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

December 9, 2019 updated by: Yonsei University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yong Seon Choi, MD., PhD.
  • Phone Number: 82-2-2228-2412
  • Email: YSCHOI@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • standard, CEI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 hours after surgery
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
12 hours after surgery
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
24 hours after surgery
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
36 hours after surgery
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
48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The time for the first patient controlled rescue epidural bolus after surgery
Time Frame: 48 hours after surgery
48 hours after surgery
Number of patient-controlled rescue epidural bolus for 48 hours postoperatively
Time Frame: 48 hours after surgery
48 hours after surgery
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)
6 hours after surgery
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)
12 hours after surgery
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)
24 hours after surgery
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)
48 hours after surgery
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.
6 hours after surgery
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.
12 hours after surgery
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.
24 hours after surgery
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.
48 hours after surgery
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
48 hours after surgery
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
48 hours after surgery
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)
48 hours after surgery
A dull feeling the patient feels
Time Frame: 6 hours after surgery
A dull feeling the patient feels : yes or no
6 hours after surgery
A dull feeling the patient feels
Time Frame: 12 hours after surgery
A dull feeling the patient feels : yes or no
12 hours after surgery
A dull feeling the patient feels
Time Frame: 24 hours after surgery
A dull feeling the patient feels : yes or no
24 hours after surgery
A dull feeling the patient feels
Time Frame: 48 hours after surgery
A dull feeling the patient feels : yes or no
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2019-0418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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