Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Primary Purpose
Postoperative Pain, Thyroidectomy, Cyclooxygenase 2 Inhibitors
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
celecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring celecoxib, postoperative pain, thyroidectomy
Eligibility 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.
Sites / Locations
- Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
No Intervention
Arm Label
2
1
Arm Description
placebo celecoxib
1 placebo
Outcomes
Primary Outcome Measures
The patients' total amount of morphine requirement in the first 24 hour.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00520338
Brief Title
Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Official Title
Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Thyroidectomy, Cyclooxygenase 2 Inhibitors
Keywords
celecoxib, postoperative pain, thyroidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
celecoxib
Arm Title
1
Arm Type
No Intervention
Arm Description
1 placebo
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
celebrex
Intervention Description
placebo
celecoxib 400 mg oral single dose
Primary Outcome Measure Information:
Title
The patients' total amount of morphine requirement in the first 24 hour.
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong, MD
Organizational Affiliation
Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
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