Numbing Agents for Hearing Loss

Phase < 1

Waitlist Available

Research Sponsored by Our Lady of the Lake Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following the procedure to 6 months from procedure

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether or not a numbing drop (tetracaine) is more effective and less painful than a numbing agent applied directly to the eardrum (phenol) for people getting a steroid injection into the ear for Meniere's disease or idiopathic sudden sensorineural hearing loss.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include burning sensation upon application of phenol and potential persistent eardrum perforation. Side effects from tetracaine may include local discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following the procedure to 6 months from procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following the procedure to 6 months from procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following the procedure to 6 months from procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in Pain Score

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

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