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Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial

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.
ClinicalTrials.gov Identifier: NCT00520338
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:
Mahidol University

Brief Summary:

The purpose of this study is to determine whether celecoxib is effective in the treatment postoperative pain after thyroidectomy.

The research hypothesis:

There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib or placebo.


Condition or disease Intervention/treatment Phase
Postoperative Pain Thyroidectomy Cyclooxygenase 2 Inhibitors Drug: celecoxib Phase 4

Detailed Description:

Postoperative pain has been concerned in the past few years by both the anesthesiologists ans the surgeons. COX2-inhibitors have played an important roles in postoperative pain with minimal side effects.

Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib and placebo.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Study Start Date : August 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 2
  1. placebo
  2. celecoxib
Drug: celecoxib
  1. placebo
  2. celecoxib 400 mg oral single dose
Other Name: celebrex
No Intervention: 1
1 placebo



Primary Outcome Measures :
  1. The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient ASA physical status I-III.
  2. Scheduled for an elective thyroidectomy.
  3. Body weight > or = 40kg
  4. Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

  1. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
  2. Known hypersensitivity to morphine or sulfonamides.
  3. History of hepatic dysfunction.
  4. Creatinine clearance < 30ml/min.
  5. History of bleeding tendency.
  6. History of gastrointestinal bleeding or active peptic ulcer.
  7. Known case of inflammatory bowel disease.
  8. Patient with severe heart failure.

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): NCT00520338


Locations
Thailand
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sirilak Suksompong, MD Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand

Responsible Party: Sirilak Suksompong, Mahidol University
ClinicalTrials.gov Identifier: NCT00520338     History of Changes
Other Study ID Numbers: Si 117/2007
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by Mahidol University:
celecoxib
postoperative pain
thyroidectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Celecoxib
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents