Differential Effects of Zolpidem Versus Ramelteon in Burned Children (Sleep3)

This study has been completed.
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
First received: October 2, 2007
Last updated: September 13, 2014
Last verified: September 2014
To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Condition Intervention Phase
Drug: zolipidem
Drug: ramelteon
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings

Resource links provided by NLM:

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Polysomnography Data [ Time Frame: 2 weeks postburn ] [ Designated as safety issue: No ]
    Determine if intervention product elicits more total sleep time

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 weeks postburn ] [ Designated as safety issue: Yes ]
    evaluate the PK of zolpidem following standard dosing practices

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: November 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zolpidem
medication dosed at 2200 and 0200 per feeding tube
Drug: zolipidem
dosed at 2200 and 0200 per feeding tube
Active Comparator: ramelteon
dosed at 2200 and 0200 per the feeding tube
Drug: ramelteon
medication dosed at 2200 and 0200 per feeding tube


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

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

United States, Ohio
Shriners Hospital for Children
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Shriners Hospitals for Children
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Michele M Gottschlich Shriners Hospital for Children
  More Information

Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00539110     History of Changes
Other Study ID Numbers: 09-04-07-01 
Study First Received: October 2, 2007
Results First Received: May 25, 2014
Last Updated: September 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016