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

Study Overview
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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

Official Title
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A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents

Conditions
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Concussion, Mild, Traumatic Brain Injury, Mild

Intervention / Treatment
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* Dietary Supplement: Magnesium
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days | Drug: Placebo<br>* Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill<br>|
| Experimental: Intervention<br>Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days | Dietary Supplement: Magnesium<br>* Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Concussion Symptom Severity Score | The Post-Concussion Symptom Severity Score is a validated score measuring concussion symptoms and intensity. It measures 22 symptoms on a scale from 0 to 6. The score therefore ranges from 0 (no symptoms) through 132 (maximal symptoms). These will be evaluated at baseline as well as 48 and 72 hours from treatment. Means for each group will be calculated and compared | 48, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effect related to medication administration | proportion of patients in each group who have developed of adverse effects related to medication administration | 48, 72 hours | 
| return to baseline | proportion of patients in each group who have experienced symptom resolution | 48, 72 hours |