Using magnesium sulfate to treat acute headaches in the emergency department
Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department
PHASE3 · University of Monastir · NCT05325580
This study tests if giving magnesium sulfate through an IV can help people with sudden headaches in the emergency room feel better compared to a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Monastir (other) |
| Locations | 1 site (Monastir) |
| Trial ID | NCT05325580 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intravenous magnesium sulfate compared to a placebo in treating non-traumatic acute headaches in patients visiting the emergency department. The study involves administering magnesium sulfate and aspirin intravenously to eligible participants while monitoring their headache relief. It aims to determine if magnesium sulfate can provide significant pain relief for acute headaches, potentially offering a new treatment option in emergency settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old experiencing acute non-traumatic headaches who are being treated in the emergency department.
Not a fit: Patients with chronic headaches, traumatic headaches, or those with certain medical conditions such as renal disorders or neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide rapid and effective relief for patients suffering from acute headaches in emergency situations.
How similar studies have performed: While the use of magnesium sulfate for various conditions has been explored, this specific application for acute headaches in the emergency department is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consent * age \>18 years * Acute non-traumatic acute headaches * patients treated in ED * Magnesium sulfate and aspirin administered intravenously (IV) Exclusion Criteria: * 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
Where this trial is running
Monastir
- University of Monasrtir — Monastir, Tunisia (RECRUITING)
Study contacts
- Principal investigator: Semir Nouira, Professor — University of Monastir
- Study coordinator: Semir Nouira, Professor
- Email: semir.nouira@rns.tn
- Phone: 7310600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head Pain, intavenous, magnesium sulfate, nontraumatic, acute headaches, placebo