Recruitment

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