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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
four drops, unique doses
four drops, unique doses
Placebo
Hospital Clinic
Barcelona, barcelona, Spain
proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed
Time frame: 2008
adverse effects
Time frame: 2008
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.