N/A
Completed N=32
Action of Intra-auricular Topical Lidocaine on Tinnitus
Tinnitus, Subjective
Source: ClinicalTrials.gov NCT05711641 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Change in Visual Analogue Scale (VAS) Score — 6.3; 6.3; 5.5; 5.2 score on a scale
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.
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 | — |
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
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. Informational only — not medical advice.