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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 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03938857
The ClinicalTrials.gov registry entry for NCT03938857 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT03938857 reports 0 study locations.
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.
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