Differential Effects of Zolpidem Versus Ramelteon in Burned Children

Sleep Clinical Trial

— Sleep3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539110
• Other study ID #: 09-04-07-01
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2007
• Last updated: September 13, 2014
• Start date: December 2009
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Sleep

Intervention

Drug:
• zolipidem
dosed at 2200 and 0200 per feeding tube
• ramelteon
medication dosed at 2200 and 0200 per feeding tube

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Shriners Hospitals for Children	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography Data	Determine if intervention product elicits more total sleep time	2 weeks postburn	No
Secondary	Pharmacokinetics	evaluate the PK of zolpidem following standard dosing practices	2 weeks postburn	Yes