Idiopathic Sudden Sensorineural Hearing Loss, Intratympanic Steroid Injection, Meniere Disease
Conditions
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.
Interventions
same as information in the arm/group description
DRUGPhenol 90% concentration
same as information in the arm/group description
Sponsors
Louisiana State University Health Sciences Center - New Orleans
Our Lady of the Lake Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Intervention choice blinded to the patient
Intervention model description
Single-Blinded Randomized Cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed