Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Mean duration of first, second and third stage of labour
研究概览
简要总结
It is a well established fact that the pain of labour can be excrutiating and ways to shorten the duration of labour has been sought after. this study compares the role of intramuscular tramadol and intravenous paracetamol in shortening the duration of labour
详细描述
Background: The excruciating pain associated with labour as led to different studies aimed at finding pharmacolologic and non pharmacologic ways of shortening the duration of labour. Most agents used are either expensive or associated with fetomaternal adverse effects. This has led to the study of paracetamol and tramadol that have analgesic properties and have shown to have effect on labour duration.
Aim: To compare intravenous paracetamol versus intramuscular tramadol in shortening the duration of labour at Alex Ekwueme Federal University Teaching Hospital and St Patrick's Mile 4 Hospital, Abakaliki, Ebonyi State.
Methodology: It is an open label, non inferiority randomized controlled trial that was conducted on one hundred and eighty-nine parturients in active labour. Group A received 1000mg of intravenous paracetamol while Group B received 100mg of intramuscular tramadol and allocation was in the ratio of 1:1. Labour duration in the active phase was noted. Data were analyzed using SPSS version 25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Spontaneous active phase labour
- •No contraindication to vaginal delivery
排除标准
- •Clinical evidence of cephalopelvic disproportion
- •Malpresentation,
- •Multiple pregnancy,
- •Previously scarred uterus,
- •Preterm labour,
- •Induced labour
- •Antepartum hemorrhage.
- •History of known allergy to tramadol and paracetamol or opioids or
- •History of narcotics dependency.
- •History of renal disease,
- •Fetal distress
- •Intrauterine fetal death.
研究组 & 干预措施
intramuscular tramadol
100mg of tramadol was given intramuscularly in active phase of labour
干预措施: Tramadol hydrochloride (Drug)
paracetamol
1000mg of paracetamol given intravenously in active phase of labour
干预措施: paracetamol (Drug)
结局指标
主要结局
Mean duration of first, second and third stage of labour
时间窗: 12 hours
the mean of the different stages of labour as well as the total duration of labour
次要结局
未报告次要终点
研究者
Assumpta Nnenna Nweke
Principal Investigator
Federal Teaching Hospital Abakaliki