Back to results

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

Primary Purpose

Postoperative Pain, Thyroidectomy, Cyclooxygenase 2 Inhibitors

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

celecoxib

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring celecoxib, postoperative pain, thyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient ASA physical status I-III.
Scheduled for an elective thyroidectomy.
Body weight > or = 40kg
Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
Known hypersensitivity to morphine or sulfonamides.
History of hepatic dysfunction.
Creatinine clearance < 30ml/min.
History of bleeding tendency.
History of gastrointestinal bleeding or active peptic ulcer.
Known case of inflammatory bowel disease.
Patient with severe heart failure.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

No Intervention

Arm Label

Arm Description

placebo celecoxib

1 placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00520338

First Posted

August 22, 2007

Last Updated

November 6, 2010

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00520338

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Thyroidectomy, Cyclooxygenase 2 Inhibitors

Keywords

celecoxib, postoperative pain, thyroidectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo celecoxib

Arm Title

Arm Type

No Intervention

Arm Description

1 placebo

Intervention Type

Drug

Intervention Name(s)

celecoxib

Other Intervention Name(s)

celebrex

Intervention Description

placebo celecoxib 400 mg oral single dose

Primary Outcome Measure Information:

Title

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

Time Frame

24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient ASA physical status I-III. Scheduled for an elective thyroidectomy. Body weight > or = 40kg Can operate a patient-controlled analgesia (PCA) device. Exclusion Criteria: History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs. Known hypersensitivity to morphine or sulfonamides. History of hepatic dysfunction. Creatinine clearance < 30ml/min. History of bleeding tendency. History of gastrointestinal bleeding or active peptic ulcer. Known case of inflammatory bowel disease. Patient with severe heart failure.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sirilak Suksompong, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs