Differential Effects of Eszopiclone Versus Ramelteon in Burned Children
Information source: Shriners Hospitals for Children
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep; Burns
Intervention: eszopiclone (Drug); ramelteon (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Shriners Hospitals for Children Official(s) and/or principal investigator(s):
Michele M Gottschlich, Principal Investigator, Affiliation: Shriners Hospital for Children
Overall contact:
Michele M Gottschlich, PhD, RD, CNSD, Phone: 513-872-6298, Email: mgottschlich@shrinenet.org
Summary
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Clinical Details
Study design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Primary outcome: polysomnography data
Secondary outcome: hormone levels
Eligibility
Minimum age: 3 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Michele M Gottschlich, PhD, RD, CNSD, Phone: 513-872-6298, Email: mgottschlich@shrinenet.org
Shriners Hospital for Children, Cincinnati, Ohio 45229, United States; Not yet recruiting
Michele M Gottschlich, PhD, RD, CNSD, Phone: 513-872-6298, Email: mgottschlich@shrinenet.org
Theresa Mayes, BS, RD, Phone: 513-872-6043, Email: tmayes@shrinenet.org
Additional Information
Last updated: October 3, 2007
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