Can a mineral ease severe headaches faster than standard painkillers?

NCT ID NCT07779486

Recruiting now Symptom relief Sponsor: University of Monastir Source: ClinicalTrials.gov ↗

This trial is taking on new participants right now.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial asks whether an intravenous dose of magnesium sulfate can relieve acute non-traumatic headaches—such as migraines, tension-type, or cluster headaches—more effectively than the standard painkiller paracetamol. Adults arriving at the emergency department with moderate to severe headache will be randomly assigned to receive either low-dose magnesium, high-dose magnesium, or paracetamol. The main goal is to compare pain reduction at 60 minutes and the proportion of people achieving at least 50% pain relief, while also tracking the need for rescue medication and side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Intravenous magnesium sulfate (2 g or 4 g) compared with intravenous paracetamol (1 g)
What this could lead to: If effective, IV magnesium could offer a new, fast-acting option for treating acute headaches in the emergency department, potentially reducing the need for rescue medication.
What could go wrong: This is a single trial, and results may not apply to all headache types. Magnesium may cause side effects like flushing or low blood pressure, and its benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Acute Pain agnosia cluster headache syndrome Emergencies migraine disorder Tension-Type Headache

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE HEADACHE CLUSTER HEADACHE MIGRAINE TENSION-TYPE HEADACHE

Contacts and locations

Locations

University Hospital Fattouma Bourguiba Monastir
RECRUITING

Monastir, 5000, Tunisia

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