Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain during labour
研究概览
简要总结
Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 37 and 40 6/7 weeks
- •Primiparous patient
- •Singleton
- •4 to 5 cms of dilation
- •Intact membranes or spontaneous rupture of membranes less than 2 hours
- •Fetus in a vertex presentation
- •Gynecoid pelvis by clinical examination
排除标准
- •Multiparous
- •Multiple pregnancies
- •Any pathology
- •Induction of labour with prostaglandins
研究组 & 干预措施
Tramadol
100 mg of tramadol SC (single dose) = 2 mL
干预措施: Tramadol (Drug)
Placebo
2 mL of a sterile solution SC
干预措施: Placebo (Drug)
结局指标
主要结局
Pain during labour
时间窗: 6 hours
Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).
次要结局
- Duration of labour(12 hours)
- Neonatal outcomes(48 hours)
- Side effects(48 hours)
- Requirements of oxytocin(12 hours)
研究者
Osvaldo A. Reyes T.
Coordinator of Research
Saint Thomas Hospital, Panama