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

Primary Purpose

Head Pain

Status
Recruiting
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Magnesium sulfate
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Pain focused on measuring intavenous, magnesium sulfate, nontraumatic, acute headaches, placebo

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MonasrtirRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

magnesium group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2022
Last Updated
February 2, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05325580
Brief Title
Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Official Title
Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Pain
Keywords
intavenous, magnesium sulfate, nontraumatic, acute headaches, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
1g paracetamol + 20 min infusion of 150ml of saline serum
Arm Title
magnesium group
Arm Type
Experimental
Arm Description
1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Other Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department
Description
Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium
Time Frame
1day
Secondary Outcome Measure Information:
Title
Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Description
Patients with Non -Traumatic Acute Headaches in the Emergency Department received 1g paracetamol + 20 min infusion of saline serum
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semir Nouira, Professor
Phone
7310600
Ext
216
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Khaoula Bel Haj Ali, MD
Phone
7310600
Ext
216
Email
belhajalikhaoula@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, Professor
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Monasrtir
City
Monastir
ZIP/Postal Code
5060
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, professor
Phone
73106046
Email
semir.nouira@rns.tn

12. IPD Sharing Statement

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

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