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

NCT04794842 | Unknown Early Phase 1

• 1 other identifier: Tetracaine_vs_Phenol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Difference in Pain Score

  Evaluate any differences in pain scores assessed pre/post intervention and between the two topical anesthetics used prior to the intratympanic steroid injection

  Immediately following the procedure to 6 months from procedure

Secondary Outcomes (1)

• 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

Study Arms (2)

Tetracaine

ACTIVE COMPARATOR

Patients will be positioned in supine position at this time 0.5% tetracaine drops will be used to fill the ear canal. Tetracaine will then be allowed to stay in place for approximately 10 to 15 minutes with the patient's head positioned with affected ear up. After this, using an operative microscope the drops will be removed from the ear canal with suction.

Drug: Tetracaine 5% drops

Phenol

ACTIVE COMPARATOR

Patients will be positioned in supine position and tympanic membrane visualized with operative microscope. Phenol applicator will be used to topically apply 90% phenol to the injection site (posterior/Inferior aspect of tympanic membrane).

Drug: Phenol 90% concentration

Interventions

Tetracaine 5% drops DRUG

same as information in the arm/group description

Tetracaine

Phenol 90% concentration DRUG

same as information in the arm/group description

Phenol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead
• Louisiana State University Health Sciences Center - New Orleans: collaborator

Study Sites (1)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (11)

• Filipo R, Attanasio G, Russo FY, Viccaro M, Mancini P, Covelli E. Intratympanic steroid therapy in moderate sudden hearing loss: a randomized, triple-blind, placebo-controlled trial. Laryngoscope. 2013 Mar;123(3):774-8. doi: 10.1002/lary.23678. Epub 2013 Feb 1.

  PMID: 23378346 BACKGROUND

• Wu HP, Chou YF, Yu SH, Wang CP, Hsu CJ, Chen PR. Intratympanic steroid injections as a salvage treatment for sudden sensorineural hearing loss: a randomized, double-blind, placebo-controlled study. Otol Neurotol. 2011 Jul;32(5):774-9. doi: 10.1097/MAO.0b013e31821fbdd1.

  PMID: 21646929 BACKGROUND

• Leng Y, Liu B, Zhou R, Liu J, Liu D, Zhang SL, Kong WJ. Repeated courses of intratympanic dexamethasone injection are effective for intractable Meniere's disease. Acta Otolaryngol. 2017 Feb;137(2):154-160. doi: 10.1080/00016489.2016.1224920. Epub 2016 Sep 21.

  PMID: 27650470 BACKGROUND

• McRackan TR, Best J, Pearce EC, Bennett ML, Dietrich M, Wanna GB, Haynes DS, Labadie RF. Intratympanic dexamethasone as a symptomatic treatment for Meniere's disease. Otol Neurotol. 2014 Oct;35(9):1638-40. doi: 10.1097/MAO.0000000000000500.

  PMID: 25188506 BACKGROUND

• Belhassen S, Saliba I. Pain assessment of the intratympanic injections: a prospective comparative study. Eur Arch Otorhinolaryngol. 2012 Dec;269(12):2467-73. doi: 10.1007/s00405-011-1897-z. Epub 2011 Dec 28.

  PMID: 22203120 BACKGROUND

• Silverstein H, Call DL. Tetracaine base. An effective surface anesthetic for the tympanic membrane. Arch Otolaryngol. 1969 Aug;90(2):150-1. doi: 10.1001/archotol.1969.00770030152010. No abstract available.

  PMID: 5794873 BACKGROUND

• Kumar R, Banerjee A. Myringotomy and ventilation tube insertion with minims tetracaine drops. Eur Arch Otorhinolaryngol. 2011 Oct;268(10):1533-4. doi: 10.1007/s00405-011-1654-3. Epub 2011 Jun 17.

  PMID: 21681571 BACKGROUND

• Hoffman RA, Li CL. Tetracaine topical anesthesia for myringotomy. Laryngoscope. 2001 Sep;111(9):1636-8. doi: 10.1097/00005537-200109000-00027.

  PMID: 11568619 BACKGROUND

• Robertson A, Whitwell R, Osborne J. Is phenol a safe local anaesthetic for grommet insertion? J Laryngol Otol. 2006 Jan;120(1):20-3. doi: 10.1017/S0022215105005840.

  PMID: 16375777 BACKGROUND

• Weisskopf A. Phenol anesthesia for myringotomy. Laryngoscope. 1983 Jan;93(1):114. doi: 10.1288/00005537-198301000-00022. No abstract available.

  PMID: 6823169 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

MeSH Terms

Conditions

Meniere Disease

Interventions

Tetracaine; Phenol

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Intervention choice blinded to the patient
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Research Director

Model Details: Single-Blinded Randomized Cohort

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)