drugset / Trial / NCT05757648

Buffered Local Anesthetic

NCT05757648 ↗

Phase 4 Completed 20 enrolled University Hospitals Cleveland Medical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-08
Primary completion
2023-06-12
Completion
2023-06-12

Outcome

Mixed primary results

registry analysis (superiority test); Buffered Anesthetic Side/Non-buffered Anesthetic Side; p = 0.005; Mixed Models Analysis NCT05757648 ↗

registry analysis (superiority test); Buffered Anesthetic Side/Non-buffered Anesthetic Side; p = 0.775; Mixed Models Analysis NCT05757648 ↗

registry analysis (superiority test); Buffered Anesthetic Side/Non-buffered Anesthetic Side; p = 0.682; Mixed Models Analysis NCT05757648 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Buffered Anesthetic Unknown 8.4 % —
Background Epinephrine Other / unclassified — —
Background Lidocaine Other / unclassified 2 % —

Indications

No indication recorded.