Concussion, Mild, Traumatic Brain Injury, Mild
Conditions
Brief summary
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
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
Interventions
DIETARY_SUPPLEMENTMagnesium
Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days
DRUGPlacebo
Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill
Sponsors
Corewell Health South
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Concussion Symptom Severity Score | 48, 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effect related to medication administration | 48, 72 hours | proportion of patients in each group who have developed of adverse effects related to medication administration |
| return to baseline | 48, 72 hours | proportion of patients in each group who have experienced symptom resolution |
Countries
United States
Outcome results
None listed