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临床试验/NCT05325580
NCT05325580招募中3 期

Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department

University of Monastir1 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
424
试验地点
1
主要终点
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department

研究概览

简要总结

Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

详细描述

Rate of Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent
  • age >18 years
  • Acute non-traumatic acute headaches
  • patients treated in ED
  • Magnesium sulfate and aspirin administered intravenously (IV)

排除标准

  • Current regular use of analgesics, anticonvulsants or antidepressants
  • Renal disorder with a low glomerular filtration rate (<60 ml/min)
  • Neuromuscular disorder
  • Pregnant woman
  • Contrindication
  • Allergy to NSAID
  • Traumatic Headache
  • Chronic headache ( headache occurring at least 15 days per month for at least 3 months)
  • Hemodynamic instability

研究组 & 干预措施

Placebo Group

Placebo Comparator

1g paracetamol + 20 min infusion of 150ml of saline serum

干预措施: Magnesium sulfate (Drug)

magnesium group

Experimental

1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department

时间窗: 1day

Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium

次要结局

  • Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

Pr.Semir Nouira chef of emergency deparment

University of Monastir

研究点 (1)

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