Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Vertigo; Ear Infection; Hearing Loss

Treatments: Drug: drops intilation (Placebo); Drug: drops intilation (Taponoto ® ); Drug: drops intilation (Otocerum®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00765635

CLO2008/4503

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of ear cerumen

Exclusion criteria

• Infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

2

Experimental group

Description:

Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),

Treatment:

Drug: drops intilation (Taponoto ® )

3

Placebo Comparator group

Description:

sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).

Treatment:

Drug: drops intilation (Placebo)

1: Chlorobutanol

Experimental group

Description:

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),

Treatment:

Drug: drops intilation (Otocerum®)