Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

• Sponsor: Prince of Songkla University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01859585
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Parecoxib; Drug: Ketorolac	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parecoxib Parecoxib	Drug: Parecoxib; Parecoxib 40 mg intravenous; Other Names: Dynastat
Experimental: Ketorolac Ketorolac	Drug: Ketorolac; Ketorolac 30 mg intravenous; Other Names: Ketolac
No Intervention: No medication No medication

Outcome Measures

Primary Outcome Measures

1. Pain score [Postoperative time up to 24 hours]

   recorded as Verbal Numerical Rating Scare 0-10

Secondary Outcome Measures

1. Total amount of opioid consumption postoperatively [Postoperative 24 hours]

Other Outcome Measures

1. Amount of drain output and Other Adverse effect [7 days postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Prince of Songkla University	Hadyai	Sonkla	Thailand	90110

Sponsors and Collaborators

• Prince of Songkla University

Investigators

• Principal Investigator: Koopong Siribumrungwong, MD, Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: KOOPONG SIRIBUMRUNGWONG, MD, Comparing the efficacy of Parecoxib and Ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion, Prince of Songkla University
• ClinicalTrials.gov Identifier: NCT01859585
• Other Study ID Numbers: PSU-0001
• First Posted: May 22, 2013
• Last Update Posted: May 22, 2013
• Last Verified: May 1, 2013

• Keywords provided by KOOPONG SIRIBUMRUNGWONG, MD, Comparing the efficacy of Parecoxib and Ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion, Prince of Songkla University: preemptive analgesia; lumbar fusion; Parecoxib; Ketorolac
• Additional relevant MeSH terms: Pain, Postoperative; Ketorolac; Parecoxib

Study Results

No Results Posted as of May 22, 2013