Magnesium sulfate for acute non-traumatic headache in the ED: 2 g vs 4 g vs standard paracetamol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial compares two doses of intravenous magnesium sulfate (2 g and 4 g) against paracetamol (1 g) for adults with an acute non-traumatic headache presenting to the emergency department. Eligible participants have a primary headache disorder of less than 72 hours and moderate to severe pain, and have no conditions that would exclude magnesium or paracetamol use. The study aims to determine which treatment provides better pain relief and safety in the ED setting. Outcomes will focus on short-term pain reduction and adverse events to guide optimal dosing for acute headache management.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Fattouma Bourguiba Monastir
  Monastir, Tunisia Recruiting

Study contacts

• Study coordinator: Semir Nouira, Professor
• Email: semir.nouira@rns.tn
• Phone: 73106046

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.