Back to resultsEfficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Parecoxib
Ketorolac
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring preemptive analgesia, lumbar fusion, Parecoxib, Ketorolac
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing lumbar spinal fusion for one to three levels
- ASA class I or II
Exclusion Criteria:
- History of allergy to Sulfa group
- History of allergy to OPOID or NSAIDs
- Contraindicate to NSAIDs use
- History of coagulopathy or platelet disfunction
Sites / Locations
- Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Parecoxib
Ketorolac
No medication
Arm Description
Parecoxib
Ketorolac
No medication
Outcomes
Primary Outcome Measures
Pain score
recorded as Verbal Numerical Rating Scare 0-10
Secondary Outcome Measures
Total amount of opioid consumption postoperatively
Full Information
NCT ID
NCT01859585
First Posted
May 15, 2013
Last Updated
May 21, 2013
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01859585
Brief Title
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
Official Title
Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
preemptive analgesia, lumbar fusion, Parecoxib, Ketorolac
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parecoxib
Arm Type
Experimental
Arm Description
Parecoxib
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Ketorolac
Arm Title
No medication
Arm Type
No Intervention
Arm Description
No medication
Intervention Type
Drug
Intervention Name(s)
Parecoxib
Other Intervention Name(s)
Dynastat
Intervention Description
Parecoxib 40 mg intravenous
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Ketolac
Intervention Description
Ketorolac 30 mg intravenous
Primary Outcome Measure Information:
Title
Pain score
Description
recorded as Verbal Numerical Rating Scare 0-10
Time Frame
Postoperative time up to 24 hours
Secondary Outcome Measure Information:
Title
Total amount of opioid consumption postoperatively
Time Frame
Postoperative 24 hours
Other Pre-specified Outcome Measures:
Title
Amount of drain output and Other Adverse effect
Time Frame
7 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing lumbar spinal fusion for one to three levels
ASA class I or II
Exclusion Criteria:
History of allergy to Sulfa group
History of allergy to OPOID or NSAIDs
Contraindicate to NSAIDs use
History of coagulopathy or platelet disfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koopong Siribumrungwong, MD
Organizational Affiliation
Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hadyai
State/Province
Sonkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
25886746
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
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