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

NCT05325580 | Recruiting Phase 3

• 1 other identifier: Emergency Monastir
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head Pain

Keywords

intavenous; magnesium sulfate; nontraumatic; acute headaches; placebo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 day

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Magnesium sulfate

magnesium group

EXPERIMENTAL

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

Drug: Magnesium sulfate

Interventions

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

Also known as: placebo

Placebo Group; magnesium group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• age \>18 years
• Acute non-traumatic acute headaches
• patients treated in ED
• Magnesium sulfate and aspirin administered intravenously (IV)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

University of Monasrtir

Monastir, 5060, Tunisia

RECRUITING

MeSH Terms

Conditions

Headache

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Semir Nouira, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Semir Nouira, Professor

CONTACT

7310600; semir.nouira@rns.tn

Khaoula Bel Haj Ali, MD

CONTACT

7310600; belhajalikhaoula@yahoo.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr.Semir Nouira chef of emergency deparment

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 13, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 28, 2024

Record last verified: 2023-02

Locations

TU (1)