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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
Sponsor:
Information provided by (Responsible Party):
KOOPONG SIRIBUMRUNGWONG, MD, Prince of Songkla University

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 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


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



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


Secondary Outcome Measures :
  1. Total amount of opioid consumption postoperatively [ Time Frame: Postoperative 24 hours ]

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


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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

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
Thailand
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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     History of Changes
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:
Ketorolac
Ketorolac Tromethamine
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
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