Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT01598259

Run by

Shriners Hospitals for Children

People needed

10

Starts

2014-05-01

Expected to finish

2016-06-01

Last updated by the study team

2016-06-28

Who can join

Age: 5 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of burn injury
• Scheduled for an elective surgical procedure
• 5 - 22 years of age, inclusive

You may not qualify if…

• 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

Where it is running

• Shriners Hospital for Children — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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