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NCT04688346 · ClinicalTrials.gov registry record · Phase 2
Cardiovascular Effects of Racemic Epinephrine Pellets
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04688346: Completed Phase 2 study, sponsored by University of Washington.
NCT04688346 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04688346, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary aim of this study was to determine if topical racemic epinephrine pellets affect heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) or mean arterial pressure (MAP) in children receiving dental care under general anesthesia (GA). Thirteen patients requiring prefabricated zirconia crowns on both primary maxillary first molars were recruited into a split-mouth randomized controlled pilot study. Patients received a continuous infusion of propofol and remifentanil with inhaled nitrous oxide/oxygen. After patient randomization and tooth preparation, either saline pellets (control) or racemic epinephrine pellets (treatment) were applied directly to gingival tissue. Vital sign measurements were recorded for 5 minutes. The procedure was repeated with either control or treatment on the contralateral side.
Primary Outcome
To determine heart rate change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo.
Interventions
- DRUG HemeRX epinephrine pellets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2019-11-30 |
| Phase | Phase 2 |
What the finished NCT04688346 record still lists
NCT04688346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which HemeRX epinephrine pellets is the first listed.
NCT04688346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04688346 about?
NCT04688346 is a clinical study titled "Cardiovascular Effects of Racemic Epinephrine Pellets". The primary aim of this study was to determine if topical racemic epinephrine pellets affect heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) or mean arterial pressure (MAP) in children receiving dental care under general anesthesia (GA). Thirteen patients requiring pre...
What is the current status of trial NCT04688346?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-06-10. Estimated completion is 2019-11-30.
What interventions are being tested in trial NCT04688346?
The interventions under investigation include: HemeRX epinephrine pellets (DRUG).
Who is sponsoring clinical trial NCT04688346?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04688346's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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