Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion.

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Detailed Description

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Parecoxib

Group Type EXPERIMENTAL

Parecoxib

Intervention Type DRUG

Parecoxib 40 mg intravenous

Ketorolac

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

Ketorolac 30 mg intravenous

No medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parecoxib

Parecoxib 40 mg intravenous

Intervention Type DRUG

Ketorolac

Ketorolac 30 mg intravenous

Intervention Type DRUG

Other Intervention Names

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Dynastat Ketolac

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No