A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Post-Concussion Symptom Severity Score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days
干预措施: Placebo (Drug)
Intervention
Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days
干预措施: Magnesium (Dietary Supplement)
结局指标
主要结局
Post-Concussion Symptom Severity Score
时间窗: 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
次要结局
- return to baseline(48, 72 hours)
- adverse effect related to medication administration(48, 72 hours)