Cardiovascular Effects of Racemic Epinephrine Pellets

• Status: Completed
• Trial end date: 2019-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Treatments: Epinephrine

Criteria

Inclusion Criteria:

1. Children ages 2-9 years undergoing general anesthesia for comprehensive dental treatment at the University of Washington Center of Pediatric Dentistry.

2. Healthy patients according to the American Society of Anesthesiologists (ASA) classification I or II.

3. Patients who have caries lesions requiring prefabricated crowns on primary maxillary first molars #B and #I.

Exclusion Criteria:

1. Pediatric patients with any severe systemic illness (ASA Classification III or greater).

2. Pediatric patients with known cardiac arrhythmia, cardiovascular disease, diabetes and thyroid disease.

3. Patients who are taking anti-arrhythmic, antihypertensive, or ionotropic medications.

4. Patients who would need pulpotomy or pulpectomy treatment on primary maxillary first molars #B and I.