Status:
COMPLETED
Buffered Lidocaine in the Pediatric Dental Patient
Lead Sponsor:
Geisinger Clinic
Conditions:
Pediatric Dentistry
Eligibility:
All Genders
4-17 years
Phase:
PHASE4
Brief 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. Buffere...
Detailed Description
This project's primary aim is to evaluate pain perception in buffered vs non-buffered local anesthesia in children undergoing routine dental treatment. The secondary aim is to evaluate if the buffered...
Eligibility Criteria
Inclusion
- 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
- Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis
- Patients 4-17 years of age
- Patients classified as ASA I or ASA II
- Patients of parents who can read, write and give consent in English
Exclusion
- Patients with allergy to local anesthetic
- Patients who are pregnant or nursing
- Patients with cardiac concerns or contraindications to epinephrine
- Patients unable to undergo dental treatment in the clinic for behavior or medical reasons
- Patients requiring anxiolysis, sedation, or general anesthesia
- Patients unable to keep dental appointments or return for dental appointments
- Patients who do not meet inclusion criteria
- Patients who experience a missed block (IANB) during injection
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04055116
Start Date
November 11 2019
End Date
March 1 2022
Last Update
April 7 2023
Active Locations (1)
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1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822