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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00539110
First received: October 2, 2007
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Sleep
Burns
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 deeper sleep (stages 3/4 and REM)


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

  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

Locations
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
Investigators
Principal Investigator: Michele M Gottschlich Shriners Hospital for Children
  More Information

No publications provided

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
Last Updated: November 29, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014