Differential Effects of Zolpidem Versus Ramelteon in Burned Children

Completed · Phase 2

Conditions studied: Sleep, Burns

In brief

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

Key facts

Study ID

NCT00539110

Run by

Shriners Hospitals for Children

People needed

10

Starts

2009-12-01

Expected to finish

2013-11-01

Last updated by the study team

2016-07-27

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shriners Hospital for Children — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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