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Pain Post Abdominal Laparoscopy Prevention With Arcoxia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565682
First Posted: November 30, 2007
Last Update Posted: November 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Hospital Vozandez
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • To determine the overall analgesic effect using the visual analog scale (VAS) [ Time Frame: Every hour after surgery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565682


Sponsors and Collaborators
Hospital Vozandez
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Eduardo Noboa, MD Hospital Vozandez
  More Information

Responsible Party: Eduardo Noboa, Hospital Vozandez
ClinicalTrials.gov Identifier: NCT00565682     History of Changes
Other Study ID Numbers: DOLAAR
First Submitted: November 29, 2007
First Posted: November 30, 2007
Last Update Posted: November 30, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Appendicitis
Cholecystitis
Acalculous Cholecystitis
Ovarian Cysts
Intraabdominal Infections
Infection
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents