Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Seoul National University Hospital14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Infant, Preterm

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

Eligibility

Sex: ALLMax age: 12 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop

Secondary Outcomes

Adverse Reaction

bradycardia, hypotension, apnea, desaturation

Time frame: during and after 10min of remifentanil continous infusion

Data from ClinicalTrials.gov

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