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Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

NCT01477892 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2013-09-13

Study results available
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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.

Conditions

  • Infant, Preterm

Interventions

DRUG

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

Sponsors & Collaborators

  • Ajou University School of Medicine

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477892 on ClinicalTrials.gov