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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00520338
First received: August 22, 2007
Last updated: November 6, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Postoperative Pain
Thyroidectomy
Cyclooxygenase 2 Inhibitors
 Drug: celecoxib
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The patients' total amount of morphine requirement in the first 24 hour. [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sirilak Suksompong, Mahidol University
ClinicalTrials.gov Identifier: NCT00520338     History of Changes
Other Study ID Numbers: Si 117/2007
Study First Received: August 22, 2007
Last Updated: November 6, 2010
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
celecoxib
postoperative pain
thyroidectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Celecoxib
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
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

ClinicalTrials.gov processed this record on May 19, 2013