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

Phase 3

Recruiting

• Conditions: Head Pain
• Interventions: Drug: Magnesium sulfate

• Registration Number: NCT05325580
• Lead Sponsor: University of Monastir

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Status Verified: 2023-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 424

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Magnesium sulfate	1g paracetamol + 20 min infusion of 150ml of saline serum
magnesium group	Magnesium sulfate	1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline

Primary Outcome Measures

Name	Time	Method
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department	1day	Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium

Secondary Outcome Measures

Name	Time	Method
Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department	1 day	Patients with Non -Traumatic Acute Headaches in the Emergency Department received 1g paracetamol + 20 min infusion of saline serum

Trial Locations

Locations (1)

University of Monasrtir; 🇹🇳 Monastir, Tunisia