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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05325580
Enrollment
424
Registered
2022-04-13
Start date
2021-12-01
Completion date
2026-12-30
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Pain

Keywords

intavenous, magnesium sulfate, nontraumatic, acute headaches, placebo

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

Interventions

DRUGMagnesium 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

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department1dayPatients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium

Secondary

MeasureTime frameDescription
Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department1 dayPatients with Non -Traumatic Acute Headaches in the Emergency Department received 1g paracetamol + 20 min infusion of saline serum

Countries

Tunisia

Contacts

Primary ContactSemir Nouira, Professor
semir.nouira@rns.tn7310600
Backup ContactKhaoula Bel Haj Ali, MD
belhajalikhaoula@yahoo.fr7310600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026