Numbing Agents for Hearing Loss

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Our Lady of the Lake Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with Meniere's disease or sudden sensorineural hearing loss who need intratympanic steroid injections can join. It's not for those under 18, pregnant women, prisoners, people unable to consent in writing, or anyone with a current eardrum perforation.

Inclusion Criteria

Your treatment plan involves getting steroid injections in your ear.

You are an adult diagnosed with sudden hearing loss or Meniere's disease.

You have been diagnosed with sudden hearing loss or Meniere's disease.

Exclusion Criteria

You have a hole in your eardrum right now.

Adults unable to sign written consent

Individuals less than 18 years of age

See 2 more

Treatment Details

Interventions

Phenol 90% concentration (Local Anesthetic)
Tetracaine 5% drops (Local Anesthetic)

Trial OverviewThe trial is testing if Tetracaine drops are better than Phenol for numbing the ear during steroid injections. Patients will receive one of these anesthetics before their treatment to see which causes less pain and is more effective.

Participant Groups

2Treatment groups

Active Control

Group I: TetracaineActive Control1 Intervention

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.

Group II: PhenolActive Control1 Intervention

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).