Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation (Sleep6)

Shriners Hospitals for Children

Status and phase: Terminated; Phase 2

Conditions: Burns

Treatments: Other: placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01598259

2012-1613

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 5 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

melatonin

Experimental group

Description:

Subjects will receive melatonin

Treatment:

Drug: Melatonin

placebo

Placebo Comparator group

Treatment:

Other: placebo