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High- vs Standard-Dose Intravenous Magnesium for Acute Headache

RecruitingNAAges 18 Years - anyAllUniversity of Monastir
NCT07779486 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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: * Migraine * 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 Exclusion Criteria: * 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
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What it tests

  • Magnesium Sulfate 2 grams
  • Magnesium Sulfate 4 G
  • Paracetamol 1 g
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Where

1 site
University Hospital Fattouma Bourguiba Monastir
Monastir, Tunisia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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