Buffered Local Anesthetic

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05757648

Enrollment

Registered

2023-03-07

Start date

2020-12-08

Completion date

2023-06-12

Last updated

2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain

Keywords

Dental surgery, Deep sedation

Brief summary

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.

Interventions

DRUGNon-buffered Anesthetic

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

DRUGBuffered 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.

DEVICEOnset

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Score as Measured by the Behavior Pain Scale	Up to 10 minutes	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.
Change in Heart Rate as Measured by as Measured by Medical Record	Baseline, Up to 10 minutes	—
Change in Diastolic Blood Pressure as Measured by Medical Record	Baseline, Up to 10 minutes	—
Change in Systolic 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	—
Change in Oxygen Saturation Level as Measured by Medical Record	Baseline, Up to 10 minutes	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000 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. 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.	20
Total	20

Arm

Count

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

Total

Baseline characteristics

Characteristic	Buffered Anesthetic Side/Non-buffered Anesthetic Side	—
Age, Continuous	4.6 years STANDARD_DEVIATION 1.1	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	12 Participants	—
Sex: Female, Male Male	8 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 20
other Total, other adverse events	0 / 20
serious Total, serious adverse events	0 / 20