NCT05267938

Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed to access pain of local anesthesia after using a topical anesthetic associated or not with prior application of microneedles to the palatal mucosa region

Detailed description

A randomized, crossover, double-blind, two-sessions clinical trial with 30 male volunteers was performed by applying a microneedle patch and as a negative control the an identical patch but without microneedles sticking out and after the topical anesthetic was applied for in one session 2 minutes and the other session 5 minutes and the investigators evaluated the pain of needle introduction and the injection of the anesthetic. The application force of the microneedles was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), in these two different moments, introduction of the needle and injection of the anesthetic.

Conditions

• Oral Cavity Disease

Interventions

Type	Name	Description
DRUG	Topical Anesthetic	The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa
DRUG	Local anesthetic	After the pre-treatment with microneedles and the use of topical anesthetic, the needle and injection of local anesthetic was inserted and pain was evaluated

Timeline

• Start date: 2019-08-01
• Primary completion: 2019-10-30
• Completion: 2020-01-30
• First posted: 2022-03-07
• Last updated: 2022-03-21

Locations

1 site across 1 country: Brazil