CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
Intra-tympanic injection of drugs +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03265197
NCT03265197Phase 1Completed

Evaluation of Adding Lidocaine to Dexamethasone in Intra-tympanic Injection for Management of Tinnitus

saad elzayat·interventional·Posted Aug 29, 2017·Updated Aug 29, 2017

In Brief

A Phase 1 clinical trial evaluating Intra-tympanic injection of drugs and Data management of intratympanic drugs for Tinnitus. Completed, enrolled 44 participants.

Detailed Summary

Importance; Tinnitus is a heterogeneous diagnosis that may occur alone, in the presence of hearing loss or as a component of other disorders and can be quite disabling. Intratympanic injections of medications recently proved to have role in management of tinnitus. The investigators report on our experience with the use of intratympanic injection of Lidocaine as local anesthetic which potentiate the action of dexthamesasone in treatment of tinnitus without adding potential risks of inner ear Objective; to describe the effect of Lidocaine as local anesthetic may potentiate the action of dexthamesasone intratympanic injection in treatment of tinnitus without adding potential risks of inner ear Design, Setting, participants ; For this single tertiary center( Tanta University Hospital ) prospective case series, the investigators included 44 patients divided into two groups (A and B) 22 patients in each group suffering from tinnitus between March 2015 and October 2015 Intervention; Under local anesthesia 22 patients were subjected to intratympanic injection with combined Lidocaine 2% and dexamethasone with ratio (1:1), in the group A, and 22 patients in the other group B were subjected to intratympanic injection with dexamethasone only , this process was repeated 3 times for 3 successive weeks. Main Outcome and Measures; the primary outcome is self-reported significant improve in tinnitus in group A more in group B without adding significant damage of inner ear

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 29, 2017
Enrollment StartMar 1, 2015
Primary CompletionOct 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.8 years ago

Interventions

Intra-tympanic injection of drugsdrug

Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus

Data management of intratympanic drugsother

intervention by statistical analysis of Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus