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

NCT ID: NCT00520338

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Thyroidectomy Cyclooxygenase 2 Inhibitors

Keywords

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celecoxib postoperative pain thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

1. placebo
2. celecoxib

Group Type PLACEBO_COMPARATOR

celecoxib

Intervention Type DRUG

1. placebo
2. celecoxib 400 mg oral single dose

1

1 placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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celecoxib

1. placebo
2. celecoxib 400 mg oral single dose

Intervention Type DRUG

Other Intervention Names

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celebrex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Mahidol University

Principal Investigators

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Sirilak Suksompong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand

Locations

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Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si 117/2007

Identifier Type: -

Identifier Source: org_study_id