Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05065528
Status:
WITHDRAWN
Last Update Posted:
2022-08-15
First Post:
2021-09-23
Brief Title:
Mag Con Efficacy of Oral Mag in Acute Concussion in Adolescents
Sponsor:
Spectrum Health - Lakeland
Organization:
Spectrum Health - Lakeland
Study Overview
Official Title:
A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not recruit any participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None