NCT01859585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2011

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

May 15, 2013

Last Update Submit

May 21, 2013

Conditions

Postoperative Pain

Keywords

preemptive analgesialumbar fusionParecoxibKetorolac

Outcome Measures

Primary Outcomes (1)

  • Pain score

    recorded as Verbal Numerical Rating Scare 0-10

    Postoperative time up to 24 hours

Secondary Outcomes (1)

  • Total amount of opioid consumption postoperatively

    Postoperative 24 hours

Other Outcomes (1)

  • Amount of drain output and Other Adverse effect

    7 days postoperatively

Study Arms (3)

Parecoxib

EXPERIMENTAL

Parecoxib

Drug: Parecoxib

Ketorolac

EXPERIMENTAL

Ketorolac

Drug: Ketorolac

No medication

NO INTERVENTION

No medication

Interventions

ParecoxibDRUG

Parecoxib 40 mg intravenous

Also known as: Dynastat
Parecoxib
KetorolacDRUG

Ketorolac 30 mg intravenous

Also known as: Ketolac
Ketorolac

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing lumbar spinal fusion for one to three levels
  • ASA class I or II

You may not qualify if:

  • History of allergy to Sulfa group
  • History of allergy to OPOID or NSAIDs
  • Contraindicate to NSAIDs use
  • History of coagulopathy or platelet disfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hadyai, Sonkla, 90110, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 25886746DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxibKetorolac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Koopong Siribumrungwong, MD

    Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparing the efficacy of Parecoxib and Ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 22, 2013

Study Start

March 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

TH(1)