Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 主要终点
- visual analogue scale
研究概览
简要总结
Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
详细描述
Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. Visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end
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
- 是
入选标准
- •delivering for first time(nulliparous)
- •well established labor ( 3 or more contractions in a span of ten minutes
- •cervical dilation of 4 cm or more
- •>= 80% effacement of cervix
排除标准
- •any medical disorder- diabetes,hypertension
- •obstetric high risk factors
研究组 & 干预措施
tramadol
50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
干预措施: Tramadol Hydrochloride (Drug)
distilled water
2ml distilled water intramuscularly will be used as a placebo.
干预措施: Distilled Water (Drug)
结局指标
主要结局
visual analogue scale
时间窗: at 2nd hour of administration
visual analogue scale i.e scaling of severity of pain from 1 being mildest and 10 being most severe will be assessed at 2nd hour of administration
次要结局
- fetal distress(during labor)
- neonatal safety in terms of apgar score and nicu admission(apgar score at 0 and 5 min)
- duration of 1st and 2nd stage of labor(1st and 2nd stage)
- patient satisfaction(at the end of labor( within 12 hours))
- women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness(till the end of labor)
- need for caesarean section or instrumental delivery(during labor)
研究者
dr aastha raheja
post graduate 1st year student obstetrics and gynecology department
Maulana Azad Medical College