Clinical trial

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

Name
Tetracaine_vs_Phenol
Description
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.
Trial arms
Trial start
2021-08-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Tetracaine 5% drops
same as information in the arm/group description
Arms:
Tetracaine
Phenol 90% concentration
same as information in the arm/group description
Arms:
Phenol
Size
80
Primary endpoint
Difference in Pain Score
Immediately following the procedure to 6 months from procedure
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-Blinded Randomized Cohort', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Intervention choice blinded to the patient', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2023-10-31

1 organization

2 products

3 indications

Product
Tetracaine
Product
Phenol