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

NCT ID: NCT05325580

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2026-12-30

Brief Summary

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

Detailed Description

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

Conditions

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Head Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo Group

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

Group Type PLACEBO_COMPARATOR

Magnesium sulfate

Intervention Type 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

magnesium group

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

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type 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

Interventions

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Magnesium 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

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

Pr.Semir Nouira chef of emergency deparment

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semir Nouira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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University of Monasrtir

Monastir, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Semir Nouira, Professor

Role: CONTACT

7310600 ext. 216

Khaoula Bel Haj Ali, MD

Role: CONTACT

7310600 ext. 216

Facility Contacts

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Nouira Semir, professor

Role: primary

Other Identifiers

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Emergency Monastir

Identifier Type: -

Identifier Source: org_study_id

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