Burns
Conditions
Brief summary
The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.
Interventions
OTHERplacebo
po, 1 hour before bed
DRUGMelatonin
po 1 hour before bedtime
Sponsors
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* History of burn injury * Scheduled for an elective surgical procedure * 5 - 22 years of age, inclusive
Exclusion criteria
* History of anoxic brain injury * History of head injury within the last year * Pre-existing seizure disorder * Pre-existing neurological disorder * Pre-existing blindness * Known hypersensitivity to melatonin * Anticoagulant use or aspirin therapy * Antihypertensive medication use * Diabetes mellitus or other endocrine disorders * Autoimmune disorders * Schizophrenia * Inability to access internet * Intellectual disability or inability to follow directions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sleep | 3 years | Measure sleep parameters via polysomnography, actigraphy and urinary melatonin |
Countries
United States
Outcome results
None listed