Action of Intra-auricular Topical Lidocaine on Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

Action of Intra-auricular Topical Lidocaine on Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711641
• Other study ID #: 5562868
• Status: Completed
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Lidocaine 10 MG/ML
Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
• Distilled water
Application of distilled water in the external auditory canal of tinnitus patients.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analogue Scale Pontuation	escla ranging from 0 to 10 points used to measure the intensity of tinnitus, where zero corresponds to the absence of tinnitus perception and 10 corresponds to the largest volume that the patient imagines that tinnitus may have.	Change in VAS pontuation from immediately before substance aplication at 5 minutes after.
Secondary	Change in Tinnitus loudness	Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure tinnitus intensity. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the tinnitus loudness is defined.	Change in tinnitus loudness from immediately before substance aplication at 5 minutes after.