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NCT Number: NCT05325580

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

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Key information

Conditions

Head Pain Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Monasrtir

Monastir, 5060, Tunisia

Location status: Recruiting

Location contact

Nouira Semir, professor

CONTACT

[email protected]

73106046

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

Other names: placebo

Primary outcomes

  1. Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department

    Time frame: 1day

    Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium

Secondary outcomes

  1. Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department

    Time frame: 1 day

    Patients with Non -Traumatic Acute Headaches in the Emergency Department received 1g paracetamol + 20 min infusion of saline serum

Study contacts

Contact information is provided by the study sponsor or research team.

Khaoula Bel Haj Ali, MD

CONTACT

[email protected]

7310600 ext. 216

Semir Nouira, Professor

CONTACT

[email protected]

7310600 ext. 216

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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