Paracetamol versus tramadol intravenous infusion for labor analgesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Visual analogue score assessment of labor analgesia
研究概览
简要总结
This study is a prospective,randomized comparative study.It will compare the effect of paracetamol intravenous infusion with tramadol intravenous infusion in providing labor analgesia and maternal and fetal side effects.
Intravenous infusion of study drug will be started after assessing baseline Visual analogue score in active phase of labor in singelton pregnancy according to randomly divided two groups.
Paracetamol infusion in few studies done have shown to be safe and more efficacious than intravenous tramadol infusion for labor analgesia.It has no side effects of opioids like nausea, vomiting or sedation in the parturient and also safe for neonates.Paracetamol is also easily available, , affordable and easy to administer as tramadol.So, in this study we will compare the effect of 1g paracetamol and 1mg/Kg tramadol intravenous infusion in providing labor analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients for intented vaginal delivery in active phase of labor with cervical dilatation from 4-6cm 2.Gestational age (37-41 weeks) 3.Spontaneous or induced Labor 4.Age (18-35 years)
- •Primigravida / Multigravida(upto parity 1) 6.Singlenton pregnancy with viable fetus 7.Vertex presentation 8.Patients not a candidate for neuraxial analgesia for various reasons(not willing/presence of contraindications,etc.) 9.Non scarred uterus.
排除标准
- •1.Medical disorder.
- •Pregestational Diabetes Mellitus, Rheumatic heart disease, chronic hypertension,Severe anaemia, Liver disease , Renal disease and Epilepsy 2.Preclampsia ,Eclampsia 3.Gestational diabetes mellitus on insulin therapy. 4.Use of any other kind of analgesia before recruitment in study. 5.Non reassuring fetal heart rate 6.Antepartum haemorrhage 7.Polyhydramnios,Intrauterine growth restriction 8.Chorioamnionitis 9.Hypersenstivity to paracetamol.
结局指标
主要结局
Visual analogue score assessment of labor analgesia
时间窗: At start of giving drug, at 1 hour and 3 hours of drug adminstration
次要结局
- Duration of active phase of first stage of labor, duration of second stage of labor, fetal bradycardia, mode of delivery,respiratory depression in baby, neonatal apgar score,NICU admissions(From start of giving drug till the time of discharge from hospital)