Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Study Overview
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Brief Summary
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Accumulation of cerumen in the external ear canal is a common problem. The presence of cerumen not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections. Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents. The current study was designed to evaluate the ceruminolytic effects of a single, brief application of the two most frequently used products in the investigators area, containing chlorobutanol or potassium carbonate with or without irrigation in the primary care setting in a randomized, single-blind trial. To our knowledge, this is the first randomized study comparing ceruminolytics with chlorobutanol versus potassium carbonate.

Detailed Description
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INTERVENTIONS: Subjects were randomly assigned to one of three different treatments: Otocerum®; Taponoto ®, and a control group with sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain). The test medication was instilled into an occluded ear for 15 minutes. Following this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed.

Official Title
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Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Conditions
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Ear Infection, Hearing Loss, Vertigo

Intervention / Treatment
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* Drug: drops intilation (Taponoto ® )
* Drug: drops intilation (Otocerum®)
* Drug: drops intilation (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ear cerumen Exclusion Criteria: Infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain), | Drug: drops intilation (Taponoto ® )<br>* four drops, unique doses<br>|
| Placebo Comparator: 3<br>sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain). | Drug: drops intilation (Placebo)<br>* Placebo<br>|
| Experimental: 1: Chlorobutanol<br>ceruminolytic product, Otocerum® (Chlorobutanol 50 mg/1 ml, phenol 10 mg/1 ml, turpentine essence 0.15 ml/1 ml, ethyl alcohol; Reig Jofre laboratories, Barcelona, Spain), | Drug: drops intilation (Otocerum®)<br>* four drops, unique doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed |  | 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects |  | 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complete occlusion of the ear canal due to cerumen