drugset / Trial / NCT04688346

Cardiovascular Effects of Racemic Epinephrine Pellets

NCT04688346 ↗

Phase 2/3 Completed 13 enrolled University of Washington
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2019-06-10
Primary completion
2019-11-30
Completion
2019-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Racemic Epinephrine Unknown 1.1 mg Topical

Indications

No indication recorded.