NCT05757648

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Non-buffered Anesthetic	non-buffered LA, 2% lidocaine with epinephrine 1:100,000
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.
DEVICE	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.

Timeline

• Start date: 2020-12-08
• Primary completion: 2023-06-12
• Completion: 2023-06-12
• First posted: 2023-03-07
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study