Trial Outcomes & Findings for Cardiovascular Effects of Racemic Epinephrine Pellets (NCT NCT04688346)

Results Overview

To determine heart rate change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

13 participants

Primary outcome timeframe

5 minutes

Results posted on

2021-05-13

Participant Flow

13 participants were enrolled. Each served as their own control. Left side primary maxillary molar received Saline, right side received Epinephrine pellets.

Unit of analysis: Primary Maxillary Molar Teeth

Participant milestones

Participant milestones
Measure	Saline First, Then Epinephrine Saline Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet	First Epinephrine, Then Saline Racemic Epinephrine Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet
Overall Study STARTED	6 6	7 7
Overall Study First Intervention	6 6	7 7
Overall Study Second Intervention	6 6	7 7
Overall Study COMPLETED	6 6	7 7
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline First, Then Epinephrine n=6 Participants Saline Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet	First Epinephrine, Then Saline n=7 Participants Racemic Epinephrine Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet	Total n=13 Participants Total of all reporting groups
Age, Continuous	4.9 years STANDARD_DEVIATION 1.5 • n=6 Participants	4.5 years STANDARD_DEVIATION 1.7 • n=7 Participants	4.7 years STANDARD_DEVIATION 1.6 • n=13 Participants
Sex: Female, Male Female	3 Participants n=6 Participants	3 Participants n=7 Participants	6 Participants n=13 Participants
Sex: Female, Male Male	3 Participants n=6 Participants	4 Participants n=7 Participants	7 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 participants n=6 Participants	7 participants n=7 Participants	13 participants n=13 Participants

PRIMARY outcome

Timeframe: 5 minutes

To determine heart rate change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo.

Outcome measures

Outcome measures
Measure	Control n=13 Participants Saline Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet	Intervention n=13 Participants Racemic Epinephrine Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet
Cardiovascular Outcomes	91.5 Beats Per Minute Standard Deviation 18.2	93.4 Beats Per Minute Standard Deviation 15.1

PRIMARY outcome

Timeframe: 5 minutes

To determine blood pressure change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo.

Outcome measures

Outcome measures
Measure	Control n=13 Participants Saline Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet	Intervention n=13 Participants Racemic Epinephrine Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet
Cardiovascular Outcomes	-3.1 mmhg Standard Deviation 5.1	-2.7 mmhg Standard Deviation 3.6

SECONDARY outcome

Timeframe: 5 minutes

To determine time to achieving hemostasis (based upon subjective assessment of surgeon) on patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo.

Outcome measures

Outcome measures
Measure	Control n=13 Participants Saline Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet	Intervention n=13 Participants Racemic Epinephrine Pellet HemeRX epinephrine pellets: Racemic Epinephrine Pellet
Hemostasis Efficacy	4.2 Minutes Standard Deviation 2	2.2 Minutes Standard Deviation 2

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Travis Nelson

University of Washington

Phone: 206-290-2899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place