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

NCT02266160 | Completed Phase 4 DMC

• 1 other identifier: 0055-14
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinnitus

Keywords

tinnitus; local anaesthetic; EMLA cream 5%

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• questionnaire results - Beck depression questionnaire

  2 weeks after the beginning of treatment

• questionnaire results- Pittsburgh sleep quality index

  2 weeks after the beginning of treatment

• questionnaire results- tinnitus handicap inventory

  2 weeks after the beginning of treatment

Study Arms (2)

1

EXPERIMENTAL

71 tinnitus patients treated with 2 gram EMLA 5% cream a day for 4 days, 4 hours a day. we will compare the questionnaires results before and after 4 days of treatment to see whether EMLA cream changes the degree of suffer from tinnitus

Drug: EMLA cream 5%

2

SHAM COMPARATOR

71 tinnitus patients using cetomacrogol cream (lotion cream, does not contain any drug) for 4 days. these patients will fulfill the questionnaires as the investigational group.

Other: cetomacrogol cream (lotion cream)

Interventions

EMLA cream 5% DRUG

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.

Also known as: no other names

1

cetomacrogol cream (lotion cream) OTHER

lotion cream that does not contain active drug. has no contraindications

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• salim mazzawi, MD

  ENT department , "Haemek" hodpital, Afula, ISRAEL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 16, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share