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Clinical Trials/NCT02813018
NCT02813018
Completed
Not Applicable

The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery

Yonsei University1 site in 1 country50 target enrollmentJuly 7, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Surgical Patients
Sponsor
Yonsei University
Enrollment
50
Locations
1
Primary Endpoint
FLACC scale score (Face, Legs, Activity, Cry, Consolability)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. Preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. However, the clinical efficacy of preemptive analgesia is still controversial. In this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.

Registry
clinicaltrials.gov
Start Date
July 7, 2016
End Date
July 15, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities
  • ASA class I and II

Exclusion Criteria

  • Coagulopathy
  • Neurological disease
  • Allergy to local anesthetics or contraindication to use of ropivacaine
  • Infection at the site of epidural catheter insertion

Outcomes

Primary Outcomes

FLACC scale score (Face, Legs, Activity, Cry, Consolability)

Time Frame: 0-6 hours after the operation

Study Sites (1)

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