drugset / Trial / NCT06128590

Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain

NCT06128590

Completed 50 enrolled University of Nove de Julho
RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. The control group underwent the standard anesthetic procedure, while the experimental group received the application of an infrared laser (100mW at 808nm, 8J at a single point) immediately before anesthesia, at the site of the intended needle puncture. Both groups underwent the same anesthetic procedure, administered by the same operator. The outcome evaluator and the patient were blind to the FBM application. The primary outcome of the study focused on pain experienced at the time of needle insertion, assessed using the Visual Analogue Scale (VAS) during the needle's introduction. Secondary outcomes encompassed anxiety levels, measured using the Beck questionnaire, anesthetic onset time determined through the electric pulp test, the number of anesthetics required for the procedure, and the necessity for supplementary anesthesia.

Timeline

Start
2023-02-15
Primary completion
2024-02-20
Completion
2024-02-20

Drugs

EvaluationDrugModalityDoseRoute
Background Epinephrine Other / unclassified 0.018 mg
Background Mepivacaine Other / unclassified 36 mg

Indications

No indication recorded.