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

NCT03265197 | Completed Phase 1

• 1 other identifier: KafrelsheikhU
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Tinnitus

Keywords

Tinnitus; Intra-tympanic; Lidocaine; Dexamethasone

Outcome Measures

Primary Outcomes (2)

• measuring tinnitus scales improvements by using dexmethsone alone and by using combined lidocaine and tinnitus

  using measuring indice as Tinnitus Handicap Inventory (THI)self-perceived tinnitus handicap severity.

  6 months

• measuring medication complication and side effect by using hearing test indicators

  using hearing indices as pure tone audiometry (PTA) ,

  6 months

Study Arms (2)

Intratympanic injection of drugs;

EXPERIMENTAL

intervention by Intratympanic injection of drugs in two studied groups; group A, injection of combined 2 drugs( lidocaine and dexamethasone) and group B, injection of one drug (dexamethasone only).

Drug: Intra-tympanic injection of drugs

Data management of Intratympanic drugs

ACTIVE COMPARATOR

intervention by Manage data of two study group as blind statistical between group A, injection of combined 2 drugs( lidocaine and dexamethasone) and group B, injection of one drug (dexamethasone only).

Other: Data management of intratympanic drugs

Interventions

Intra-tympanic injection of drugs DRUG

Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus

Also known as: Lidocaine in tinnitus

Intratympanic injection of drugs;

Data management of intratympanic drugs OTHER

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

Data management of Intratympanic drugs

Eligibility Criteria

• Age: 30 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Idiopathic subjective non-pulsatile tinnitus (IST)

You may not qualify if:

• Extreme age, pulsatile tinnitus, objective tinnitus and ear inflammation.

Sponsors & Collaborators

• saad elzayat: lead

Related Publications (6)

• Adams PF, Hendershot GE, Marano MA; Centers for Disease Control and Prevention/National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10. 1999 Oct;(200):1-203.

  PMID: 15782448 BACKGROUND

• She W, Dai Y, Du X, Chen F, Ding X, Cui X. Treatment of subjective tinnitus: a comparative clinical study of intratympanic steroid injection vs. oral carbamazepine. Med Sci Monit. 2009 Jun;15(6):PI35-9.

  PMID: 19478715 BACKGROUND

• Moller AR. Pathophysiology of tinnitus. Otolaryngol Clin North Am. 2003 Apr;36(2):249-66, v-vi. doi: 10.1016/s0030-6665(02)00170-6.

  PMID: 12856295 BACKGROUND

• Meyer T. Intratympanic treatment for tinnitus: a review. Noise Health. 2013 Mar-Apr;15(63):83-90. doi: 10.4103/1463-1741.110285.

  PMID: 23571297 BACKGROUND

• Elzayat S, El-Sherif H, Hegazy H, Gabr T, El-Tahan AR. Tinnitus: Evaluation of Intratympanic Injection of Combined Lidocaine and Corticosteroids. ORL J Otorhinolaryngol Relat Spec. 2016;78(3):159-66. doi: 10.1159/000445774. Epub 2016 Jun 1.

  PMID: 27245783 BACKGROUND

• Dodson KM, Sismanis A. Intratympanic perfusion for the treatment of tinnitus. Otolaryngol Clin North Am. 2004 Oct;37(5):991-1000. doi: 10.1016/j.otc.2004.03.003.

  PMID: 15474106 RESULT

MeSH Terms

Conditions

Tinnitus

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor and lecturer of ORL

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: August 29, 2017
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share