At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 91 enrolled
Drug / intervention
Dexmedetomidine +2 moredrug
Likely dose
Dexmedetomidine 1.0 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
Hospira, now a wholly owned subsidiary of Pfizer·interventional·Posted Jan 26, 2012·Updated Mar 20, 2017
In Brief
A Phase 4 clinical trial evaluating Dexmedetomidine, Midazolam, and 1 other intervention for Ultrasound and 2 related conditions. Completed, enrolled 91 participants across 11 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUltrasound, CT Scans, MRIs
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartOct 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedJan 26, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.4 years ago
Interventions
Dexmedetomidinedrug
0.1 - 1.0 mcg/kg/hr IV
Midazolamdrug
0.025 - 2 mg/kg IV
Fentanyldrug
0.5 - 3 mcg/kg IV