Use of Vibration Anesthesia Device in Intratympanic Injections

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 25, 2020

Primary Completion Date

August 25, 2021

Study Completion Date

December 25, 2021

Conditions
Intratympanic InjectionsSudden Hearing Loss
Interventions
DEVICE

Vibration Anesthesia Device (VAD)

In conclusion, induction of anesthesia with VAD in patients treated with ITS provided pain palliation in a similar way to other local anesthetic techniques. Moreover, 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. Our study will shed light on different techniques such as the application of ventilation tube in anesthesia with VAD.

DRUG

local anesthetic cream

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

DRUG

lidocaine spray

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

OTHER

saline drops

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

Trial Locations (1)

65000

van yuzuncu yil university, Bardakçı, Yüzüncü Yıl Ünv., 65080 Tuşba/Van, Van

All Listed Sponsors
lead

Yuzuncu Yıl University

OTHER

NCT06885723 - Use of Vibration Anesthesia Device in Intratympanic Injections | Biotech Hunter | Biotech Hunter