Postoperative PainPhase 4NCT00520338
Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
A Phase 4 study testing celecoxib in people with Postoperative Pain and Thyroidectomy, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Thyroidectomy, Cyclooxygenase 2 Inhibitors
- What is being tested?
- celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ASA physical status I-III.
- Scheduled for an elective thyroidectomy.
- Body weight > or = 40kg
- Can operate a patient-controlled analgesia (PCA) device.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
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.
Read the 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.
- Being tested
- celecoxib
- Keywords
- celecoxib, postoperative pain, thyroidectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called celebrex
- placebo
- celecoxib 400 mg oral single dose
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | 1. placebo
2. celecoxib Receives: Drug: celecoxib |
| 1 | No intervention | 1 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients' total amount of morphine requirement in the first 24 hour.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520338
- Sponsor's protocol ID
- Si 117/2007
- Status last verified
- Nov 2010
- First submitted
- 22 Aug 2007
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00520338
- Acronym / sponsor ID
- Si 117/2007
- Keywords
- celecoxib, postoperative pain, thyroidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: celecoxib1. placebo 2. celecoxib |
| 1 | No intervention | –1 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ASA physical status I-III.
- Scheduled for an elective thyroidectomy.
- Body weight > or = 40kg
- Can operate a patient-controlled analgesia (PCA) device.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxibAlso: celebrex1. placebo 2. celecoxib 400 mg oral single dose | Drug | 2 |
Primary outcome
The patients' total amount of morphine requirement in the first 24 hour.
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirilak Suksompong, MD principal investigator
Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing celecoxib in people with Postoperative Pain and Thyroidectomy, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patients' total amount of morphine requirement in the first 24 hour. (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.