The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Difference in total amount of ropivacaine injected through epidural analgesia
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
triple (Participant, Care Provider, investigator)
Eligibility Criteria
- Ages
- 4 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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)
Intervention: Programmed intermittent epidural bolus (Device)
CEI (Continuous epidural infusion)
Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device
Intervention: Continuous epidural infusion (Device)
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
Difference in total amount of ropivacaine injected through epidural analgesia
Time Frame: 6 hours after surgery
The difference in the amount of ropivacaine injected into epidural space for 6 hours postoperatively
Difference in total amount of ropivacaine injected through epidural analgesia
Time Frame: 12 hours after surgery
The difference in the amount of ropivacaine injected into epidural space for 12 hours postoperatively
Difference in total amount of ropivacaine injected through epidural analgesia
Time Frame: 24 hours after surgery
The difference in the amount of ropivacaine injected into epidural space for 24 hours postoperatively
Difference in total amount of ropivacaine injected through epidural analgesia
Time Frame: 36 hours after surgery
The difference in the amount of ropivacaine injected into epidural space for 36 hours postoperatively
Secondary Outcomes
- Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.(48 hours after surgery)
- 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)
- 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)
- A dull feeling the patient feels(6 hours after surgery)
- A dull feeling the patient feels(12 hours after surgery)
- A dull feeling the patient feels(24 hours after surgery)