Postoperative PainPhase 4NCT01859585
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
A Phase 4 study testing Parecoxib and Ketorolac in people with Postoperative Pain, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Parecoxib and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Mar 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lumbar spinal fusion for one to three levels
- ASA class I or II
Who cannot join
- History of allergy to Sulfa group
- History of allergy to OPOID or NSAIDs
- Contraindicate to NSAIDs use
- History of coagulopathy or platelet disfunction
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hadyai, Sonkla, 90110
About this study
Official title: Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion
The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion.
Read the detailed description
A prospective, double-blinded randomized control trial. Randomly allocated patient undergoing posterior lumbar spinal fusion into 3 groups (n=32) to receive Parecoxib, Ketorolac and Placebo around 30 minutes prior to incised skin. Efficacy was assessed by visual analog scale score (0-10), total opioid consumption, complication and bleeding also recorded.
- Conditions
- Postoperative Pain
- Being tested
- Parecoxib, Ketorolac
- Keywords
- preemptive analgesia, lumbar fusion, Parecoxib, Ketorolac
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Also called Dynastat
Parecoxib 40 mg intravenous
KetorolacDrug
Also called Ketolac
Ketorolac 30 mg intravenous
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib | Experimental | Parecoxib Receives: Drug: Parecoxib |
| Ketorolac | Experimental | Ketorolac Receives: Drug: Ketorolac |
| No medication | No intervention | No medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
recorded as Verbal Numerical Rating Scare 0-10
Measured: Postoperative time up to 24 hours
Secondary outcomes (1)
Total amount of opioid consumption postoperatively
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KOOPONG SIRIBUMRUNGWONG, MD, Prince of Songkla University
- Investigators
- Koopong Siribumrungwong, MD, Principal investigator, Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859585
- Sponsor's protocol ID
- PSU-0001
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siribumrungwong K, Cheewakidakarn J, Tangtrakulwanich B, Nimmaanrat S. Comparing parecoxib and ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion: a prospective randomized double-blinded placebo-controlled trial. BMC Musculoskelet Disord. 2015 Mar 18;16:59. doi: 10.1186/s12891-015-0522-5.
PubMed 25886746
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion
- ClinicalTrials.gov ID
- NCT01859585
- Acronym / sponsor ID
- PSU-0001
- Conditions
- Postoperative Pain
- Keywords
- preemptive analgesia, lumbar fusion, Parecoxib, Ketorolac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 May 2013 (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 evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion.
Detailed description
A prospective, double-blinded randomized control trial. Randomly allocated patient undergoing posterior lumbar spinal fusion into 3 groups (n=32) to receive Parecoxib, Ketorolac and Placebo around 30 minutes prior to incised skin. Efficacy was assessed by visual analog scale score (0-10), total opioid consumption, complication and bleeding also recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Experimental | Drug: ParecoxibParecoxib |
| Ketorolac | Experimental | Drug: KetorolacKetorolac |
| No medication | No intervention | –No medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing lumbar spinal fusion for one to three levels
- ASA class I or II
Key exclusion criteria (4 listed)
- History of allergy to Sulfa group
- History of allergy to OPOID or NSAIDs
- Contraindicate to NSAIDs use
- History of coagulopathy or platelet disfunction
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 |
|---|---|---|
| ParecoxibAlso: DynastatParecoxib 40 mg intravenous | Drug | Parecoxib |
| KetorolacAlso: KetolacKetorolac 30 mg intravenous | Drug | Ketorolac |
Primary outcome
Pain score
Time frame: Postoperative time up to 24 hours
recorded as Verbal Numerical Rating Scare 0-10
1 secondary outcome
Total amount of opioid consumption postoperatively
Time frame: Postoperative 24 hours
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 22 May 2013.
- Derived from this study: PubMed 25886746Siribumrungwong K, Cheewakidakarn J, Tangtrakulwanich B, Nimmaanrat S. Comparing parecoxib and ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion: a prospective randomized double-blinded placebo-controlled trial. BMC Musculoskelet Disord. 2015 Mar 18;16:59. doi: 10.1186/s12891-015-0522-5.
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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.
Koopong Siribumrungwong, MD principal investigator
Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, 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 Parecoxib and Ketorolac in people with Postoperative Pain, run by Prince of Songkla 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 2 inclusion and 4 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 22 May 2013. 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. 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?
Pain score (time frame: Postoperative time up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859585, which also lists 1 linked publication.
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 22 May 2013.