Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
- Registration Number
- NCT01598259
- Lead Sponsor
- Shriners Hospitals for Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description melatonin Melatonin Subjects will receive melatonin placebo placebo -
- Primary Outcome Measures
Name Time Method sleep 3 years Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shriners Hospital for Children
🇺🇸Cincinnati, Ohio, United States