Differential Effects of Zolpidem Versus Ramelteon in Burned Children

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shriners Hospitals for Children
• Collaborator: Children's Hospital Medical Center, Cincinnati
• Treatments: Zolpidem

Criteria

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