CompletedNot Applicable

Use of Vibration Anesthesia Device in Intratympanic Injections

Turkey (Türkiye)40 participantsStarted 2020-07-25

Plain-language summary

SUMMARY Intratympanic injections commonly cause pain in the patients. Intratympanic steroid injection (ITS) application can be performed by direct injection without anesthesia or with local anesthesia induced by lidocaine spray, lidocaine injection, topical phenol, pantocaine, EMLA cream (lidocaine+prilocaine) or vibration anesthesia device (VAD). The advantage of VAD application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. In addition, inducing anesthesia with VAD can be considered as an alternative method in patients allergic to drugs.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18-70 years with idiopathic sudden sensorineural hearing loss Exclusion Criteria: * History of otologic surgery, * Recent ototoxic drug use, * Congenital inner ear malformation, * History of chemoradiotherapy due to malignant neoplasia, * Presence of acute or chronic otitis media, * Age under 18 years, over 70 years * History of local anesthesia allergy, * Coagulation abnormality, * Pregnant and lactating women, * Hearing cases with other neurootological diseases

What they're measuring

Visual Analogue Scale(VAS)

Timeframe: 56 weeks

Eleven-Point Numeric Rating Scale(NRS-11)

Timeframe: 56 weeks

Four-Category Verbal Rating Scale(VRS-4)

Timeframe: 56 weeks

Trial details

NCT IDNCT06885723

SponsorYuzuncu Yil University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-25

View on ClinicalTrials.gov More Intratympanic Injections trials