Burns, Sleep
Conditions
Brief summary
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Interventions
DRUGzolipidem
zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
DRUGramelteon
ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Sponsors
Children's Hospital Medical Center, Cincinnati
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography Data | 2 weeks postburn | Determine if intervention product elicits more total sleep time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 2 weeks postburn | evaluate the PK of zolpidem following standard dosing practices |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zolpidem First, Then Ramelteon dosed at 2200 and 0200 per the feeding tube | 5 |
| Ramelteon First, Then Zolpidem dosed at 2200 and 0200 per the feeding tube | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Zolpidem First, Then Ramelteon | Ramelteon First, Then Zolpidem | Total |
|---|---|---|---|
| Age, Continuous | 7.8 years STANDARD_DEVIATION 1.6 | 7.8 years STANDARD_DEVIATION 1.6 | 7.8 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Polysomnography Data
Determine if intervention product elicits more total sleep time
Time frame: 2 weeks postburn
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zolpidem | Polysomnography Data | 373 minutes | Standard Error 40 |
| Ramelteon | Polysomnography Data | 346 minutes | Standard Error 33 |
Secondary
Pharmacokinetics
evaluate the PK of zolpidem following standard dosing practices
Time frame: 2 weeks postburn