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

NCT ID: NCT04010032

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Correctional Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
triple (Participant, Care Provider, investigator)

Study Groups

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PIEB (Programmed intermittent epidural bolus)

bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection)

Group Type EXPERIMENTAL

Programmed intermittent epidural bolus

Intervention Type DEVICE

bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device

CEI (Continuous epidural infusion)

Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device

Group Type ACTIVE_COMPARATOR

Continuous epidural infusion

Intervention Type DEVICE

Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device

Interventions

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Programmed intermittent epidural bolus

bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device

Intervention Type DEVICE

Continuous epidural infusion

Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device

Intervention Type DEVICE

Other Intervention Names

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PIEB standard, CEI

Eligibility Criteria

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Inclusion Criteria

* 1\. Pediatric patients with between 4 and 13 years
* 2\. Patients scheduled for correctional osteotomy of the lower extremity
* 3\. Pediatric patients whose weight of 40kg of less

Exclusion Criteria

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

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Yong Seon Choi, MD., PhD.

Role: CONTACT

Phone: 82-2-2228-2412

Email: [email protected]

Facility Contacts

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Yong Seon Choi, MD, Ph.D

Role: primary

Other Identifiers

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4-2019-0418

Identifier Type: -

Identifier Source: org_study_id