Cardiovascular Effects of Racemic Epinephrine Pellets

NCT04688346 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00006670
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epinephrine Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (2)

• Cardiovascular Outcomes

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

  5 minutes

• Cardiovascular Outcomes

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

  5 minutes

Secondary Outcomes (1)

• Hemostasis Efficacy

  5 minutes

Study Arms (2)

Control

PLACEBO COMPARATOR

Saline Pellet

Drug: HemeRX epinephrine pellets

Intervention

EXPERIMENTAL

Racemic Epinephrine Pellet

Drug: HemeRX epinephrine pellets

Interventions

HemeRX epinephrine pellets DRUG

Racemic Epinephrine Pellet

Control; Intervention

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 2-9 years undergoing general anesthesia for comprehensive dental treatment at the University of Washington Center of Pediatric Dentistry.
• Healthy patients according to the American Society of Anesthesiologists (ASA) classification I or II.
• Patients who have caries lesions requiring prefabricated crowns on primary maxillary first molars #B and #I.

You may not qualify if:

• Pediatric patients with any severe systemic illness (ASA Classification III or greater).
• Pediatric patients with known cardiac arrhythmia, cardiovascular disease, diabetes and thyroid disease.
• Patients who are taking anti-arrhythmic, antihypertensive, or ionotropic medications.
• Patients who would need pulpotomy or pulpectomy treatment on primary maxillary first molars #B and I.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

UW Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

Location

Results Point of Contact

• Title: Dr. Travis Nelson
• Organization: University of Washington

tmnelson@uw.edu

206-290-2899

Study Officials

• Travis M Nelson, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, School of Dentistry

Model Details: This is a, single-blinded, placebo-controlled, split-mouth randomized trial. A sample size of 20 pediatric patients will be used for this pilot study.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: December 30, 2020
• Study Start: June 10, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-05

Locations

US (1)