Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial - Full Text View

Sponsor:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00520338

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Celecoxib Thyroid

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator placebo celecoxib	Drug: celecoxib placebo celecoxib 400 mg oral single dose
1: No Intervention 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:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520338

Contacts

Contact: Sirilak Suksompong, MD

6624113256

sisuk@mahidol.ac.th

Locations

Thailand
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University	Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD 6624113256 sisuk@mahidol.ac.th
Principal Investigator: Sirilak Suksompong, MD

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:	Mahidol University ( Sirilak Suksompong )
Study ID Numbers:	Si 117/2007
Study First Received:	August 22, 2007
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00520338 History of Changes
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Mahidol University:

celecoxib
postoperative pain
thyrooidectomy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Pain
Enzyme Inhibitors
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010