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

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury, Mild; Concussion, Mild
• Interventions: Dietary Supplement: Magnesium; Drug: Placebo

• Registration Number: NCT05065528
• Lead Sponsor: Spectrum Health - Lakeland

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

Study Timeline

• Study Start: 2021-08-30
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Magnesium	Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days
Control	Placebo	placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
return to baseline	48, 72 hours	proportion of patients in each group who have experienced symptom resolution
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

Trial Locations

Locations (1)

Spectrum Health Lakeland; 🇺🇸 Saint Joseph, Michigan, United States