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

November 6, 2010 updated by: Mahidol University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
  1. placebo
  2. celecoxib
Drug: celecoxib
  1. placebo
  2. celecoxib 400 mg oral single dose
Other Names:
  • celebrex
No Intervention: 1
1 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The patients' total amount of morphine requirement in the first 24 hour.
Time Frame: 24 hour
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Sirilak Suksompong, MD, Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 6, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 117/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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