Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Median pain score during the first 48 hours (Verbal rating PAin Scale)
研究概览
简要总结
C-section deliveries are painful and need adequate analgesia. In the same time, mothers need early rehabilitation to take care of the baby.
Hypothesis: Early oral self administration of painkillers could be as effective as usual IV administration by nursing staff.
Purpose of the study: Evaluation of the efficacy of a program of self administration of painkillers postoperatively of C-section delivery.
详细描述
Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •planned caesarian section
排除标准
- •delivery bleeding which requires general anaesthetic and other surgical treatment
- •contraindication of the targetted anaesthetic because of hemostatis dysfunctionments
- •Signed consent form
- •under 18 years old, toxicomania
- •do not french speacking
- •allergia or contraindication to IMPs
- •suffer from chronicle disease
- •do not affiliate to a health protection
- •do not want to cooperate with the medical staff
研究组 & 干预措施
PCOA
The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.
干预措施: Acetaminophen, ketoprofen, morphine (Drug)
Standard/ IV
The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.
干预措施: Acetaminophen, ketoprofen,morphine (Drug)
结局指标
主要结局
Median pain score during the first 48 hours (Verbal rating PAin Scale)
时间窗: After 48 hours
The pain score will be assessed by investigators at different times : H2 (2 hours after the end of the caesarian), H6, H12, H18, H24, H30, H36 and H48.
次要结局
- Onset of the first request of rescue analgesic drug(maximum 48 hours following the caesarian)