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

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain; Thyroidectomy; Cyclooxygenase 2 Inhibitors

Intervention: celecoxib (Drug)

Phase: Phase 4

Status: Completed

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

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information

Starting date: August 2007
Last updated: November 6, 2010

Page last updated: August 20, 2015

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