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

Our Lady of the Lake Hospital

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Meniere Disease; Intratympanic Steroid Injection; Idiopathic Sudden Sensorineural Hearing Loss

Treatments: Drug: Phenol 90% concentration; Drug: Tetracaine 5% drops

Study type: Interventional

Funder types: Other

Identifiers

NCT04794842

Tetracaine_vs_Phenol

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Tetracaine

Active Comparator group

Description:

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.

Treatment:

Drug: Tetracaine 5% drops

Phenol

Active Comparator group

Description:

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).

Treatment:

Drug: Phenol 90% concentration