EUCTR2005-003516-29-DE
进行中（未招募）
不适用
Prospective, randomized, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants - RAPIP-Pilotstudie
niversität zu Köln0 个研究点2006年10月20日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Meanwhile it is widely accepted, that ventilated newborns and infants should receive analgesia and sedation for ethical and medical reasons. In this context fentanyl belongs to the mosten often used opioids, with the important disadvantage of prolonged depression of respiratory drive after discontinuation of the infusion.In this clinical trial ventilated term newborns and infants (<60 days) receive either remifentanil or fentanyl for analgesia and sedation.
- 发起方
- niversität zu Köln
- 状态
- 进行中（未招募）
- 最后更新
- 12年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Ventilated term newborns and infants \< 60 days.
- •Expected time of artificial ventilation between 12 and 96 hours.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
排除标准
- •Various conditions of neuromuscular impairment e.g. severe peripartal asphyxia, cerebral infarct, congenital muscular diseases or metabolic defects showing distinct neuromuscular symptoms.
- •Drug abuse of the mother (exclusion criterion for newborns).
- •Known hypersensitivity to Ultiva®, Fentanyl\-Janssen® or fentanyle equivalents.
- •Missing informed consent of the parents.
- •Participation in another clinical trial during or within the last 4 weeks before start of this trial.
结局指标
主要结局
未指定
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