When we think of lysing things in the emergency department (ED), we think of alteplase busting up a blood clot in either ischemic stroke or in patients experiencing a massive pulmonary embolism. Another lytic that is used in the ED is docusate for cerumen impaction. That’s right – docusate – which is usually thought of as a stool softener, may be used as a cerumenolytic.
Cerumen, a.k.a. earwax, is a substance that cleans, protects, and lubricates the external auditory canal and is formed when glandular secretions from the outer two-thirds of the ear canal mix with exfoliated squamous epithelium. Cerumen is composed of secretions and sloughed epithelial cells, and as it migrates laterally, may mix with hair and other particulate matter. It is normally naturally extruded by a self-cleaning mechanism that causes it to migrate out of the ear canal assisted by jaw movement; however, a failure of this mechanism may lead to accumulation and occlusion in one or both ears. Ultimately, this may cause discomfort, hearing loss, tinnitus, dizziness, ear fullness, itching, otalgia, discharge, odor, chronic cough, and contribute to otitis externa.
According to the American Academy of Otolaryngology-Head and Neck Surgery guideline on earwax, cerumen impaction is defined as an accumulation of cerumen that causes symptoms or inhibits the assessment of the ear canal, tympanic membrane, audiovestibular system, or both. Accumulation of cerumen is a common problem and is present in 1 in 10 children, 1 in 20 adults, and more than one-third of the geriatric and developmentally delayed populations. Annually, approximately 12 million people in the United States seek care for problematic cerumen, resulting in nearly 8 million cerumen removal procedures.
Docusate – the lytic we didn’t know we needed
There are multiple treatment options for cerumen impaction which include observation, cerumenolytics, irrigation, manual removal other than irrigation, and a combination thereof (e.g., cerumenolytic plus irrigation). Cerumenolytics are used to disperse the cerumen and reduce the need for syringing or for manual removal. They are topical compounds that disintegrate earwax and exist in 3 forms: water-based, oil-based, and non-water/non-oil-based. Docusate is a water-based cerumenolytic and exerts its effects by inducing hydration and subsequent fragmentation of corneocytes within the cerumen.
A prospective, randomized, double-blind, controlled trial by Singer and colleagues, evaluated the cerumenolytic effects of docusate, with or without irrigation, compared to triethanolamine polypeptide. Patients included were those greater than 1 year of age, their medical condition required visualization of the ear canal, and their ear canal was partially or totally occluded by cerumen. Criteria for exclusion included suspected or known tympanic membrane perforation, overt infection of the ear, uncooperative patients, or known allergies to any of the solvent agents. Patients received either 1 mL of docusate sodium or 1 mL of triethanolamine polypeptide in the affected ear and were instructed to lie on their side with the affected ear facing upward for 10 to 15 minutes. There were 50 patients in the study, 27 in the docusate group and 23 in the triethanolamine polypeptide group. After installation of the cerumenolytic, with or without irrigation with normal saline, 82% versus 35% of patients were able to have their tympanic membrane completely visualized in the docusate and triethanolamine polypeptide group, respectively. No adverse events were reported.
Another study by Whatley et al compared docusate, triethanolamine polypeptide, and normal saline as a control, with or without irrigation, in removing cerumen in children in the emergency and outpatient setting. Patients received 1 mL of one of the treatment options in the affected ear and parents of the patient were asked to keep their child lying flat with their ear facing upward for 15 minutes. There were 92 patients included in the final analysis – 34, 30, and 28 in the docusate, triethanolamine, and normal saline groups, respectively. There was no significant difference in complete visualization of the tympanic membrane with an agent. One patient experienced ear canal bleeding and no other adverse events were reported.
In a study by Meyer et al, they looked to assess the effectiveness of no pre-treatment compared to pre-treatment with different preparations to aid in the removal of earwax in adults and children with one of the preparations being docusate. There were 168 patients in the study with 47 of these patients (69 total ears) receiving docusate. There was complete clearance in 83% of the docusate group compared to 64% clearance in the no preparation group, 66% in the water-based group, and 68% in the oil-based group. The odds ratio in the docusate-based group was 1.87 (95% CI: 0.79 – 4.42) indicating higher effectiveness, although not statistically significant. There was also a slight trend toward higher effectiveness for any pre-treatment compared to no pre-treatment.
Cerumenolytics should be avoided in patients with a suspected breach of the tympanic membrane resulting from surgery, insertion of myringotomy tubes, or tympanic membrane perforation. Complications associated with the treatment of cerumen impaction include tympanic membrane perforation, ear canal laceration, infection of the ear, bleeding, or hearing loss, and occur at a rate of 1 in 1000 ear irrigations. The use of cerumenolytics may improve irrigation success by as much as 97%. The most recent review by Horton and colleagues recommends docusate as a second-line cerumenolytic when water or saline are ineffective.
How to use
In the studies mentioned above, 1 mL of docusate was used as a cerumenolytic and was administered in the affected ear with the patient lying down on their side with the affected ear facing upward for at least 10 – 15 minutes. If the tympanic membrane was not completely visualized after administration of the medication, irrigation with 50 – 100 mL of lukewarm normal saline may be completed.
- Docusate is a stool softener that may be used as a cerumenolytic for patients with cerumen impaction.
- The current evidence is weak for its use for this indication; however, studies indicate a higher trend toward complete visualization of the tympanic membrane when docusate is used.
- Docusate should be administered as 1 mL in the affected ear and left to sit in the ear for 10 – 15 minutes prior to assessing the patient. This may be followed by irrigation if clearance is not obtained.
- Docusate is a suitable agent for the use as a cerumenolytic in patients presenting with cerumen impaction.
- McCarter D, Courtney U, Pollart S. Cerumen Impaction. Am Fam Physician. 2007; 75: 1523 – 28.
- Schwartz S, Magit A, Rosenfeld R, et. al. Clinical Practice Guideline (Update): Earwax (Cerumen Impaction). Otolaryngol Head Neck Surg. 2017; 156(1_suppl): S1 – S29.
- Singer A, Sauris E, Vicellio A. Ceruminolytic effects of docusate sodium: a randomized, controlled trial. Ann Emerg Med. 2000; 36(3): 228 – 32.
- Whatley V, Dodds C, Paul R. Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children. Arch Pediatr Adolesc Med. 2003;157(12): 1177-80.
- Meyer F, PreuB R, Angelow A, et. al. Cerumen Impaction Removal in General Practices: A Comparison of Approved Standard Products. J Prim Care Community Health. 2020; 11: 1 – 5.
- Hand C, Harvey I. The effectiveness of topical preparations for the treatment of earwax: a systematic review. Br J Gen Pract. 2004; 54(508): 862 – 7.
- Horton G, Simpson M, Beyea M, Beyea J. Cerumen Management: An Updated Clinical Review and Evidence-Based Approach for Primary Care Physicians. J Prim Care Community Health. 2020; 11: 1 – 5.