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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014