Clinical trial NCT04794842: Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
Official title: Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Intratympanic Steroid Injection
Idiopathic Sudden Sensorineural Hearing Loss
Meniere Disease
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center - New Orleans
First posted: 2021-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-Blinded Randomized Cohort
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in Pain Score
timeFrame: Immediately following the procedure to 6 months from procedure
Secondary outcomes:
measure: Statistical difference in tympanic membrane perforation presence or absence after the steroid injection procedure when using either tetracaine or phenol as the local anesthetic
timeFrame: Immediately following the procedure to 6 months from procedure
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital
state: Louisiana
Study officials:
References:
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