Concussion, Mild, Concussion, Brain, Pediatric ALL
Conditions
Brief summary
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.
Detailed 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).
Interventions
DRUGMelatonin 3 MG
Participants in the melatonin group will be instructed to take 3-mg liquid melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.
OTHERPlacebo
Participants in the placebo group will be instructed to take liquid placebo pill 1 hour prior to their habitual fall asleep time daily for 30 days.
Sponsors
Children's National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a prospective single blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Group A: melatonin Group B: routine/standard care
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion | 28 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 | 28 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 | 28 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
| Measure | Time frame | Description |
|---|---|---|
| Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion | 28 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 | 28 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 |
Countries
United States
Contacts
Primary ContactJeremy M Root, MD
Backup ContactBobbe Thomas, BA
Outcome results
None listed