Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 5 - 22 |
| Updated: | 6/29/2016 |
| Start Date: | May 2014 |
| End Date: | June 2016 |
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.
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.
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
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