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

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ClinicalTrials.gov Identifier: NCT04010032
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Correctional Osteotomy Device: Programmed intermittent epidural bolus Device: Continuous epidural infusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: triple (Participant, Care Provider, investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia in Pediatric Patients
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Device: 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
Other Name: PIEB

Active Comparator: CEI (Continuous epidural infusion)
Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device
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
Other Name: standard, CEI




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 Outcome Measures :
  1. The time for the first patient controlled rescue epidural bolus after surgery [ Time Frame: 48 hours after surgery ]
  2. Number of patient-controlled rescue epidural bolus for 48 hours postoperatively [ Time Frame: 48 hours after surgery ]
  3. Pain scores for 6 hours after surgery (VAS) [ Time Frame: 6 hours after surgery ]
    VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)

  4. Pain scores for 12 hours after surgery (VAS) [ Time Frame: 12 hours after surgery ]
    VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)

  5. Pain scores for 24 hours after surgery (VAS) [ Time Frame: 24 hours after surgery ]
    VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)

  6. Pain scores for 48 hours after surgery (VAS) [ Time Frame: 48 hours after surgery ]
    VAS(visual analogue scale) :0(no paine)~10(wort possible, unbearable, excruciating apin)

  7. Pain scores for 6 hours after surgery (r-FLACC) [ Time Frame: 6 hours after surgery ]
    r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.

  8. Pain scores for 12 hours after surgery (r-FLACC) [ Time Frame: 12 hours after surgery ]
    r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.

  9. Pain scores for 24 hours after surgery (r-FLACC) [ Time Frame: 24 hours after surgery ]
    r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.

  10. Pain scores for 48 hours after surgery (r-FLACC) [ Time Frame: 48 hours after surgery ]
    r-FLACC scale (revised Face, Legs, Activity, Cry, Consolability scale): summation of each items and total range is 0~10. higher values represent a more severe pain.

  11. Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. [ Time Frame: 48 hours after surgery ]

    -% of patients with given intravenous additional narcotic analgesics

    • number of administrating intravenous additional narcotic analgesics per patient

  12. Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. [ Time Frame: 48 hours after surgery ]

    -% of patients with given intravenous additional narcotic analgesics

    • total additional dose of intravenous narcotic analgesics per patient

  13. Whether to administer additional intravenous narcotic analgesics with total additional intravenous analgesic dose. [ Time Frame: 48 hours after surgery ]

    -% of patients with given intravenous additional narcotic analgesics

    • measurement tool: Electronic Medical Record(including Drug administration history)

  14. A dull feeling the patient feels [ Time Frame: 6 hours after surgery ]
    A dull feeling the patient feels : yes or no

  15. A dull feeling the patient feels [ Time Frame: 12 hours after surgery ]
    A dull feeling the patient feels : yes or no

  16. A dull feeling the patient feels [ Time Frame: 24 hours after surgery ]
    A dull feeling the patient feels : yes or no

  17. A dull feeling the patient feels [ Time Frame: 48 hours after surgery ]
    A dull feeling the patient feels : yes or no



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Ages Eligible for Study:   4 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010032


Contacts
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Contact: Yong Seon Choi, MD., PhD. 82-2-2228-2412 YSCHOI@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 03722
Contact: Yong Seon Choi, MD, Ph.D    82-2-2228-2412    yschoi@yush.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04010032    
Other Study ID Numbers: 4-2019-0418
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No