Phase 2
Completed N=8
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Burns · Sedation
Source: ClinicalTrials.gov NCT00697788 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Percent Change in Mean Arterial Pressure (MAP) — 26.7; 30.8; 26.5; 24.5 % change
Summary
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Mean Arterial Pressure (MAP) |
26.7; 30.8; 26.5; 24.5; 25.5; 18 | — |
| SECONDARY Presence of Arrhythmias. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Oxygen Saturation |
99.8; 99.5; 99.5; 98.6; 98.6; 98.6 | — |
| SECONDARY Heart Rate |
125.6; 122; 127.5; 125.5; 122.8; 129.7 | — |
Eligibility Criteria
Inclusion Criteria
- pediatric patient
- >25% total body surface area (tbsa) burn and 0.1 mg/kg/hour of morphine (or equivalent)
- midazolam requirement > 0.1 mg/kg/hour
- treatment team determined that patient should be started on dexmedetomidine
Exclusion Criteria
- hemodynamically unstable patients (epinephrine > 1.0 ug/kg/min, levophed > 0.75 ug/kg/min, dopamine > 10 ug/kg/min)
- pregnant patients
- patients with history of heart block
- patients with congenital heart disease
- patients with significant hepatic dysfunction
- patients with urine output < 0.5 ml/kg/hour [averaged] over past 24 hours
Data sourced from ClinicalTrials.gov (NCT00697788). 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.