The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
研究概览
简要总结
In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.
详细描述
To compare the risk of persistent post-concussive symptoms (PPCS) between melatonin and placebo after an acute pediatric concussion.
To determine if melatonin compared to placebo reduces the risk of PPCS for pediatric patients.
This is a prospective single-blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 12-18 years old with an acute concussion diagnosis will be eligible. All participants will receive actigraphy watches to wear on their wrists and measure sleep and activity patterns. Participants in the melatonin group will be instructed to take 3 mg of liquid melatonin 1 hour prior to their habitual fall asleep time daily for 30 days. Participants in the placebo group will be instructed to take their placebo liquid 1/2 hour prior to their habitual fall asleep time daily for 30 days.
All participants will be given standardized weekly assessments to track their concussion, sleep and depressive symptoms for one month. Research assistants will also arrange follow up in the telemedicine neurology headache clinic within 4 weeks post injury. At the follow-up visit, subjects will complete the Post Concussion Symptom Inventory (PCSI), Pediatric Sleep Disturbance (PSD), and Revised Childhood Anxiety and Depression Scales (RCADS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Patient diagnosed with an acute concussion within 72 hours
- •Patient greater than 8 and less than 19 years old
排除标准
- •Currently taking psychiatric medication
- •Cognitive delay
- •Glasgow Coma Score < 14
- •positive findings on head computed tomography
- •Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
- •Use of melatonin within the last week
研究组 & 干预措施
Placebo
Liquid Placebo
干预措施: Placebo (Other)
Melatonin
Liquid Melatonin
干预措施: Melatonin 3 MG (Drug)
结局指标
主要结局
Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
时间窗: 28 days post Emergency Department visit
It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep duration compared to placebo
Change in sleep quality between melatonin and placebo post acute pediatric concussion
时间窗: 28 days post Emergency Department visit
It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep quality compared to placebo
Change in depressive symptoms between melatonin and placebo post acute pediatric concussion
时间窗: 28 days post Emergency Department visit
It is hypothesized that subjects managed with melatonin post an acute concussion will have decreased depressive symptoms compared to placebo
次要结局
- Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion(28 days post Emergency Department visit)
- Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion(28 days post Emergency Department visit)
研究者
Jeremy Root
Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine
Children's National Research Institute