Pain Perception Associated With Administration of Buffered Lidocaine Versus Conventional Lidocaine in the Pediatric Dental Patient

2019-0408

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.

2019-11-11

2021-12-17

2022-03-01

Completed

Early phase I

64

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study has been designed as a longitudinal, double blind, crossover study. Specifically, a split mouth design will be implemented to investigate if there is a significant difference in pain perception between administering buffered local anesthesia versus conventional local anesthesia in a pediatric patient.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Designated Investigators will randomize participants and prepare the local anesthetic with or without buffered solution. The anesthetic will then be given to the care provider at time of procedure. The care provider and participant will not know if the buffered solution has been added or not.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

2023-04-07