Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection
Status unconfirmed · Early Phase 1
Conditions studied: Intratympanic Steroid Injection, Idiopathic Sudden Sensorineural Hearing Loss, Meniere Disease
In brief
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.
Key facts
- Study ID
- NCT04794842
- Run by
- Our Lady of the Lake Hospital
- People needed
- 80
- Starts
- 2021-08-01
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2023-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Having a current tympanic membrane perforation
- Adults unable to sign written consent
- Individuals less than 18 years of age
- Pregnant women
- Prisoners
Where it is running
- Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States
Full record on ClinicalTrials.gov
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