Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection

Study Overview
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Brief Summary
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Intratympanic steroid injections are an accepted treatment for Meniere's disease and idiopathic sudden sensorineural hearing loss. This treatment is typically performed using local topical anesthesia. There is very limited research on the differences of medications and application procedures effect on patients' pain during the procedure.Topical Tetracaine solution and topical phenol have been shown to be effective as local anesthesia for the tympanic membrane when used for myringotomy. Currently there is no consensus on medication and technique however focally applied phenol is the more widely used technique. We believe this study can provide valuable information given the disadvantages of topical phenol including burning upon application as well as possible increase in persistent tympanic membrane perforation. The objectives are to determine the effectiveness of tetracaine drops for local anesthesia for intratympanic steroid injections compared to focal topical phenol application and to identify if tetracaine drops provides adequate anesthesia for intratympanic steroid injection with less pain on application than focal phenol.

Official Title
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Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection

Conditions
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Intratympanic Steroid Injection, Idiopathic Sudden Sensorineural Hearing Loss, Meniere Disease

Intervention / Treatment
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* Drug: Tetracaine 5% drops
* Drug: Phenol 90% concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects (18 years of age or greater) Diagnosed with Idiopathic Sudden Sensorineural hearing loss or Meniere's disease Care plan includes treatment via intratympanic steroid injection Exclusion Criteria: Having a current tympanic membrane perforation Adults unable to sign written consent Individuals less than 18 years of age Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-Blinded Randomized Cohort
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracaine<br>Patients will be positioned in supine position at this time 0.5% tetracaine drops will be used to fill the ear canal. Tetracaine will then be allowed to stay in place for approximately 10 to 15 minutes with the patient's head positioned with affected ear up. After this, using an operative microscope the drops will be removed from the ear canal with suction. | Drug: Tetracaine 5% drops<br>* same as information in the arm/group description<br>|
| Active Comparator: Phenol<br>Patients will be positioned in supine position and tympanic membrane visualized with operative microscope. Phenol applicator will be used to topically apply 90% phenol to the injection site (posterior/Inferior aspect of tympanic membrane). | Drug: Phenol 90% concentration<br>* same as information in the arm/group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pain Score | Evaluate any differences in pain scores assessed pre/post intervention and between the two topical anesthetics used prior to the intratympanic steroid injection | Immediately following the procedure to 6 months from procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical difference in tympanic membrane perforation presence or absence after the steroid injection procedure when using either tetracaine or phenol as the local anesthetic |  | Immediately following the procedure to 6 months from procedure |