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Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT00373464
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : July 1, 2011
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
University of Oslo
Information provided by:
Oslo University Hospital

Study Description
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Brief Summary:
The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.

Condition or disease Intervention/treatment Phase
Hysterectomy Tubal Excision Ovariectomy Postoperative Pain Drug: etoricoxib Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Gynaecologic Surgery With Expected Need of Post-operative Opioids
Study Start Date : March 2006
Actual Study Completion Date : March 2007
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Primary Outcome Measures :
  1. Equal opioid consumption in both groups postoperatively

Secondary Outcome Measures :
  1. Equal visual analogue scale (VAS) and verbal rating scale (VRS) in the first 4 hours

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (American Society of Anaesthesiologists [ASA] I and II) due for elective, laparoscopic gynaecologic surgery with the expected need for post-operative opioids: hysterectomy, removal of tube(s) and/or ovarium.
  • Written informed consent.
  • Weight between 50 and 120 kg.

Exclusion Criteria:

  • Patients who use nonsteroidal anti-inflammatory agents (NSAIDs) in the last 48 hours (h) before surgery or are allergic to NSAIDs. Patients using steroids, anti-emetic drugs, or opioids in the last 48 h before surgery.
  • Sensitivity to the study drug or its components.
  • Cardiovascular risk conditions: heart failure, unstable hypertension, coronary artery disease (i.e. angina, previous myocardial infarction, previous coronary artery bypass surgery).
  • Cerebrovascular disease.
  • Other applicable exclusion criteria.
Contacts and Locations
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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): NCT00373464


Locations
Norway
Ullevaal University Hospital
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Merck Sharp & Dohme Corp.
University of Oslo
Investigators
Study Director: Johan Ræder, Prof.MD,PhD Ullevaal University Hospital
Principal Investigator: Harald Lenz, MD Ullevaal University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00373464     History of Changes
Other Study ID Numbers: 2005-003078-92
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: August 2005

Keywords provided by Oslo University Hospital:
Postoperative pain
Opioid
Etoricoxib
 Ketorolac
Laparoscopic Surgery
Surgical Procedures, Gynecologic

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
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
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents