Conditions: Ultrasound CT Scans MRIs
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 91
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.

Detailed description:
This study was designed to evaluate the safety of a continuous infusion of dexmedetomidine (1 mcg/kg loading dose with 0.6 mcg/kg/hr initial maintenance dose and titrated between 0.2-1.0 mcg/kg/hr) administered to subjects requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures that are expected to take more than 30 minutes.

Arms:
arm 1: None

Interventions: intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Fentanyl
Intervention descriptions: intervention 1: 0.1 - 1.0 mcg/kg/hr IV intervention 2: 0.025 - 2 mg/kg IV intervention 3: 0.5 - 3 mcg/kg IV

Protocol document: