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NCT01519167 · ClinicalTrials.gov registry record · Phase 4
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
A Phase 4 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
NCT01519167: Completed Phase 4 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
NCT01519167 is a Phase 4 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 91 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519167, a Phase 4 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
Study 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.
Primary Outcome
Success in sedation was defined by a combined endpoint which was the combination of the following: 1. Subject had adequate level of sedation (University of Michigan Sedation Scale \[UMSS\] score between 1 to 3 \[minimally sedated to deeply sedated\] or Neonatal Pain, Agitation and Sedation Scale \[N-PASS\] score between -5 to -2 \[Light sedation\]) at least 80% of the time the subject was given the study drug. 2. Subject had successfully completed the procedure without a need for rescue sedatio
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
What the finished NCT01519167 record still lists
NCT01519167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01519167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519167 about?
NCT01519167 is a clinical study titled "Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation". 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.
What is the current status of trial NCT01519167?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2012-10. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01519167?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT01519167?
This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01519167's enrollment target sits among peer trials
91 884th of 2000 higher than 1,115 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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