Clinical trial NCT02266160: Treating Tinnitus Using Eutectic Mixture of Local Anesthetics (EMLA) 5% Cream
Official title: EMLA 5% as a Treatment for Tinnitus and Its Accompanied Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinnitus
Keywords: tinnitus
local anaesthetic
EMLA cream 5%
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: questionnaire results- Beck depression questionnaire
timeFrame: after 4 days of treatment
measure: questionnaire results- Pittsburgh sleep quality index
timeFrame: after 4 days of treatment
measure: questionnaire results- tinnitus handicap inventory
timeFrame: after 4 days of treatment
Secondary outcomes:
measure: questionnaire results - Beck depression questionnaire
timeFrame: 2 weeks after the beginning of treatment
measure: questionnaire results- Pittsburgh sleep quality index
timeFrame: 2 weeks after the beginning of treatment
measure: questionnaire results- tinnitus handicap inventory
timeFrame: 2 weeks after the beginning of treatment
Other outcomes:
Locations:
Study officials:
affiliation: ENT department , "Haemek" hodpital, Afula, ISRAEL
name: salim mazzawi, MD
role: STUDY_CHAIR
References: