Phase 2
Completed N=10
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Sleep · Burns
Source: ClinicalTrials.gov NCT00539110 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Polysomnography Data — 373; 346 minutes
Summary
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Polysomnography Data |
373; 346 | — |
| SECONDARY Pharmacokinetics |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00539110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.