Intravenous Magnesium Sulfate Versus Paracetamol for the Treatment of Acute Non-Traumatic Headache in the Emergency Department: A Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity at 60 Minutes
研究概览
简要总结
Headache is one of the most common reasons for consultation in emergency departments and represents a significant cause of disability, particularly in patients with migraine and other primary headache disorders. Despite the availability of several analgesic treatments, including nonsteroidal anti-inflammatory drugs and paracetamol, pain relief is often incomplete, and a proportion of patients require additional rescue therapy.
Magnesium sulfate has emerged as a potential therapeutic option in acute headache due to its role in modulating neuronal excitability, vascular tone, and pain-related neurotransmitter release. However, its efficacy as a standalone treatment, the optimal intravenous dose, and its comparative effectiveness versus standard therapy remain unclear.
This randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of intravenous magnesium sulfate in the treatment of acute non-traumatic headache in the emergency department. Participants will be randomly assigned to receive either low-dose magnesium sulfate (2 g IV), high-dose magnesium sulfate (4 g IV), or intravenous paracetamol (1 g IV) as an active comparator.
The primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS) at 60 minutes after treatment administration, as well as the proportion of patients achieving at least 50% pain reduction. Secondary outcomes include time course of pain relief, need for rescue medication, adverse events, patient satisfaction, and length of stay in the emergency department.
In addition, the study will assess baseline ionized magnesium levels to explore their relationship with treatment response and evaluate whether magnesium levels may predict clinical efficacy.
The results of this study may help clarify the role of intravenous magnesium sulfate in the management of acute headache and potentially improve treatment strategies in emergency settings.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Presentation to the emergency department with acute non-traumatic headache of less than 72 hours duration
- •Diagnosis consistent with a primary headache disorder, including:
- •Tension-type headache
- •Cluster headache (according to ICHD-3 criteria)
- •Moderate to severe pain intensity (VAS ≥5/10)
- •Ability to understand the study procedures and provide informed consent
排除标准
- •Suspected or confirmed secondary headache (e.g., intracranial hemorrhage, infection, mass lesion)
- •Recent head trauma
- •Known hypersensitivity or contraindication to magnesium sulfate or paracetamol
- •Use of analgesic medication within the previous 6 hours
- •Pregnancy or breastfeeding
- •Severe renal insufficiency or conditions contraindicating magnesium administration
- •Hemodynamic instability or clinically significant cardiac conduction disorders Prior participation in this study
研究组 & 干预措施
Paracetamol 1 g IV
Intravenous paracetamol 1 g diluted in 100 mL, administered over 10-15 minutes.
干预措施: Paracetamol 1 g (Drug)
Magnesium Sulfate 2 g IV
Intravenous magnesium sulfate administered as a single dose of 2 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes.
干预措施: Magnesium Sulfate 2 grams (Drug)
Magnesium Sulfate 4 g IV
Intravenous magnesium sulfate administered as a single dose of 4 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes.
干预措施: Magnesium Sulfate 4 G (Drug)
结局指标
主要结局
Change in Pain Intensity at 60 Minutes
时间窗: 60 minutes
Change in pain intensity measured using the Visual Analog Scale (VAS, 0-10) from baseline to 60 minutes after treatment administration
Proportion of Responders at 60 Minutes
时间窗: 60 minutes
Proportion of participants achieving a ≥50% reduction in VAS pain score from baseline at 60 minutes.
次要结局
- Pain Intensity Over Time(0 to 120 minutes)
- Time to Clinically Meaningful Pain Relief(Up to 120 minutes)
- Use of Rescue Medication(30 to 120 minutes)
- Adverse Events(0 to 120 minutes)
研究者
Pr. Semir Nouira
Professor
University of Monastir