Acute Concussion and Melatonin

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's National Research Institute
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Patient diagnosed with an acute concussion within 72 hours

• Patient greater than 8 and less than 19 years old

Exclusion Criteria:

• Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include attention deficit disorders)

• 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