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临床试验/NCT04794842
NCT04794842进行中(未招募)早期 1 期

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

Our Lady of the Lake Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
Difference in Pain Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Intervention choice blinded to the patient

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Tetracaine

Active Comparator

Patients 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.

干预措施: Tetracaine 5% drops (Drug)

Phenol

Active Comparator

Patients 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).

干预措施: Phenol 90% concentration (Drug)

结局指标

主要结局

Difference in Pain Score

时间窗: Immediately following the procedure to 6 months from procedure

Evaluate any differences in pain scores assessed pre/post intervention and between the two topical anesthetics used prior to the intratympanic steroid injection

次要结局

  • Statistical difference in tympanic membrane perforation presence or absence after the steroid injection procedure when using either tetracaine or phenol as the local anesthetic(Immediately following the procedure to 6 months from procedure)

研究者

发起方
Our Lady of the Lake Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leslie Son

Academic Research Director

Our Lady of the Lake Hospital

研究点 (1)

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