Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

Postoperative Pain Clinical Trial

Official title:

Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859585
• Other study ID #: PSU-0001
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2013
• Last updated: May 21, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Parecoxib
Parecoxib 40 mg intravenous
• Ketorolac
Ketorolac 30 mg intravenous

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hadyai	Sonkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of drain output and Other Adverse effect		7 days postoperatively	Yes
Primary	Pain score	recorded as Verbal Numerical Rating Scare 0-10	Postoperative time up to 24 hours	Yes
Secondary	Total amount of opioid consumption postoperatively		Postoperative 24 hours	Yes