Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

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ClinicalTrials.gov Identifier: NCT01859585

Recruitment Status : Completed

First Posted : May 22, 2013

Last Update Posted : May 22, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

KOOPONG SIRIBUMRUNGWONG, MD, Prince of Songkla University

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

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Study Type :	Interventional (Clinical Trial)
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 :	March 2011
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Non-Drug Pain Management

Drug Information available for: Ketorolac

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Parecoxib Parecoxib	Drug: Parecoxib Parecoxib 40 mg intravenous Other Name: Dynastat
Experimental: Ketorolac Ketorolac	Drug: Ketorolac Ketorolac 30 mg intravenous Other Name: Ketolac
No Intervention: No medication No medication

Outcome Measures

Primary Outcome Measures :

Pain score [ Time Frame: Postoperative time up to 24 hours ]
recorded as Verbal Numerical Rating Scare 0-10

Secondary Outcome Measures :

Total amount of opioid consumption postoperatively [ Time Frame: Postoperative 24 hours ]

Other Outcome Measures:

Amount of drain output and Other Adverse effect [ Time Frame: 7 days postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859585

Locations

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Thailand
Faculty of Medicine, Prince of Songkla University
Hadyai, Sonkla, Thailand, 90110

Sponsors and Collaborators

Prince of Songkla University

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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 Key Record Dates
Last Update Posted:	May 22, 2013
Last Verified:	May 2013

Keywords provided by KOOPONG SIRIBUMRUNGWONG, MD, Prince of Songkla University:


preemptive analgesia lumbar fusion Parecoxib Ketorolac

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Ketorolac Parecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics	Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors

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