TEOVISIO, JESSELY B.

BSN117

EVIDENCE-BASED NURSING
ABOUT DOCUSATE SODIUM WITH IRRIGATION FOR DISSOLVING EARWAX

I. CLINICAL 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?

I. CITATION
Docusate sodium with irrigation was better than triethanolamine polypeptide with irrigation for dissolving
earwax
(2000) Ann Emerg Med 36, 228. Singer AJ, Sauris E, Viccellio AW.. Ceruminolytic effects of docusate sodium: a
randomized, controlled trial.. Sep;. :. –32.

II. STUDY CHARACTERISTICS

1. Patient’s Included
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.

2. Interventions Compared
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.

3. Outcomes Monitored
Main outcome was complete visualization of the tympanic membrane after application of the
solvent agent, with or without irrigation. A secondary outcome was presence of any adverse events. The
adverse events subjectively reported by patients were also recorded.

4. Does the study focus on a significant problem in clinical practice?

Yes.

III. METHODOLOGY/DESIGN

1. Methodology Used
The study was a randomized double-blind trial.

2. Design
A physician determined tympanic membrane obstruction. The authors reported an interobserver
reliability of 79%, but the method of determination was not discussed. A 1-mL dose of either
triethanolamine or docusate was placed in the affected ear canal and allowed to remain for 10 to 15
 minutes. In an attempt to mask the treatments, doses were placed in opaque syringes to obscure the
color difference. If the wax was not removed, the ear was irrigated once or twice with 50 mL normal
saline.

3. Setting
The emergency department of a tertiary care centre in Stony Brook, New York, USA.

4. Subject Selection
Patients were excluded for known or suspected perforation, overt ear infection, or lack of cooperation.
The wide age range probably would not affect study results, because age does not affect cerumen
quantity or quality.

5. Has the original study has been replicated?

No.

6. What were the risks and benefits of the nursing action/intervention tested in the study?
Overall the study has few faults. One concern is that a convenience sample of patients was used, and
allocation may not have been concealed. As a result, the researchers could have chosen either
particularly difficult or minor cerumen obstructions when enrolling patients in the study.

IV. RESULTS OF THE STUDY

 Immediately after ceruminolytic instillation there was no difference between the 2 treatments. However,
after 2 irrigations with normal saline, complete clearing was achieved in 82% of the docusate-treated
patients and 35% of the triethanolamine-treated patients (difference = 47%; 95% confidence interval [CI],
22%-71%). In other words, every other patient treated with docusate instead of triethanolamine would have
benefited (number needed to treat = 2.13). Although this difference was markedly greater in children
younger than 5 years (difference = 90; 95% CI, 51%-100%), there were only 4 very young children who
received triethanolamine. No adverse events were reported.

No group differences existed for complete visualization 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 visualized in
more patients who received docusate sodium than in those who received triethanolamine polypeptide. No
adverse events occurred in either group.

V. AUTHOR’S CONCLUSION/RECOMMENDATIONS

Conclusion
A single application of docusate sodium followed by irrigation was more effective than triethanolamine
polypeptide with irrigation for dissolving cerumen and allowing complete visualization of the tympanic
membrane in patients who presented to the emergency department.

Commentary
AMANDA ROBINSON, RGN, MSc
Sister/Emergency Nurse Practitioner Dryburn Hospital, Durham City, UK

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 alexamined 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.

VI. APPLICABILITY

1. Does the study provide a direct enough answers to your clinical question in terms of type of patients,
intervention and outcome?
Yes, the study showed in the interventions done that docusate sodium is better than the triethanolamine
peptide in removing acute earwax.

2. Is it feasible to carry out the nursing action in the real world?

The intervention is feasible to carry out since it is easy to induce and it is safe.

VII. REVIEWER’S CONCLUSION/COMMENTARY

Options for removing cerumen include the use of a ceruminolytic, a curette, irrigation, or a combination.
Irrigation and mechanical extraction carry the risk of patient discomfort, ossicle disruption, trauma, and
infection. Ceruminolytics used in practice include water, sodium bicarbonate, hydrogen or carbamide
peroxide, mineral or olive oil, glycerin, triethanolamine oleate, and propylene glycol. Although docusate has
been used empirically, only in vitro data are available to support its use.

Docusate is superior to triethanolamine polypeptide for acute earwax removal, especially in children
younger than 5 years. This study was not designed to evaluate the efficacy of ceruminolytics on a chronic
basis. Generic docusate liquid is less expensive than triethanolamine polypeptide. Clinicians should use the
liquid formulation, not the syrup.