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Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

NCT ID: NCT05065528

Last Updated: 2024-11-29

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-12-31

Brief Summary

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This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.

Detailed Description

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This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone

Conditions

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Concussion, Mild Traumatic Brain Injury, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill

Intervention

Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days

Group Type EXPERIMENTAL

Magnesium

Intervention Type DIETARY_SUPPLEMENT

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days

Interventions

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Magnesium

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 12 to 18 years;
* presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury;
* GCS \> 13 on arrival

Exclusion Criteria

* age \< 12 years or \> 18 years;
* inability to provide informed consent;
* vomiting \> 2 episodes following injury;
* physical or mental disability hindering adequate response to assessment of symptoms;
* hemodynamic instability/medical condition requiring further acute life-saving medical intervention;
* known brain mass, intracranial hemorrhage, skull fracture;
* known contraindications/allergy to magnesium, ondansetron, or acetaminophen
* pregnant patients
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Health - Lakeland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Trigger, DO

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health - Lakeland

Locations

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Spectrum Health Lakeland

Saint Joseph, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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EGME#01-2021

Identifier Type: -

Identifier Source: org_study_id