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

Phase 4

Completed

• Conditions: Postoperative Pain; Thyroidectomy; Cyclooxygenase 2 Inhibitors
• Interventions: Drug: celecoxib

• Registration Number: NCT00520338
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-24
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-06
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	celecoxib	1. placebo 2. celecoxib

Primary Outcome Measures

Name	Time	Method
The patients' total amount of morphine requirement in the first 24 hour.	24 hour

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand