Acute Concussion and Melatonin
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Concussion, Brain
- Concussion Mild
- Pediatric ALL
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Group A: melatonin Group B: routine/standard careMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 18 years
- Gender
- Both males and females
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 p...
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.
Tracking Information
- NCT #
- NCT04731974
- Collaborators
- Not Provided
- Investigators
- Not Provided