CERUMINOLYTIC
EFFECTS OF DOCUSATE SODIUM: A RANDOMIZED, CONTROLLED TRIAL.
Singer
AJ, Sauris E, Viccellio AW. Ann Emerg Med 2000 Sep;36(3):228-32.
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, rho=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 (chi(2) test,
alpha=.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.