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OpenTrials
Completed

NCT Number: NCT00539110

Differential Effects of Zolpidem Versus Ramelteon in Burned Children

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

Completed

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Key information

Conditions

Sleep Burns Wounds and Injuries

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolipidem

Drug

zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization

Other names: Ambien

Ramelteon

Drug

ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization

Other names: rozerem

Primary outcomes

  1. Polysomnography Data

    Time frame: 2 weeks postburn

    Determine if intervention product elicits more total sleep time

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 2 weeks postburn

    evaluate the PK of zolpidem following standard dosing practices

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati

Registry information

Official study title

Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings

Acronym: Sleep3

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2007
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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