Acute Concussion and Melatonin
Study Details
Study Description
Brief Summary
In this study, the investigator plans a randomized trial of melatonin versus standard care post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
To compare the risk of persistent post-concussive symptoms (PPCS) between melatonin and standard care after an acute pediatric concussion.
To determine if melatonin compared to routine care reduces the risk of PPCS for pediatric patients.
This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 12-19 years old with an acute concussion diagnosis will be eligible. All participants will receive standard of care per treating physician and 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 1 5-mg melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.
All participants will be given a standardized diary to track their daily concussion and sleep symptoms for one month. Research assistants will also arrange follow up in the neurology headache clinic within 4 weeks post injury. At the follow-up visit, subjects will complete the Post Concussion Symptom Inventory (PCSI), a neurologic assessment, sleep assessment and pediatric Functional Disability Inventory.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: Normal/Control Control Group/Standard Care |
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Active Comparator: Melatonin Melatonin Group |
Drug: Melatonin 5 mg
Participants in the melatonin group will be instructed to take 1 5-mg melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.
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Outcome Measures
Primary Outcome Measures
- Change in sleep duration between melatonin and placebo post acute pediatric concussion [30 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 [30 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 [30 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
Secondary Outcome Measures
- Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion [30 days post Emergency Department visit]
It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased relative risk of PPCS compared to those managed with placebo
- Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion [30 days post Emergency Department visit]
It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased time to resolution of concussion symptoms compared to those managed with placebo
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient diagnosed with an acute concussion within 72 hours
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Patient greater than 8 and less than 19 years old
Exclusion Criteria:
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Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include attention deficit disorders)
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Cognitive delay
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Glasgow Coma Score < 14
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positive findings on head computed tomography
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Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
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Use of melatonin within the last week
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Children's National Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Pro00015567