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CC BY 4.0 · Int Arch Otorhinolaryngol 2025; 29(04): s00451810028
DOI: 10.1055/s-0045-1810028
Original Research

Effect of Topical Intra-Auricular Lidocaine on Tinnitus: A Randomized Double-Blind Placebo-Controlled Study

Authors

  • Tatiane Vacaro Campos 

    1   Department of Ophthalmology and Otorhinolaryngology, Faculty of Medicine, Hospital das Clínicas da Universidade de São Paulo, São Paulo, SP, Brazil

  • Ricardo Ferreira Bento 

    1   Department of Ophthalmology and Otorhinolaryngology, Faculty of Medicine, Hospital das Clínicas da Universidade de São Paulo, São Paulo, SP, Brazil

  • Jeanne Oticica

    1   Department of Ophthalmology and Otorhinolaryngology, Faculty of Medicine, Hospital das Clínicas da Universidade de São Paulo, São Paulo, SP, Brazil

  • Maíra Said Jabour

    1   Department of Ophthalmology and Otorhinolaryngology, Faculty of Medicine, Hospital das Clínicas da Universidade de São Paulo, São Paulo, SP, Brazil

  • Nathália Távora

    2   Department of Otorhinolaryngology, Hospital Universitário Cassiano Antônio, Universidade Federal do Espírito Santo, Vitória, ES, Brazil

  • Isabela Jardim

    1   Department of Ophthalmology and Otorhinolaryngology, Faculty of Medicine, Hospital das Clínicas da Universidade de São Paulo, São Paulo, SP, Brazil

  • Cristiane Leite de Marchi

    3   Centro de Audiologia (Audiocenter), São Paulo, SP, Pinheiros, Brazil

  • Robinson Koji Tsuji

    1   Department of Ophthalmology and Otorhinolaryngology, Faculty of Medicine, Hospital das Clínicas da Universidade de São Paulo, São Paulo, SP, Brazil

Funding This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001.Clinical Trials Registration: Trial Registration Number NCT05711641
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Abstract

Introduction

Tinnitus is a prevalent symptom and has no proven effective treatment. Clinical observations that some patients reported significantly improved tinnitus after topical ear drop administration of lidocaine motivated research on this drug.

Objective

Evaluate the action of topical intra-auricular 10% lidocaine in suppressing tinnitus compared to placebo.

Methods

This was a randomized, crossover, double-blind, placebo-controlled clinical trial. The variations of the visual analog scale (VAS), tinnitus loudness, and the minimum masking level (MML) after intra-auricular lidocaine 10% were compared with a placebo. The same variables were compared with some sample features.

Results

There was no statistically significant difference between the action of lidocaine and placebo in tinnitus variation measured by VAS (p = 0.361), tinnitus loudness (p = 0.850), and MML. (p = 0.213). The VAS variation was statistically lower in patients with any hearing loss (p = 0.005); the tinnitus loudness variation was higher in patients with tinnitus modulation (p = 0.049) and lower in patients with any hearing loss (p = 0.045). The MML variation was lower in patients with bruxism/TMD (p = 0.026).

Conclusion

In this study the action of lidocaine on the variation of tinnitus intensity was similar to placebo. We believe that the use of manipulated medication may have interfered in the outcome and that the large number of patients with positive response to placebo should be investigated in further studies.

Keywords

tinnitus - lidocaine - external acoustic meatus - local anesthetics - topical administration - clinical trial

Authors' Contributions

TVC: conceptualization, methodology, investigation, data curation and writing; RFB: conceptualization and supervision; JO: conceptualization; MSJ: investigation; NT: investigation; IJ: supervision; CLDM: investigation; RKT: conceptualization and supervision.


Data Availability Statement

Data supporting the results of this study are available upon a reasonable request from the corresponding author.


Supplementary Material



Publication History

Received: 16 October 2023

Accepted: 24 May 2025

Article published online:
16 October 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/)

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Bibliographical Record
Tatiane Vacaro Campos, Ricardo Ferreira Bento, Jeanne Oticica, Maíra Said Jabour, Nathália Távora, Isabela Jardim, Cristiane Leite de Marchi, Robinson Koji Tsuji. Effect of Topical Intra-Auricular Lidocaine on Tinnitus: A Randomized Double-Blind Placebo-Controlled Study. Int Arch Otorhinolaryngol 2025; 29: s00451810028.
DOI: 10.1055/s-0045-1810028