NCT02571179已完成4 期
Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety
Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fentanyl maximum concentration
研究概览
简要总结
Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate
排除标准
- •a disease that might affect hepatic or renal function, contraindications to opioid analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography, meconium stained amniotic fluid or placental insufficiency. The subjects should not have received fentanyl during the previous 14 days.
- •Not agreed to participate
研究组 & 干预措施
Intranasal fentanyl 50 microg/dose
Experimental
patient was given intranasal fentanyl 50 microg/dose up to 250 microg
干预措施: intranasal fentanyl 50 microg dose up to 250 microg (Drug)
结局指标
主要结局
Fentanyl maximum concentration
时间窗: From the first intranasal fentanyl dose to birth of the newborn up to 48 hours
次要结局
未报告次要终点
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital
研究点 (1)
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