Evaluation of Intravenous Magnesium Administration in the Treatment of Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain intensity measured by Visual Analog Scale (VAS)
研究概览
简要总结
This prospective, randomized, double-blind clinical trial aims to evaluate the analgesic efficacy of intravenous magnesium sulfate in women presenting to the emergency department with acute dysmenorrhea. Participants will be randomized into two groups receiving either 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Pain levels will be assessed using the Visual Analog Scale (VAS) before and after treatment.
详细描述
This prospective, randomized, double-blind clinical trial is designed to evaluate the analgesic effectiveness of intravenous magnesium sulfate in women aged 18 to 35 years presenting to the emergency department with acute dysmenorrhea. Participants will be randomly assigned to one of two treatment groups: 2 ampoules of magnesium sulfate or intravenous dexketoprofen.
All medications will be diluted in 100 ml of normal saline and administered intravenously over 15 minutes. Pain intensity will be assessed using the Visual Analog Scale (VAS) before treatment and 1 hour after administration. Secondary outcomes include patient satisfaction, vital sign changes, and adverse effects.
The study aims to compare the analgesic efficacy and safety profile of intravenous magnesium sulfate with that of a standard nonsteroidal anti-inflammatory drug (dexketoprofen) in the management of acute dysmenorrhea.
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
- None
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
- •Female patients aged 18 to 35 years
- •Presenting to the obstetrics and gynecology emergency department with a diagnosis of primary dysmenorrhea
- •Having regular menstrual cycles within the last 6 months
- •Having a Visual Analog Scale (VAS) pain score of ≥6 at emergency admission
- •Providing written informed consent for participation in the study
排除标准
- •Patients with secondary dysmenorrhea or underlying gynecological pathology
- •Pregnancy or breastfeeding
- •Use of analgesics or muscle relaxants within the last 3 days
- •Known allergy to magnesium sulfate or dexketoprofen trometamol
- •History of renal failure, cardiac arrhythmia, or serious systemic disease
- •Inability to assess pain due to mental disability or communication disorder
- •Failure to provide informed consent for participation in the study
研究组 & 干预措施
Magnesium Sulfate 2 Ampoules
Participants receive 2 ampoules (8 ml total) of intravenous magnesium sulfate diluted in 100 ml normal saline, administered over 15 minutes.
干预措施: Magnesium Sulfate (2 Ampoules) (Drug)
Intravenous Dexketoprofen
Participants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes.
干预措施: Dexketoprofen (Drug)
结局指标
主要结局
Change in pain intensity measured by Visual Analog Scale (VAS)
时间窗: Baseline and 1 hour after intravenous treatment
Pain severity will be assessed using the 0-10 Visual Analog Scale (VAS) before treatment and 1 hour post-treatment. The study will evaluate and compare the analgesic effect of two different doses of intravenous magnesium sulfate (2 ampoules vs. 3 ampoules) and compare both to intravenous dexketoprofen in women presenting with acute dysmenorrhea.
次要结局
未报告次要终点
研究者
Havva Betül Bacak
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Gaziosmanpasa Research and Education Hospital