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

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shriners Hospitals for Children
• Treatments: Melatonin

Criteria

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