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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-01-30

Brief Summary

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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

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Detailed Description

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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

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Oral Cavity Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Every volunteers has received bilateral pre-treatment with microneedles or the negative control in the palatal mucosa, in both sessions, which each session was 2 minutes of topical anesthetic or 5 minutes.

Study Groups

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Microneedles

Microneedles is with 750μm of height in order to prepare the palatal mucosa to receive the topical anesthetic

Group Type EXPERIMENTAL

Topical Anesthetic

Intervention Type DRUG

The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa

Local anesthetic

Intervention Type DRUG

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

patch flat

The same device as the microneedles but without microneedles

Group Type SHAM_COMPARATOR

Topical Anesthetic

Intervention Type DRUG

The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa

Local anesthetic

Intervention Type DRUG

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

Interventions

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Topical Anesthetic

The topical anesthetic used in this experimental is EMLA® after the pre-treatment of the palatal mucosa

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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treatment Lidocaine with epinephrine

Eligibility Criteria

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Inclusion Criteria

\- Healthy male

Exclusion Criteria

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes