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

Early Phase 1

Active, not recruiting

• Conditions: Intratympanic Steroid Injection; Idiopathic Sudden Sensorineural Hearing Loss; Meniere Disease
• Interventions: Drug: Tetracaine 5% drops; Drug: Phenol 90% concentration

• Registration Number: NCT04794842
• Lead Sponsor: Our Lady of the Lake Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tetracaine	Tetracaine 5% drops	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.
Phenol	Phenol 90% concentration	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Our Lady of the Lake Hospital; 🇺🇸 Baton Rouge, Louisiana, United States