Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- acute pain of dysmenorrhea measured by visual analogue scale
研究概览
简要总结
Patients presented with primary dysmenorrhea composed the study population. One gram paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in ceasing dysmenorrhea in the emergency department
详细描述
Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received painkiller within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients is measured with the visual analogue scale at baseline, 15th and 30th minutes and 1 hour after study drug administration. At the end of the 60 minutes, rescue drug need is also recorded.
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
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
- •Patients over 18 years old
排除标准
- •denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea
- •Renal or liver failure
- •Allergy to the study drugs
- •Receiving pain killer within the last 6 hours.
- •Physical examination findings consistent with peritoneal irritation
- •Pregnancy or patients with lactation
- •Drug or Alcohol Abuse
研究组 & 干预措施
tramadol
Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.
干预措施: tramadol (Drug)
paracetamol
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.
干预措施: paracetamol (Drug)
结局指标
主要结局
acute pain of dysmenorrhea measured by visual analogue scale
时间窗: 15 minutes
Change in visual analogue scale at 15th minutes from baseline
pain of dysmenorrhea measured by visual analogue scale
时间窗: 60 minutes
Change in visual analogue scale at 60th minutes from baseline
次要结局
- adverse effects.(60 minutes)
- Rescue drug need(30 minutes.)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University