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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days |
|
| Intervention | Experimental | Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium | Dietary Supplement | Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| return to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Trigger, DO | Corewell Health South | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Lakeland | Saint Joseph | Michigan | 49085 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Placebo | Drug | Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill |
|
proportion of patients in each group who have experienced symptom resolution
| 48, 72 hours |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D008670 |
| Metals |