Buffered Local Anesthetic

Study Overview
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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.

Official Title
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Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study

Conditions
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Dental Pain

Intervention / Treatment
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* Drug: Non-buffered Anesthetic
* Drug: Buffered Anesthetic
* Device: Onset


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buffered Anesthetic<br>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. | Drug: Buffered Anesthetic<br>* 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.<br>Device: Onset<br>* 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.<br>|
| Active Comparator: Non-buffered Anesthetic<br>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. | Drug: Non-buffered Anesthetic<br>* non-buffered LA, 2% lidocaine with epinephrine 1:100,000<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score as measured by the behavior pain scale | The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures. | Up to 10 minutes | 
| Change in heart rate as measured by as measured by medical record |  | Baseline, Up to 10 minutes | 
| Change in blood pressure as measured by medical record |  | Baseline, Up to 10 minutes | 
| Change in CO2 level as measured by medical record |  | Baseline, Up to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental surgery, Deep sedation