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

Spectrum Health - Lakeland

Status

Withdrawn

Conditions

Traumatic Brain Injury, Mild

Concussion, Mild

Treatments

Dietary Supplement: Magnesium

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05065528

EGME#01-2021

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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