Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
2 other identifiers
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
September 13, 2013
CompletedSeptember 13, 2013
September 1, 2013
4 months
November 10, 2011
April 12, 2013
September 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop
Secondary Outcomes (1)
Adverse Reaction
during and after 10min of remifentanil continous infusion
Study Arms (2)
low dose remifentanil
EXPERIMENTALcontinuous infusion of remifentanil 0.1mcg/kg/min
high dose remifentanil
ACTIVE COMPARATORcontinuous infusion of remifentanil 0.25mcg/kg/min
Interventions
non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Eligibility Criteria
You may qualify if:
- preterm infants mechanically ventilated
- requiring peripherally induced central catheterization
- with informed consent of their parents
You may not qualify if:
- major congenital anomalies
- cardiopulmonary instability
- use of sedative, antiepileptic drugs or anesthetic drugs
- grade III or IV intraventricular hemorrhage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Ajou University School of Medicinecollaborator
- Severance Hospitalcollaborator
Study Sites (1)
Seoul National University Children's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
relatively small numbers of subjects
Results Point of Contact
- Title
- Pf. Han-suk Kim
- Organization
- Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist Professor
Study Record Dates
First Submitted
November 10, 2011
First Posted
November 23, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 13, 2013
Results First Posted
September 13, 2013
Record last verified: 2013-09