NCT05711641

Action of Intra-auricular Topical Lidocaine on Tinnitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tinnitus, Subjective

Interventions

Type	Name	Description
DRUG	Lidocaine 10 MG/ML	Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
DRUG	Distilled water	Application of distilled water in the external auditory canal of tinnitus patients.

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-02-03
• Last updated: 2024-08-30
• Results posted: 2024-08-30

Locations

1 site across 1 country: Brazil