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

Concussion, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05065528
• Other study ID #: EGME#01-2021
• Status: Withdrawn
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Spectrum Health - Lakeland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Mild

Intervention

Dietary Supplement:
• 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

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

Locations

Country	Name	City	State
United States	Spectrum Health Lakeland	Saint Joseph	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	return to baseline	proportion of patients in each group who have experienced symptom resolution	48, 72 hours