Differential Effects of Zolpidem Versus Ramelteon in Burned Children
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Other Indications, Hospital |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 3 - 18 |
| Updated: | 5/27/2013 |
| Start Date: | December 2009 |
| End Date: | December 2013 |
| Contact: | Michele M Gottschlich, PhD, RD, CNSD |
| Email: | mgottschlich@shrinenet.org |
| Phone: | 513-872-6298 |
Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
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
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