Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Phase 1

Completed

• Conditions: Infant, Preterm
• Interventions: Drug: low dose remifentanil

• Registration Number: NCT01477892
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Study Start: 2011-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-04-12
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-11
• Last Update Submitted: 2013-09-11
• Results First Posted: 2013-09-13
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose remifentanil	low dose remifentanil	continuous infusion of remifentanil 0.25mcg/kg/min
low dose remifentanil	low dose remifentanil	continuous infusion of remifentanil 0.1mcg/kg/min

Primary Outcome Measures

Name	Time	Method
Premature Infant Pain Profile	first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop	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

Name	Time	Method
Adverse Reaction	during and after 10min of remifentanil continous infusion	bradycardia, hypotension, apnea, desaturation

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of