Elsevier

Annals of Emergency Medicine

Volume 36, Issue 3, September 2000, Pages 228-232
Annals of Emergency Medicine

Original Contributions
Ceruminolytic Effects of Docusate Sodium: A Randomized, Controlled Trial*

https://doi.org/10.1067/mem.2000.109166Get rights and content

Abstract

Study Objective: Assessment of the tympanic membrane is often impeded by the presence of cerumen. We compared the ceruminolytic effects of triethanolamine polypeptide and docusate sodium in patients with cerumen. Methods: We conducted a prospective, randomized, controlled, double-blind trial on a convenience sample of cooperative adult and pediatric patients presenting to a university-based emergency department who required removal of cerumen to visualize the tympanic membrane. Structured data collection was performed, and the physician determined whether visualization of the tympanic membrane was partially or totally obscured by cerumen (interobserver agreement, ρ=0.79). Patients received intra-aural instillation of 1mL of either docusate sodium or triethanolamine polypeptide in a liquid form. If not completely cleared within 15 minutes, the external ear canal was irrigated with 50 or 100 mL of normal saline solution and additional attempts to visualize the tympanic membrane were made. The main outcome was the proportion of ears in which the tympanic membrane could be totally visualized after ceruminolytic instillation with or without irrigation. This study had 80% power to detect a 40% difference between groups in the proportion of totally visualized tympanic membranes (χ2 test, α=.05). Results: Of 50 enrolled patients, 23 received triethanolamine polypeptide and 27 received docusate sodium. Mean patient age was 40 years (range 1 to 81 years); 35% were female. Groups were similar in age, sex, and proportion of completely obscured tympanic membranes at presentation (78%). The ability to completely visualize the tympanic membrane was significantly greater after treatment with docusate sodium versus triethanolamine polypeptide (81% versus 35%; difference in proportions 47%; 95% confidence interval [CI], 22 to 71) particularly in children aged 5 or less (90% versus 0%; difference in proportions 89%; 95% CI 50 to 100). Conclusion: Docusate sodium solution is a more effective ceruminolytic than triethanolamine polypeptide, allowing complete or partial visualization of the tympanic membrane in most patients after a single application when followed with irrigation. Use of docusate sodium as a ceruminolytic should be encouraged, particularly in children. [Singer AJ, Sauris E, Viccellio AW. Ceruminolytic effects of docusate sodium: a randomized, controlled trial. Ann Emerg Med. September 2000;36:228-232.]

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.

Section snippets

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).

. Baseline

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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*

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].

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