:
NCT00565682
First received: November 29, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: A
Etoricoxib 120 mg
 Drug: etoricoxib 120 mg
etoricoxib 120 mg, tablet, orally, OD
Other Name: Arcoxia

  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

No publications provided

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

Additional relevant MeSH terms:
Appendicitis
Cholecystitis
Acalculous Cholecystitis
Ovarian Cysts
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Gallbladder Diseases
Biliary Tract Diseases
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013