Acute Concussion and Melatonin

Children's National

Status and phase: Enrolling; Phase 2

Conditions: Pediatric ALL; Concussion, Mild; Concussion, Brain

Treatments: Other: Placebo; Drug: Melatonin 3 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04731974

Pro00015567

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 254 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient diagnosed with an acute concussion within 72 hours
• Patient greater than 8 and less than 19 years old

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Liquid Placebo

Treatment:

Other: Placebo

Melatonin

Active Comparator group

Description:

Liquid Melatonin

Treatment:

Drug: Melatonin 3 MG