Differential Effects of Zolpidem Versus Ramelteon in Burned Children

Phase 2

Completed

• Conditions: Burns; Sleep
• Interventions: Drug: zolipidem; Drug: ramelteon

• Registration Number: NCT00539110
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Study Start: 2009-12
• Primary Completion: 2012-12
• Study Completion: 2013-11
• Results First Submitted: 2014-05-25
• Results First Submitted QC: 2014-09-13
• Results First Posted: 2014-09-18
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
zolpidem	zolipidem	zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
ramelteon	ramelteon	ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization

Primary Outcome Measures

Name	Time	Method
Polysomnography Data	2 weeks postburn	Determine if intervention product elicits more total sleep time

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	2 weeks postburn	evaluate the PK of zolpidem following standard dosing practices

Trial Locations

Locations (1)

Shriners Hospital for Children; 🇺🇸 Cincinnati, Ohio, United States