N/A N=32 Randomized Double-blind Diagnostic

Action of Intra-auricular Topical Lidocaine on Tinnitus

Tinnitus, Subjective

Bottom Line

View on ClinicalTrials.gov: NCT05711641 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Change in Visual Analogue Scale (VAS) Score — 6.3; 6.3; 5.5; 5.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lidocaine 10 MG/ML (Drug); Distilled water (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Sao Paulo General Hospital
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Visual Analogue Scale (VAS) Score	6.3; 6.3; 5.5; 5.2	—
PRIMARY Change in Tinnitus Loudness	7.2; 6.4; 5.6; 4.6	—
PRIMARY Change in Minimum Masking Level (MML)	4; 4.8; 3.7; 3.8	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05711641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.