Action of Intra-auricular Topical Lidocaine on Tinnitus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-02

Study Completion Date

2023-06-01

Brief Summary

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The main objective of this clinical trial placebo controled is to evaluate the action of intraauricular topical lidocaine on tinnitus.

The question to be answered is whether lidocaine is superior to placebo (distilled water) in reducing tinnitus intensity when applied topically within the external auditory canal.

Tinnitus intensity will be measured using the visual analog scale and acuphenometry before and after lidocaine or placebo application.

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Detailed Description

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Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months are being evaluated. Exclusion criteria are: otological infection, tympanic membrane perforation, anatomical alteration of the external ear, pulsatile tinnitus, objective tinnitus, known allergy to lidocaine or other topical anesthetic and pregnancy All patients receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized. Only one ear receives the medications and side is defined by the higher intensity of tinnitus, or through draw in the case of symmetrical tinnitus.

The patient is instructed to lie in lateral decubitus, with the ear under study facing upwards and the substances are applied by filling the external auditory canal with lidocaine or distilled water for 5 min. Tinnitus intensity is measured (acuphenometry and VAS) before and after substance application and the variation is compared between lidocaine and placebo.

Conditions

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Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

This is a double blind study. The substances are produced by the same handling pharmacy and delivered in identical vials, only with the information: substance 1 and substance 2.

Study Groups

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Lidocaine 10%

The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and 10% lidocaine is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).

Group Type EXPERIMENTAL

Lidocaine 10 MG/ML

Intervention Type DRUG

Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.

Placebo

The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and distilled water is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).

Group Type PLACEBO_COMPARATOR

Distilled water

Intervention Type DRUG

Application of distilled water in the external auditory canal of tinnitus patients.

Interventions

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Lidocaine 10 MG/ML

Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.

Intervention Type DRUG

Distilled water

Application of distilled water in the external auditory canal of tinnitus patients.

Intervention Type DRUG

Other Intervention Names

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Active substance Placebo

Eligibility Criteria

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Inclusion Criteria

* Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months

Exclusion Criteria

* Otological infection
* Tympanic membrane perforation
* Anatomical alteration of the external ear
* Pulsatile tinnitus
* Objective tinnitus
* Known allergy to lidocaine or other topical anesthetic and pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No