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Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

NCT ID: NCT01477892

Last Updated: 2013-09-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infant, Preterm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low dose remifentanil

continuous infusion of remifentanil 0.1mcg/kg/min

Group Type EXPERIMENTAL

low dose remifentanil

Intervention Type DRUG

non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control

high dose remifentanil

continuous infusion of remifentanil 0.25mcg/kg/min

Group Type ACTIVE_COMPARATOR

low dose remifentanil

Intervention Type DRUG

non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control

Interventions

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low dose remifentanil

non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control

Intervention Type DRUG

Other Intervention Names

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high dose remifentanil

Eligibility Criteria

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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
Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

Assist Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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11172_291

Identifier Type: OTHER

Identifier Source: secondary_id

RFTN-01

Identifier Type: -

Identifier Source: org_study_id