Original ContributionsCeruminolytic Effects of Docusate Sodium: A Randomized, Controlled Trial*
Introduction
Accumulation of cerumen in the external ear canal is a common problem.1 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, as well as contribute to infection. Evacuation of cerumen may be performed by manual instrumentation or frequent copious syringe irrigation. However, both of these procedures are uncomfortable and may result in injury to the external ear canal and the tympanic membrane.2, 3 There have even been rare deaths associated with syringe irrigation.4 Removal of cerumen is facilitated by the use of a variety of ceruminolytics or wax solvents. Several studies have evaluated the ceruminolytic effects of a wide range of solvents such as olive oil, sodium bicarbonate, distilled water, glycerine, acetone, triethanolamine polypeptide, hydrogen peroxide, dichlorobenzene, and various forms of docusate sodium.5, 6, 7, 8, 9, 10 However, many of these studies were conducted in vitro, lacked adequate controls or formal statistical analysis, or were conducted in the outpatient setting where patients were instructed to apply the solvent over the course of several days.
The current study was designed to evaluate the ceruminolytic effects of a single brief application of docusate sodium with or without irrigation in the emergency setting and to compare these effects with those of a commonly prescribed ceruminolytic, triethanolamine polypeptide, in a randomized, double-blind fashion.
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Methods
A prospective, randomized, double-blind controlled trial design was used to compare the ceruminolytic effects of docusate sodium solution and triethanolamine polypeptide drops. This project was approved by the institutional review board.
The trial was conducted on a convenience sample of patients who presented to the emergency department of the State University of New York at Stony Brook, a tertiary care center with an annual census of 55,000. Patients were eligible for enrollment if they were 1
Results
Fifty eligible patients were enrolled during the study period. Their mean age (±SD) was 40±18 years (range 1 to 18 years), and 35% were female. Thirteen (26%) patients were children aged 5 or younger. Of all patients, 23 were randomly assigned to receive triethanolamine polypeptide and 27 received docusate sodium. Comparison of baseline characteristics indicated that groups were similar in age, sex, and the proportion of initially completely obscured tympanic membranes (Table 1).
Discussion
Docusate sodium is a commonly prescribed stool softener. Its surfactant properties also make it an effective agent for dissolving earwax. Although prescribed in the United Kingdom, the ceruminolytic effects of docusate sodium are less widely known in the United States. Several in vitro studies have concluded that of all agents tested, docusate sodium is one of the most effective wax solvents.5, 8 In 1965, the General Practitioner Research Group first reported that an oil-based docusate sodium
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A comparative in vitro study on the cerumenolytic effect of docusate sodium versus 2.5% sodium bicarbonate using UV–visible absorption spectroscopy
2020, Journal of OtologyCitation Excerpt :Therefore, the superior efficacy of cerumenolytic agents still is controversy. Furthermore, several previous studies (Bellini et al., 1989; Singer et al., 2000; Bruton and Doree, 2009) have investigated the efficacy of cerumenolytic agents using subjective assessment of the results. Thus, we developed a more objective and quantitative approach using UV–visible absorption spectroscopy.
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2008, Otolaryngology - Head and Neck SurgeryCitation Excerpt :One exception is a study of emergency room patients age 1 to 81 who presented with suspected ear problems and in whom visualization of the tympanic membranes was partially or totally obscured by cerumen. After instillation of docusate sodium followed by irrigation if necessary, there was full visualization 81% of the time.47 Statement 3b.
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Address for reprints: Adam J. Singer, MD, Department of Emergency Medicine, University Medical Center, L4-515, Stony Brook, NY 11794-7400; 631-444-7856, fax 631-444-3919; E-mail [email protected].