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QUESTION: Is a single brief application of docusate sodium (Colace), with or without irrigation, more effective than triethanolamine polypeptide (Cerumenex), with or without irrigation, for clearing cerumen (earwax) in patients presenting to the emergency department?
Randomised (allocation not concealed), blinded (unclear) controlled trial.
The emergency department of a tertiary care centre in Stony Brook, New York, USA.
50 patients who were ≥1 year of age (mean age 40 y, 65% men), had a medical condition that required visualisation of the ear canal (eg, earache, hearing loss, or fever), and had cerumen partially or totally occluding the ear canal. Patients were excluded if they had known or suspected tympanic membrane perforation, overt ear infection, were uncooperative, or were allergic to either of the solvent agents. Follow up was complete.
27 patients were allocated to docusate sodium, and 23 were allocated to triethanolamine polypeptide. A physician applied 1 ml of the solvent agent to the affected ear and instructed the patient to lie on his side with the affected ear facing upward for 10–15 minutes. The solution was allowed to drain, and any remains were absorbed with a cotton tipped swab. If the tympanic membrane could still not be completely visualised, the physician irrigated the external ear canal with 50 ml of lukewarm saline solution. If the tympanic membrane was still not completely visible, the external ear canal was irrigated a second time.
Main outcome measures
Main outcome was complete visualisation of the tympanic membrane after application of the solvent agent, with or without irrigation. A secondary outcome was presence of any adverse events.
No group differences existed for complete visualisation of the tympanic membrane after the application of the solvent agent alone. However, after combining the results for those who did and did not receive irrigation after application of the solvent agent, the tympanic membrane could be completely visualised in more patients who received docusate sodium than in those who received triethanolamine polypeptide (table⇓). No adverse events occurred in either group.
A single application of docusate sodium followed by irrigation was more effective than triethanolamine polypeptide with irrigation for dissolving cerumen and allowing complete visualisation of the tympanic membrane in patients who presented to the emergency department.
It is common for cerumen to accumulate in the external ear canal. Cerumen can cause hearing loss, vertigo, infection, and can interfere with the clinician's view of the tympanic membrane. Use of manual instruments or syringe irrigation to remove cerumen causes discomfort and could cause injury to the auditory canal and tympanic membrane. Singer et al examined the effectiveness of 2 ceruminolytic agents, which are less invasive and cause less patient discomfort than instruments or syringe irrigation.
The study question was appropriately addressed using a randomised controlled design. The sample size of 50 was based on 80% power to detect a large difference between groups of 40%; this probably resulted in the lack of statistical significance between groups with the use of the solvent alone, although the tympanic membrane was completely visualised in 19% of patients who received docusate sodium and only 9% of patients who received triethanolamine polypeptide. This study should be repeated with a larger sample size. However, when the authors combined the groups who did and who did not receive irrigation after solvent administration, their findings indicated that 3 patients would need to be treated with docusate sodium likely followed by irrigation to achieve 1 additional complete visualisation of a tympanic membrane (see NNT in table).
A potential for bias exists in this study because the solutions differed in colour and therefore it would be difficult for the physicians who were both administering the solvent and visualising the tympanic membrane to remain blinded to which solvent each patient received. Additionally, the inclusion of a control group that had only water instilled followed by irrigation would have helped to determine the effect of irrigation alone.
Although physicians applied the solvent in this study, ceruminolytics are also commonly given by nurses. The findings of this study have relevance for nurses working in accident and emergency settings, but may be even more relevant to those working in ear, nose, and throat, and general practice settings, who may have more opportunity to use ceruminolytics.
Source of funding: not stated.
For correspondence: Dr A J Singer, Department of Emergency Medicine, University Medical Center, L4-515, Stony Brook, NY 11794-7400, USA. Fax +1 631 444 6233.