Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain; Thyroidectomy; Cyclooxygenase 2 Inhibitors
Intervention: celecoxib (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Sirilak Suksompong, MD, Principal Investigator, Affiliation: Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand
Overall contact:
Sirilak Suksompong, MD, Phone: 6624113256, Email: sisuk@mahidol.ac.th
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.
Clinical Details
Official title: Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The patients' total amount of morphine requirement in the first 24 hour.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sirilak Suksompong, MD, Phone: 6624113256, Email: sisuk@mahidol.ac.th
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand; Recruiting
Sirilak Suksompong, MD, Phone: 6624113256, Email: sisuk@mahidol.ac.th
Sirilak Suksompong, MD, Principal Investigator
Additional Information
Starting date: August 2007
Ending date: December 2009
Last updated: May 15, 2009
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