Buffered Local Anesthetic

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2023-06-12

Brief Summary

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The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.

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Detailed Description

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Conditions

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Dental Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients serve as their own control. One side of the mouth is buffered, one side is non-buffered

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participant and Care provider is blinded as to which side is buffered and which is non-buffered

Study Groups

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Buffered Anesthetic Side/Non-buffered Anesthetic Side

Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.

Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.

Group Type EXPERIMENTAL

Non-buffered Anesthetic

Intervention Type DRUG

non-buffered LA, 2% lidocaine with epinephrine 1:100,000

Buffered Anesthetic

Intervention Type DRUG

A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.

Onset

Intervention Type DEVICE

The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.

Interventions

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Non-buffered Anesthetic

non-buffered LA, 2% lidocaine with epinephrine 1:100,000

Intervention Type DRUG

Buffered Anesthetic

A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.

Intervention Type DRUG

Onset

The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy children or children with mild controlled systemic illness
* Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration

Exclusion Criteria

* Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
* Antibiotic premedication requirement
* History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
* Has signs of dental pain, odontogenic abscess or facial cellulitis
* Allergy to local anesthetics or sulfites

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes