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

Meniere Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04794842
• Other study ID #: Tetracaine_vs_Phenol
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Our Lady of the Lake Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tetracaine 5% drops
same as information in the arm/group description
• Phenol 90% concentration
same as information in the arm/group description

Locations

Country	Name	City	State
United States	Our Lady of the Lake Hospital	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Our Lady of the Lake Hospital	Louisiana State University Health Sciences Center - New Orleans

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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