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

Shriners Hospitals for Children

Status and phase: Completed; Phase 2

Conditions: Burns; Sleep

Treatments: Drug: ramelteon; Drug: zolipidem

Study type: Interventional

Funder types: Other

Identifiers

NCT00539110

09-04-07-01

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

10 participants in 2 patient groups

zolpidem

Experimental group

Description:

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

Treatment:

Drug: zolipidem

ramelteon

Active Comparator group

Description:

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

Treatment:

Drug: ramelteon