Phase 3
Completed N=13
Cardiovascular Effects of Racemic Epinephrine Pellets
Epinephrine Causing Adverse Effects in Therapeutic Use
Source: ClinicalTrials.gov NCT04688346 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Cardiovascular Outcomes — 91.5; 93.4 Beats Per Minute
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiovascular Outcomes |
-3.1; -2.7 | — |
| SECONDARY Hemostasis Efficacy |
4.2; 2.2 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04688346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.