MedTrace Logo

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

NCT04794842 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-31

No results posted yet for this study

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

DRUG

Tetracaine 5% drops

same as information in the arm/group description

DRUG

Phenol 90% concentration

same as information in the arm/group description

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center - New Orleans

    collaborator UNKNOWN

  • Our Lady of the Lake Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794842 on ClinicalTrials.gov