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Intratympanic Steroid InjectionEarly Phase 1NCT04794842

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

A Early Phase 1 study testing Tetracaine 5% drops and Phenol 90% concentration in people with Intratympanic Steroid Injection and Idiopathic Sudden Sensorineural Hearing Loss, run by Our Lady of the Lake Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tetracaine 5% drops and Phenol 90% concentration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Aug 2021to 31 Dec 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Having a current tympanic membrane perforation
  • Adults unable to sign written consent
  • Individuals less than 18 years of age
  • Pregnant women
  • Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

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.

Being tested
Tetracaine 5% drops, Phenol 90% concentration
Medical subject headings
Meniere Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetracaine 5% dropsDrug

    same as information in the arm/group description

  • Phenol 90% concentrationDrug

    same as information in the arm/group description

Study groups in NCT04794842
Study groupRoleWhat they receive
TetracaineActive comparatorPatients 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.
Receives: Drug: Tetracaine 5% drops
PhenolActive comparatorPatients 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).
Receives: Drug: Phenol 90% concentration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Immediately following the procedure to 6 months from procedure

Secondary outcomes (1)

  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

    Measured: Immediately following the procedure to 6 months from procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2021
  2. Study start1 Aug 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-Blinded Randomized Cohort
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04794842
Sponsor's protocol ID
Tetracaine_vs_Phenol
Status last verified
Oct 2023
First submitted
9 Mar 2021
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23378346

  • 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.

    PubMed 21646929

  • 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.

    PubMed 27650470

  • 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.

    PubMed 25188506

  • 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.

    PubMed 22203120

  • 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.

    PubMed 5794873

  • 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.

    PubMed 21681571

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

    PubMed 11568619

  • 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.

    PubMed 16375777

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

    PubMed 6823169

  • 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.

    PubMed 22588748

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tetracaine 5% drops and Phenol 90% concentration in people with Intratympanic Steroid Injection and Idiopathic Sudden Sensorineural Hearing Loss, run by Our Lady of the Lake Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Pain Score (time frame: Immediately following the procedure to 6 months from procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04794842, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.

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