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NCT03938857 · ClinicalTrials.gov registry record · Phase 1
DOSE Trial of Opioid Sparing Effect
A Phase 1 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03938857: Clinical Trial Phase 1 study, sponsored by Duke University.
NCT03938857 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03938857, a Phase 1 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children. This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.
Primary Outcome
Characterize the opioid-sparing effect of dexmedetomidine when co-administered with fentanyl in children receiving mechanical ventilation. Characterization of differences between dosing exposures for the four groups will allow estimation of the opioid-sparing effect of dexmedetomidine.
Interventions
- DRUG Dexmedetomidine
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 1 |
Why NCT03938857 stopped before completion
NCT03938857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT03938857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03938857 about?
NCT03938857 is a clinical study titled "DOSE Trial of Opioid Sparing Effect". Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children. This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fenta...
What is the current status of trial NCT03938857?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-07-18. Estimated completion is 2020-11-06.
What interventions are being tested in trial NCT03938857?
The interventions under investigation include: Dexmedetomidine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT03938857?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03938857's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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