Treating Tinnitus Using Eutectic Mixture of Local Anesthetics (EMLA) 5% Cream

Tinnitus Clinical Trial

Official title:

EMLA 5% as a Treatment for Tinnitus and Its Accompanied Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266160
• Other study ID #: 0055-14
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2014
• Last updated: February 27, 2018
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators like to learn whether EMLA cream 5% helps tinnitus patients. so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if topical anaesthetics (e.g EMLA cream) helps tinnitus.

The investigators are going to compare 4 days of treatment of EMLA 5% cream Versus (VS.) cetomacrogol cream (water- based lotion cream) in treating tinnitus patients.

Description:

The purpose of the study is to investigate whether EMLA 5% cream decreases tinnitus by comparing pretrial questionnaires to post trial questionnaires.

first we are going to invite tinnitus patients for the first visit. in the first visit we will confirm that the patients is suitable for the trial (no exclusion criteria are present) , perform ear investigation to exclude ear inflammation, perform audiometry to prove sensorineural hearing loss. then the patient will fill 3 questionnaires that reflect the tinnitus severity and show how much the patient does suffer from this conditions. the questionnaires are- beck depression index, tinnitus handicap inventory, Pittsburgh sleep quality index.

Then we will perform randomization: the investigational group will get EMLA 5% cream, the control group will get cetomacrogol cream (a lotion cream).

In the next 4 days the patients (investigational and control groups) will spread the cream for 4 hours a day in the post auricular area of the ear/ ears that suffer/s from tinnitus.

The patient will be instructed to stop the spreading and call the chief investigator When any kind of side effect occurs (topical/ systemic)after 4 days of treatment the patient will come to the clinic once again and fill the same questionnaires. 3 weeks after the beginning of the trial the patient will fill the questionnaires for the third time.

Regarding the questionnaires:

1. Beck depression questionnaire is a 21-questions exam that checks the depression level of the patient. The minimum score is 1 the maximum is 63. The investigators hypotheses states that EMLA cream treatment decreases the Beck questionnaire score

2. Pittsburgh sleep quality index is a 9 questions exam that measure the quality of sleep. the range of results goes between 0-24. The higher the score- the worse is the quality of sleep. The investigators hypotheses states that EMLA treatment improves the results of the Pittsburgh sleep quality questionnaires.

3. Tinnitus handicap inventory estimates the degree that tinnitus affects patients life. it contains 25 questions . The minimum score is 0 and the maximum is 100 . The investigators hypotheses that EMLA cream treatment decreases the score of this questionnaire which means that EMLA cream improves patients quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mature (above 18 years old) patients that suffer tinnitus (unilateral/bilateral) with sensorineural hearing loss

Exclusion Criteria:

• patients that are treated for tinnitus( psychological treatment, hearing aid)

• drugs that affect the CNS

• sensitivity to amide anaesthetic

• hepatic failure

• usage of antiarrhythmic drugs

• severe depression any patients that develops during the trial local/ systemic symptoms such as rash, pain, itching, fever, nervousness,palpitations will be omitted from the study

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• EMLA cream 5%
the interventional group will spread 2 grams (2 m"l) of EMLA cream over the post auricular area. after 4 hours the patient will wash away the cream. the treatment will last 4 days.

Other:
• cetomacrogol cream (lotion cream)
lotion cream that does not contain active drug. has no contraindications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire results- Beck depression questionnaire	Beck depression questionnaire: A 21- questions exam that checks the depression level of the patient. the minimum score is 1 and the maximum score is 63. The investigators hypotheses states that EMLA cream treatment decreases the Beck questionnaire score	after 4 days of treatment
Primary	questionnaire results- Pittsburgh sleep quality index	Pittsburgh sleep quality index : A 9 questions exam that measure the quality of sleep. The range of results goes between 0-24. The higher the score - the worse is the quality of sleep. The investigators hypotheses states that EMLA treatment improves the results of Pittsburgh sleep quality index	after 4 days of treatment
Primary	questionnaire results- tinnitus handicap inventory	tinnitus handicap inventory: estimates the degree that tinnitus affects patients life. It contains 25 questions. The minimum score is 0 and the maximum is 100. The investigators hypotheses that EMLA cream treatment decreases the score of this questionnaire which means that EMLA cream improves patients quality of life	after 4 days of treatment
Secondary	questionnaire results - Beck depression questionnaire	estimation of this questionnaire after 2 weeks of treatment	2 weeks after the beginning of treatment
Secondary	questionnaire results- Pittsburgh sleep quality index	estimation of this questionnaire after 2 weeks of treatment	2 weeks after the beginning of treatment
Secondary	questionnaire results- tinnitus handicap inventory	estimation of this questionnaire after 2 weeks of treatment	2 weeks after the beginning of treatment