At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 14 enrolled
Drug / intervention
low dose remifentanildrug
Likely dose
low dose remifentanil 0.1mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant
In Brief
A Phase 2 clinical trial evaluating low dose remifentanil for Infant, Preterm. Completed, enrolled 14 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Preterm
CountriesSouth Korea
CollaboratorsAjou University School of Medicine, Severance Hospital
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartDec 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedNov 23, 2011
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.6 years ago
Interventions
low dose remifentanildrug
non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control