Clinical trial NCT04010032: The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
Official title: The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Correctional Osteotomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Difference in total amount of ropivacaine injected through epidural analgesia
timeFrame: 6 hours after surgery
measure: Difference in total amount of ropivacaine injected through epidural analgesia
timeFrame: 12 hours after surgery
measure: Difference in total amount of ropivacaine injected through epidural analgesia
timeFrame: 24 hours after surgery
measure: Difference in total amount of ropivacaine injected through epidural analgesia
timeFrame: 36 hours after surgery
measure: Difference in total amount of ropivacaine injected through epidural analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: The time for the first patient controlled rescue epidural bolus after surgery
timeFrame: 48 hours after surgery
measure: Number of patient-controlled rescue epidural bolus for 48 hours postoperatively
timeFrame: 48 hours after surgery
measure: Pain scores for 6 hours after surgery (VAS)
timeFrame: 6 hours after surgery
measure: Pain scores for 12 hours after surgery (VAS)
timeFrame: 12 hours after surgery
measure: Pain scores for 24 hours after surgery (VAS)
timeFrame: 24 hours after surgery
measure: Pain scores for 48 hours after surgery (VAS)
timeFrame: 48 hours after surgery
measure: Pain scores for 6 hours after surgery (r-FLACC)
timeFrame: 6 hours after surgery
measure: Pain scores for 12 hours after surgery (r-FLACC)
timeFrame: 12 hours after surgery
measure: Pain scores for 24 hours after surgery (r-FLACC)
timeFrame: 24 hours after surgery
measure: Pain scores for 48 hours after surgery (r-FLACC)
timeFrame: 48 hours after surgery
measure: Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
timeFrame: 48 hours after surgery
measure: Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
timeFrame: 48 hours after surgery
measure: Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose.
timeFrame: 48 hours after surgery
measure: A dull feeling the patient feels
timeFrame: 6 hours after surgery
measure: A dull feeling the patient feels
timeFrame: 12 hours after surgery
measure: A dull feeling the patient feels
timeFrame: 24 hours after surgery
measure: A dull feeling the patient feels
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References: