The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The efficacy and safety of oxycodone in labor pain
研究概览
简要总结
Childbirth is one of the most painful events that a woman is likely to experience, and thus is a major concern for most parturient. Severe pain releases stress mediators and may thus compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the golden standard for the management of severe labor pain. However, it could not always be used both due the parturient related factors and the organizational reasons.However, the knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is limited.
Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth.
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
- •Labouring healthy women
- •Early labour
- •Age 18-45 years
排除标准
- •Sleep apnea or other central deficit affecting breathing
- •Pulmonary insufficiency
- •Liver of kidney insufficiency
- •Use of mono amine oxidase medication
- •Thyroid, pituitary insufficiency
- •Paralytic ileus
- •Other contraindication specified by the investigator
研究组 & 干预措施
Oxycodone, labour pain
干预措施: Oxycodone (Drug)
结局指标
主要结局
The efficacy and safety of oxycodone in labor pain
时间窗: 24 hours
次要结局
- The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth(24 hours)