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Phase 3
Age: 18Years - 85Years
All Genders
ID05325580

Treatment of Non-Traumatic Acute Headaches in the Emergency Department Using Intravenous Magnesium Sulfate Compared to Placebo

Led by University of Monastir · Updated on 2024-02-28

424

Participants Needed

1

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of intravenous magnesium sulfate compared to a placebo for treating adults with non-traumatic acute headaches in the emergency department. This phase 3 randomized trial aims to assess how effective magnesium sulfate is when added to paracetamol for relieving headache pain. The study is led by the University of Monastir and focuses on patients aged 18 to 85 years presenting with acute headache symptoms not caused by trauma. Participants receive either 1 gram of paracetamol combined with a 20-minute infusion of 2 grams of magnesium sulfate in saline or 1 gram of paracetamol with a 20-minute infusion of saline alone as a placebo. The trial uses triple blinding to ensure unbiased results. The treatment is given intravenously in the emergency department setting. During the study, participants are closely monitored for headache relief over one day following treatment. Researchers will measure the primary outcome of headache response to magnesium sulfate within 24 hours. Secondary outcomes include comparing placebo effects. The study excludes individuals with certain medical conditions or medication use to ensure safety and accuracy. Participation duration includes the treatment and short-term observation period within the emergency setting.

CONDITIONS

Brief Title

Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

Research Team

S

Semir Nouira, Professor

K

Khaoula Bel Haj Ali, MD

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