Action of Intra-auricular Topical Lidocaine on Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) Score
研究概览
简要总结
The main objective of this clinical trial placebo controled is to evaluate the action of intraauricular topical lidocaine on tinnitus.
The question to be answered is whether lidocaine is superior to placebo (distilled water) in reducing tinnitus intensity when applied topically within the external auditory canal.
Tinnitus intensity will be measured using the visual analog scale and acuphenometry before and after lidocaine or placebo application.
详细描述
Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months are being evaluated. Exclusion criteria are: otological infection, tympanic membrane perforation, anatomical alteration of the external ear, pulsatile tinnitus, objective tinnitus, known allergy to lidocaine or other topical anesthetic and pregnancy All patients receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized. Only one ear receives the medications and side is defined by the higher intensity of tinnitus, or through draw in the case of symmetrical tinnitus.
The patient is instructed to lie in lateral decubitus, with the ear under study facing upwards and the substances are applied by filling the external auditory canal with lidocaine or distilled water for 5 min. Tinnitus intensity is measured (acuphenometry and VAS) before and after substance application and the variation is compared between lidocaine and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double blind study. The substances are produced by the same handling pharmacy and delivered in identical vials, only with the information: substance 1 and substance 2.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months
排除标准
- •Otological infection
- •Tympanic membrane perforation
- •Anatomical alteration of the external ear
- •Pulsatile tinnitus
- •Objective tinnitus
- •Known allergy to lidocaine or other topical anesthetic and pregnancy
研究组 & 干预措施
Lidocaine 10%
The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and 10% lidocaine is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).
干预措施: Lidocaine 10 MG/ML (Drug)
Placebo
The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and distilled water is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).
干预措施: Distilled water (Drug)
结局指标
主要结局
Change in Visual Analogue Scale (VAS) Score
时间窗: Immediately before and 5 minutes after receiving intervention on days 1 and 15
scale ranging from 0 to 10 points used to measure the intensity of tinnitus, where zero corresponds to the absence of tinnitus perception and 10 corresponds to the largest volume that the patient imagines that tinnitus may have.
Change in Tinnitus Loudness
时间窗: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure tinnitus intensity. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the tinnitus loudness is defined. Tinnitus loudness is measured in decibels and the higher the value found, the louder the tinnitus intensity.
Change in Minimum Masking Level (MML)
时间窗: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure minimum masking level. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the minimum stimulus that masks tinnitus is determined. The minimum masking level is the intensity that an external sound must have to cover up tinnitus until it is no longer perceived by the patient. MML is measured in decibels. The lower the MML value, the more easily tinnitus can be masked, suggesting a lower degree of discomfort for the patient.
次要结局
未报告次要终点
研究者
Ricardo Ferreira Bento, PhD
Professor of Otorhinolaringology Department of Faculdade de Medicina da Universidade de São Paulo
University of Sao Paulo General Hospital