Status:

COMPLETED

Cardiovascular Effects of Racemic Epinephrine Pellets

Lead Sponsor:

University of Washington

Conditions:

Epinephrine Causing Adverse Effects in Therapeutic Use

Eligibility:

All Genders

2-9 years

Phase:

PHASE2

PHASE3

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 (M...

Detailed Description

Dental caries is the most common chronic disease of childhood. 3-6% of US children experience early childhood caries, a condition that may necessitate restorative dental treatment. Prefabricated crown...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

June 10 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2019

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT04688346

Start Date

June 10 2019

End Date

November 30 2019

Last Update

May 13 2021

Active Locations (1)

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UW Center for Pediatric Dentistry

Seattle, Washington, United States, 98115