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Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Primary Purpose

Infant, Preterm

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
low dose remifentanil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Preterm

Eligibility Criteria

undefined - 12 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infants mechanically ventilated
  • requiring peripherally induced central catheterization
  • with informed consent of their parents

Exclusion Criteria:

  • major congenital anomalies
  • cardiopulmonary instability
  • use of sedative, antiepileptic drugs or anesthetic drugs
  • grade III or IV intraventricular hemorrhage

Sites / Locations

  • Seoul National University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low dose remifentanil

high dose remifentanil

Arm Description

continuous infusion of remifentanil 0.1mcg/kg/min

continuous infusion of remifentanil 0.25mcg/kg/min

Outcomes

Primary Outcome Measures

Premature Infant Pain Profile
P0-P2 units on a scale ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2) PIPP (preterm infant pain profile) min 0 ~ max 21 higher pain scale on higher score

Secondary Outcome Measures

Adverse Reaction
bradycardia, hypotension, apnea, desaturation

Full Information

First Posted
November 10, 2011
Last Updated
September 11, 2013
Sponsor
Seoul National University Hospital
Collaborators
Ajou University School of Medicine, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01477892
Brief Title
Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
Official Title
Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ajou University School of Medicine, Severance Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Preterm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose remifentanil
Arm Type
Experimental
Arm Description
continuous infusion of remifentanil 0.1mcg/kg/min
Arm Title
high dose remifentanil
Arm Type
Active Comparator
Arm Description
continuous infusion of remifentanil 0.25mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
low dose remifentanil
Other Intervention Name(s)
high dose remifentanil
Intervention Description
non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Primary Outcome Measure Information:
Title
Premature Infant Pain Profile
Description
P0-P2 units on a scale ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2) PIPP (preterm infant pain profile) min 0 ~ max 21 higher pain scale on higher score
Time Frame
first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop
Secondary Outcome Measure Information:
Title
Adverse Reaction
Description
bradycardia, hypotension, apnea, desaturation
Time Frame
during and after 10min of remifentanil continous infusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preterm infants mechanically ventilated requiring peripherally induced central catheterization with informed consent of their parents Exclusion Criteria: major congenital anomalies cardiopulmonary instability use of sedative, antiepileptic drugs or anesthetic drugs grade III or IV intraventricular hemorrhage
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

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