CTRI/2018/06/014589已完成1 期
Efficacy and safety of intravenous paracetamol versus intramuscular tramadol hydrochloride as intrapartum analgesic: a randomised controlled study
government1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月2日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Subjective assessment of intrapartum labour pain accordance to visual analouge scale
研究概览
简要总结
The objective of the study is to compare intravenous paracetamol and intramuscular tramadol as a intrapartum analgesic in terms of reduction of pain according to visual analogue scale ,duration of labour and mode of delivery, maternal side effects intrapartum and postpartum period, fetal APGAR score at 1 min and 5 min number of cases admitted in NICU, fetal hyperbilirubinimia, and any other specific neonatal adverse effects. We expect our study to prove intravenous paracetamol is more effective intrapartum labour analgesic with fewer maternal and fetal side effects as compared to intramuscular tramadol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravidae in spontaneous labour
- •Active phase of labour (cervical dilation of ≥4cm,in the presence of adequate uterine 3 contractions per 10 minutes and each lasting at least for 40 seconds)
- •Maternal age between 18 to 35 years
- •Singleton term pregnancy(
- •42 weeks of gestation)
- •vertex- presenting fetus.
排除标准
- •clinical evidence of cephalopelvic disproportion
- •Malpresentation
- •scrred uterus , previous cesarean section, hysterotomy or myomectomy 4.medical disorders associated with pregnancy, especially severe anemia, jaundice, hypertension,diabetes, renal impairment
- •Fetal distress
- •Receiving any regional or parenteral analgesia before recuitment in the study.
- •Known hypersensitoivity to the drug family
- •induced labour.
结局指标
主要结局
Subjective assessment of intrapartum labour pain accordance to visual analouge scale
时间窗: one year
次要结局
- 1. duration of labour(2. mode of delivery)
研究者
研究点 (1)
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