Evaluation of Safety and Efficacy of Remifentanil in Preterm Infant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Premature Infant Pain Profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants mechanically ventilated
- •requiring peripherally induced central catheterization
- •with informed consent of their parents
排除标准
- •major congenital anomalies
- •cardiopulmonary instability
- •use of sedative, antiepileptic drugs or anesthetic drugs
- •grade III or IV intraventricular hemorrhage
研究组 & 干预措施
low dose remifentanil
continuous infusion of remifentanil 0.1mcg/kg/min
干预措施: low dose remifentanil (Drug)
high dose remifentanil
continuous infusion of remifentanil 0.25mcg/kg/min
干预措施: low dose remifentanil (Drug)
结局指标
主要结局
Premature Infant Pain Profile
时间窗: 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
次要结局
- Adverse Reaction(during and after 10min of remifentanil continous infusion)
研究者
Han-Suk Kim
Assist Professor
Seoul National University Hospital