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

Phase 2TerminatedNCT01598259

Shriners Hospitals for Children10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Burns

Interventions

MelatoninDRUG

po 1 hour before bedtime

placeboOTHER

po, 1 hour before bed

Eligibility

Sex: ALLMin age: 5 YearsMax age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Shriners Hospital for Children

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

sleep

Measure sleep parameters via polysomnography, actigraphy and urinary melatonin

Time frame: 3 years

Data from ClinicalTrials.gov

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