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

University of Monastir

Status and phase: Enrolling; Phase 3

Conditions: Head Pain

Treatments: Drug: Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05325580

Emergency Monastir

Details and patient eligibility

About

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

Full description

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

Enrollment: 424 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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424 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

1g paracetamol + 20 min infusion of 150ml of saline serum

Treatment:

Drug: Magnesium sulfate

magnesium group

Experimental group

Description:

1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline

Treatment:

Drug: Magnesium sulfate