Buffered Lidocaine in the Pediatric Dental Patient

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Local anesthetic buffered with sodium bicarbonate has been suggested to reduce pain, discomfort and onset time of local anesthesia on injection into tissue, compared to non-buffered solutions. Buffered local anesthesia has been used in medicine, however intraoral injections with buffered solutions are less common in dentistry. Most research has focused on adult perception of pain on administration of buffered local anesthetic. There have been few studies and inconclusive evidence to show that buffered lidocaine reduces the perception of pain on administration in children. The purpose of this interventional study is to assess pain reduction and onset time on injection of buffered 2% lidocaine with 1:100,000 epinephrine in children.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geisinger Clinic
• Treatments: Epinephrine; Lidocaine

Criteria

Inclusion Criteria:

1. Patients requiring restorative or surgical dental treatment on two occasions on opposite sides of the mouth; either both maxillary or both mandibular quadrant/sextant involving comparable teeth/areas

2. Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis

3. Patients 4-17 years of age

4. Patients classified as ASA I or ASA II

5. Patients of parents who can read, write and give consent in English

Exclusion Criteria:

1. Patients with allergy to local anesthetic

2. Patients who are pregnant or nursing

3. Patients with cardiac concerns or contraindications to epinephrine

4. Patients unable to undergo dental treatment in the clinic for behavior or medical reasons

5. Patients requiring anxiolysis, sedation, or general anesthesia

6. Patients unable to keep dental appointments or return for dental appointments

7. Patients who do not meet inclusion criteria

8. Patients who experience a missed block (IANB) during injection