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

Yonsei University

Status: Unknown

Conditions: Correctional Osteotomy

Treatments: Device: Programmed intermittent epidural bolus; Device: Continuous epidural infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04010032

4-2019-0418

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

PIEB (Programmed intermittent epidural bolus)

Experimental group

Description:

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

Treatment:

Device: Programmed intermittent epidural bolus

CEI (Continuous epidural infusion)

Active Comparator group

Description:

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

Treatment:

Device: Continuous epidural infusion