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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520338
• Other study ID #: Si 117/2007
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2007
• Last updated: November 6, 2010
• Start date: August 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cyclooxygenase 2 Inhibitors
• Pain, Postoperative
• Postoperative Pain
• Thyroidectomy

Intervention

Drug:
• celecoxib
placebo celecoxib 400 mg oral single dose

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patients' total amount of morphine requirement in the first 24 hour.		24 hour	Yes