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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Cyclooxygenase 2 Inhibitors; Thyroidectomy

Treatments: Drug: celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT00520338

Si 117/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

1. placebo 2. celecoxib

Treatment:

Drug: celecoxib

1

No Intervention group

Description:

1 placebo