The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients

Yonsei University1 site in 1 country60 target enrollmentJanuary 2020

ConditionsCorrectional Osteotomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Correctional Osteotomy
Sponsor: Yonsei University
Enrollment: 60
Locations: 1
Primary Endpoint: Difference in total amount of ropivacaine injected through epidural analgesia
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study was to compare the efficacy of a programmed intermittent bolus injection method compared to conventional continuous infusion in the management of epidural analgesia in pediatric patients correctional osteotomy. As a prospective double blinded randomized controlled trial, the investigators compare the quality of pain control after surgery.

Registry

clinicaltrials.gov

Start Date

January 2020

End Date

June 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pediatric patients with between 4 and 13 years
•Patients scheduled for correctional osteotomy of the lower extremity
•Pediatric patients whose weight of 40kg of less

Exclusion Criteria

•Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
•Patients with symptoms/signs of elevated intracranial pressure with or without a history of elevated intracranial pressure
•If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)

Outcomes

Primary Outcomes

Difference in total amount of ropivacaine injected through epidural analgesia

Time Frame: 48 hours after surgery

The difference in the amount of ropivacaine injected into epidural space for 48 hours postoperatively

Secondary Outcomes

A dull feeling the patient feels(48 hours after surgery)
The time for the first patient controlled rescue epidural bolus after surgery(48 hours after surgery)
Number of patient-controlled rescue epidural bolus for 48 hours postoperatively(48 hours after surgery)
Pain scores for 6 hours after surgery (VAS)(6 hours after surgery)
Pain scores for 48 hours after surgery (VAS)(48 hours after surgery)
Pain scores for 6 hours after surgery (r-FLACC)(6 hours after surgery)
Pain scores for 12 hours after surgery (VAS)(12 hours after surgery)
Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.(48 hours after surgery)
Pain scores for 24 hours after surgery (VAS)(24 hours after surgery)
Pain scores for 12 hours after surgery (r-FLACC)(12 hours after surgery)
Pain scores for 24 hours after surgery (r-FLACC)(24 hours after surgery)
Pain scores for 48 hours after surgery (r-FLACC)(48 hours after surgery)