NCT01519167

Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 28 Weeks – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ultrasound
• CT Scans
• MRIs

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	0.1 - 1.0 mcg/kg/hr IV
DRUG	Midazolam	0.025 - 2 mg/kg IV
DRUG	Fentanyl	0.5 - 3 mcg/kg IV

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-01-26
• Last updated: 2017-03-20
• Results posted: 2015-08-14

Locations

11 sites across 2 countries: United States, Puerto Rico