Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
February 27, 2024 updated by: Pr. Semir Nouira, University of Monastir
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
Study Overview
Detailed Description
Rate of Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Study Type
Interventional
Enrollment (Estimated)
424
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Khaoula Bel Haj Ali, MD
- Phone Number: 216 7310600
- Email: belhajalikhaoula@yahoo.fr
Study Contact Backup
- Name: Semir Nouira, Professor
- Phone Number: 216 7310600
- Email: semir.nouira@rns.tn
Study Locations
-
-
-
Monastir, Tunisia, 5060
- Recruiting
- University of Monasrtir
-
Contact:
- Nouira Semir, professor
- Phone Number: 73106046
- Email: semir.nouira@rns.tn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Group
1g paracetamol + 20 min infusion of 150ml of saline serum
|
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:
|
|
Experimental: magnesium group
1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Semir Nouira, Professor, University of Monastir
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
April 5, 2022
First Posted (Actual)
April 13, 2022
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease Attributes
- Emergencies
- Headache
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- Emergency Monastir
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.