NCT04794842

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Our Lady of the Lake Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intratympanic Steroid Injection
• Idiopathic Sudden Sensorineural Hearing Loss
• Meniere Disease

Interventions

Type	Name	Description
DRUG	Tetracaine 5% drops	same as information in the arm/group description
DRUG	Phenol 90% concentration	same as information in the arm/group description

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-03-12
• Last updated: 2023-10-31

Locations

1 site across 1 country: United States