Acute Concussion and Melatonin

Sponsor
Children's National Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04731974
Collaborator
(none)
80
2
18

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 5 mg
Phase 1

Detailed 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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 careThis 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 care
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Normal/Control

Control Group/Standard Care

Active Comparator: Melatonin

Melatonin Group

Drug: Melatonin 5 mg
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.

Outcome Measures

Primary Outcome Measures

  1. Change in sleep duration between melatonin and placebo post acute pediatric concussion [30 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

  2. Change in sleep quality between melatonin and placebo post acute pediatric concussion [30 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

  3. Change in depressive symptoms between melatonin and placebo post acute pediatric concussion [30 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 Outcome Measures

  1. Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion [30 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

  2. Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion [30 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's National Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jeremy Root, Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine, Children's National Research Institute
ClinicalTrials.gov Identifier:
NCT04731974
Other Study ID Numbers:
  • Pro00015567
First Posted:
Feb 1, 2021
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022