Differential Effects of Eszopiclone Versus Ramelteon in Burned Children - Full Text View

Differential Effects of Eszopiclone Versus Ramelteon in Burned Children

This study is not yet open for participant recruitment.
Verified by Shriners Hospitals for Children, October 2007

Sponsored by:	Shriners Hospitals for Children
Information provided by:	Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00539110

Purpose

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

Condition	Intervention
Sleep Burns	Drug: eszopiclone Drug: ramelteon

MedlinePlus related topics:

Burns

Drug Information available for:

Ramelteon Eszopiclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:

polysomnography data [ Time Frame: 2 weeks postburn ]

Secondary Outcome Measures:

hormone levels [ Time Frame: 2 weeks postburn ]

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539110

Contacts


Contact: Michele M Gottschlich, PhD, RD, CNSD	513-872-6298	mgottschlich@shrinenet.org

Contact: Theresa Mayes, BS, RD	513-872-6043	tmayes@shrinenet.org

Locations


United States, Ohio
	Shriners Hospital for Children
	Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

Shriners Hospitals for Children

Investigators


Principal Investigator:	Michele M Gottschlich	Shriners Hospital for Children

More Information

Study ID Numbers:	Sleep III
First Received:	October 2, 2007
Last Updated:	October 3, 2007
ClinicalTrials.gov Identifier:	NCT00539110
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on November 20, 2008