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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 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04688346
The ClinicalTrials.gov registry entry for NCT04688346 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HemeRX epinephrine pellets is the first listed.
NCT04688346 reports 0 study locations.
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.
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