Differential Effects of Zolpidem Versus Ramelteon in Burned Children

Phase 2CompletedNCT00539110

Shriners Hospitals for Children10 enrolled

Overview

To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sleep Burns

Interventions

zolipidemDRUG

zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization

ramelteonDRUG

ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Burn injury \> 20% total body surface area * Between 3 and 18 years of age * \< 7 days from acute injury * Written informed consent and HIPPA release signed Exclusion Criteria: * Suspected anoxic brain injury or head injury * Hepatic or endocrine disease * History of alcoholism or substance abuse * Pre-existing neurological or primary psychiatric disorder * Medical history of pre-existing sleep disorder or lactose deficiency * Questionable survival (\<72 hrs) as decided by PI * Receipt of drugs with known effects on sleep within 24 hrs of study entry * No informed consent/HIPPA release

Locations (1)

Shriners Hospital for Children

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Polysomnography Data

Determine if intervention product elicits more total sleep time

Time frame: 2 weeks postburn

Secondary Outcomes

Pharmacokinetics

evaluate the PK of zolpidem following standard dosing practices

Time frame: 2 weeks postburn

Data from ClinicalTrials.gov

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