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

Head Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325580
• Other study ID #: Emergency Monastir
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2023
• Source: University of Monastir
• Contact: Semir Nouira, Professor
• Phone: 7310600
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: December 30, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Head Pain
• Headache

Intervention

Drug:
• Magnesium sulfate
magnesium group 1g paracetamol + 20 min infusion of 2 g magnesium in 150 ml of saline serum and Placebo Group 1g paracetamol + 20 min infusion of 150 ml of saline serum

Locations

Country	Name	City	State
Tunisia	University of Monasrtir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department	Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium	1day
Secondary	Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department	Patients with Non -Traumatic Acute Headaches in the Emergency Department received 1g paracetamol + 20 min infusion of saline serum	1 day