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Completed

NCT Number: NCT01859585

Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Prince of Songkla University

Hadyai, Sonkla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parecoxib

Drug

Parecoxib 40 mg intravenous

Other names: Dynastat

Ketorolac

Drug

Ketorolac 30 mg intravenous

Other names: Ketolac

Primary outcomes

  1. Pain score

    Time frame: Postoperative time up to 24 hours

    recorded as Verbal Numerical Rating Scare 0-10

Secondary outcomes

  1. Total amount of opioid consumption postoperatively

    Time frame: Postoperative 24 hours

Other outcomes

  1. Amount of drain output and Other Adverse effect

    Time frame: 7 days postoperatively

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 22, 2013
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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