Efficacy Parecoxib and Ketorolac as Preemptive Analgesia... | NCT01859585

Studies
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

NCT01859585

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

96Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Parecoxib
Ketorolac

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

May 15, 2013

First Submission Date that Met QC Criteria

May 21, 2013

First Posted Date

May 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2013

Last Update Posted Date

May 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

KOOPONG SIRIBUMRUNGWONG, MD, Comparing the efficacy of Parecoxib and Ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parecoxib	Experimental	Parecoxib	Drug: Parecoxib
Ketorolac	Experimental	Ketorolac	Drug: Ketorolac
No medication	No Intervention	No medication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parecoxib	Drug	Parecoxib 40 mg intravenous	Parecoxib	Dynastat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	recorded as Verbal Numerical Rating Scare 0-10	Postoperative time up to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Total amount of opioid consumption postoperatively		Postoperative 24 hours

Other Outcomes

Measure	Description	Time Frame
Amount of drain output and Other Adverse effect		7 days postoperatively

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Koopong Siribumrungwong, MD	Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Prince of Songkla University		Hadyai	Sonkla	90110	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25886746	Derived	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring