How does liquid docusate sodium compare with triethanolamine polypeptide as a
ceruminolytic for acute earwax removal? - Colace
Journal of Family Practice, Dec, 2000 by Emily Masterson, Terry L. Seaton
Singer AJ, Sauris E, Viccellio AW. Ceruminolytic effects of docusate sodium: a randomized, controlled trial. Ann
Emerg Med 2000; 36:228-32.
*
BACKGROUND 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. The authors of this study evaluated the
comparative efficacy of docusate and triethanolamine polypeptide for acute earwax removal.
* POPULATION STUDIED Fifty adult and pediatric patients from a university-based emergency department were
enrolled on a convenience basis. The participants were older than 1 year, had a medical condition requiring
tympanic membrane visualization, and had partially or totally obscured tympanic membranes. The sample
subjects were 35% female and 26% very young ([is less than] 5 years). Patients were excluded for known or
suspected perforation, overt ear infection, or lack of cooperation.
* STUDY DESIGN AND VALIDITY The study was a randomized double-blind trial. 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.
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. The wide age range probably would not affect study
results, because age does not affect cerumen quantity or quality.
* OUTCOMES MEASURED The main outcome measure was the percentage of tympanic membranes totally
visualized with or without saline irrigation. The adverse events subjectively reported by patients were also
recorded.
* RESULTS 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.
RECOMMENDATIONS FOR CLINICAL PRACTICE
Docusate is superior to triethanolamine polypeptide for acute earwax removal in the office, 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. One pint (480 doses) costs
approximately $7.00 compared with $2.50 for 15 mL of generic triethanolamine polypeptide. Clinicians should use
the liquid formulation, not the syrup.
ข้ อมูลจากhttp://articles.findarticles.com/p/articles/mi_m0689/is_12_49/ai_68913010
1: Cochrane Database Syst Rev. 2003;(3):CD004400.
Related Articles, Links
Ear drops for the removal of ear wax.
Burton MJ, Doree CJ.
Department of Otolaryngology - Head and Neck Surgery, Radcliffe Infirmary, Woodstock
Road, Oxford, UK, OX2 6HE.
BACKGROUND: Problems attributed to the accumulation of wax (cerumen) are one of the
most common reasons for people to present to their general practitioners with ear trouble
(Sharp 1990). Treatment for this condition often involves use of a wax softening agent
(cerumenolytic) in order to disperse the cerumen and reduce the need for syringing, or to
facilitate syringing should it prove necessary, but there is no consensus on the effectiveness
of the wide variety of cerumenolytics in use. OBJECTIVES: To assess the effectiveness of
ear drops (cerumenolytics) for the removal of symptomatic ear wax. SEARCH STRATEGY:
We searched the Cochrane ENT Group Register, the Cochrane Central Register of Controlled
Trials (CENTRAL, Issue 1, 2003), and MEDLINE and EMBASE up to March 2003.
Reference lists of all trials were also manually searched. SELECTION CRITERIA: We
identified all randomised controlled trials (with or without blinding) in which a
cerumenolytic was evaluated in comparison with either no treatment, a placebo, or other
cerumenolytics in participants with hard or impacted ear wax, and in which the proportion of
participants with sufficient clearance of the external canal to make further mechanical
clearance unnecessary (primary outcome measure) was stated or calculable. The full text
articles of all the retrieved trials of possible relevance were reviewed by the two reviewers
and the inclusion criteria applied independently. Any differences in opinion about which
studies to include in the review were resolved by discussion. DATA COLLECTION AND
ANALYSIS: Trials were graded for methodological quality using the Cochrane approach.
Data extraction was performed in a standardised manner by one reviewer and rechecked by
the other reviewer, and where necessary investigators were contacted to obtain missing
information. Meta-analysis was neither possible nor considered appropriate because of the
heterogeneity of the treatments, treatment amounts and durations, trial procedures, and
scoring systems. A narrative overview of the results is therefore presented. MAIN
RESULTS: Eight trials satisfied the inclusion criteria, the majority of which were of poor
quality. In all, 587 participants received one of nine different cerumenolytics. One trial
compared active treatments with no treatment, two trials compared active treatments with
water or a saline 'placebo', and all eight trials placed two or more active treatments in headto-head comparisons. Seven trials included syringing as a secondary treatment where
necessary.Overall, results were inconclusive. One trial found a significant difference between
one of three active agents (Cerumol) in comparison to no treatment, but no statistically
significant difference was found between these three agents (sodium bicarbonate ear drops;
Cerumol; sterile water). In two trials no statistical difference was found between the
effectiveness of either sodium bicarbonate ear drops, Cerumol, Cerumenex or Colace versus
a sterile water or saline 'placebo'. Three trials (from the same source) found statistically
significant differences in favour of the same active agent (Exterol) in comparison to glycerol
and Cerumol. Three trials found no statistically significant difference between two or more
cerumenolytics (Otocerol versus Cerumol; Audax versus Earex; sodium bicarbonate ear
drops versus Cerumol). Two trials comparing the same two cerumenolytics (Cerumenex
versus Colace) also failed to show any significant benefit of one over the other. No serious
adverse effects were reported from any of the interventions. REVIEWER'S
CONCLUSIONS: Trials to date have been heterogeneous and of poor quality, making it
difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for
the removal of symptomatic ear wax. Future trials should be of high methodological quality,
have large sample sizes, and compare both oil-based and water-based solvents with placebo
and/or no treatment.
ข้ อมูลจาก
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12918014&dopt=Abstract
Patient Group Directive for the administration of almond oil eardrops and
sodium bicarbonate eardrops
Nurses are called upon by patients, and by GPs referring patients, to syringe ears. This
directive allows the nurse to supply softening agents, either as an alternative to syringing,
or when softening with warm water has proved ineffective.
1. Clinical Situation
Clinical situations
Symptoms and signs of deafness caused
by excessive ear wax
Criteria for inclusion
Patients over the age of 12 with deafness
attributable to excessive earwax.
Criteria for exclusion


Reasons for seeking
further advice from
doctor/dentist
Patients under the age of 12 are
excluded.
Patients who decline treatment from
the nurse are excluded.
 Patient under the age of
12
 History of perforation of









eardrum
History of recurrent otitis
externa
History of previous ear
surgery
Pre-existing severe
hearing loss in one ear,
wax in the ‘good’ ear
Pain and/or itching in ears
Discharge or bleeding
from ears
No wax visible on initial
examination
Presence of pus or blood
visible in ear canal
Difficulty syringing ears
Deafness persisting after
successful removal of
earwax.
Action if excluded
 Patients excluded from
this directive should be
offered a GP appointment.
 Patients complaining of
pain should be discussed
with the duty doctor.
Action if consent withheld
Patients declining treatment
under this directive should be
offered a GP appointment.
Record that consent was
withheld.
2. Characteristics of staff authorised to practice under the
Patient Group Directive.
These notes should be read in conjunction with the main
page about the law and nurses duties, which is filed at the
front of the Patient Group Directive folder.
Class of health professional
Practice nurses employed by
the practice at grade ‘F’ or
above. Individual nurses are
named at appendix 1
Additional requirements
Staff must have received
training on the correct use of
ear syringing equipment.
Staff must have read the
protocol on ear syringing.
Continued training requirements
None
3. Details of medicines to be administered under Patient
Group Directive
Name of Medicine
Almond oil ear drops
Legal Classification (POM/P/GSL)
GSL
Black Triangle Drug?
No
Outside terms of SPC?
No
Dose
3 drops to affected ear twice daily for 3
days
Route/Method of
administration
Aurally
Frequency
3 drops to affected ear twice daily for 3
days
Period of administration
Min. period of administration:
3 days
Max.
Period
of
administration: 5 days
Restrictions on quantity to be
supplied on one occasion
25ml
How supplied
Supplied in manufacturer’s bottle 25ml
with dropper.
Labelled by practice dispensing software:
see appendix 2
Warnings
Contraindications: Allergy to
nuts/almonds
If patient develops a local
rash suggestive of an allergic
response, the eardrops
should be discontinued and
the patient should be offered
an appointment with a GP or
discussed with the duty
doctor.
Patient/Carer Information
The
patient
should
be
advised to lie with the
affected ear uppermost for 5
to
10
minutes
after
introduction of 3 drops of the
softening agent.
Patient should be given an
appointment with the nurse
for review after 3 days of
treatment.
If the patient is allergic to almond oil, the nurse may supply Sodium bicarbonate eardrops
instead.
Name of Medicine
Sodium
drops
Bicarbonate
ear
Legal Classification (POM/P/GSL)
Black Triangle Drug?
No
Outside terms of SPC?
No
Dose
3 drops to affected ear twice daily for 3
days
Route/Method of
administration
Aurally
Frequency
3 drops to affected ear twice daily for 3
days
Period of administration
Min. period of administration:
3 days
Max.
period
of
administration: 5 days
Restrictions on quantity to be
supplied on one occasion
10ml
How supplied
Supplied in manufacturer’s bottle 10ml
with dropper.
Labelled by practice dispensing software:
see appendix 2
Warnings
Contraindications: Perforated tympanic
membrane
Adverse effects: Local irritation
If the eardrops cause
irritation, the patient should
be advised to discontinue the
eardrops. They should be
discussed with the duty
doctor, or reviewed by the
nurse on duty.
Patient/Carer Information
The
patient
should
be
advised to lie with the
affected ear uppermost for 5
to
10
minutes
after
introduction of 3 drops of the
softening agent.
Patient should be given an
appointment with the nurse
for review after 3 days of
treatment.
4. Documentation
Follow up
Patients will be given a follow
up appointment with the
nurse.
Documentation
Records will be kept
according to the step-by-step
guide at appendix 3
Preparation details:
Author & job title
Dr S K Dawson GP Principal
Signature
5. Review and Authorisation
This patient group Directive has been approved for use by the signatories below:
Pharmacist
……………………………….
(name)
……………………………….
(signature)
……………………………….
(date)
GP partners
……………………………….
(name)
……………………………….
(name)
……………………………….
(signature)
……………………………….
(signature)
……………………………….
(date)
……………………………….
(date)
……………………………….
(name)
……………………………….
(name)
……………………………….
(signature)
……………………………….
(signature)
……………………………….
(date)
……………………………….
(date)
Medical Director/ Clinical
lead
……………………………….
(name)
……………………………….
(signature)
……………………………….
(date)
Please forward a copy of this PGD to the ADTC
Date effective……………………………………………..
Review date……………………………………………… should make
it clear that after this date the PGD is not valid
The practice is responsible for auditing the use of this
document within their own audit program.
Appendix 1
Health professionals approved to provide care under the
Directive
Name
Signatu Date
re
Angela
Binnie
Barbara
MacAul
ay
Isabel
MacInn
es
Peigi
MacLea
n
Morag
MacSw
een
Approved
by:
Dr S K
Dawson
Name
Date
Dr S K
Dawson
Dr S K
Dawson
Dr S K
Dawson
Dr S K
Dawson
Appendix 2:
Affix samples of labels to be used.
Appendix 3: See attached step-by-step guidance
Appendix 4: See attached protocol for ear syringing.
Reference 1: A quasi-randomised controlled trial of water as a quick softening
agent of persistent earwax in general practice
J A H Eekhof, G H de Bock, S Le Cessie and M P Springer
British journal of general practice August 2001
PROTOCOL FOR EAR SYRINGING
AIMS
To remove wax from ears with as little discomfort
as possible to the patient.
NURSES ROLE
Nurses will syringe ears when requested by the
doctor or patient self refers to the nurse because
of deafness. There is a protocol for the removal
and softening of wax using softening agents.
Before the nurse undertakes the task of syringing
ears, she must be shown the proper procedure,
i.e.:
1.
2.
3.
How to examine the ear with an auroscope, pulling the pinna
down slightly for children and upwards and outwards for
adults.
How to use the ear syringe or the electric machine, making
sure the nozzle is not inserted beyond the entrance to the
canal.
The water used for syringing must be at body temperature.
When not to syringe ears:
Patient under the age of 12
2. History of perforation of eardrum
3. History of recurrent otitis externa
4. History of previous ear surgery
5. Pre-existing severe hearing loss in one ear, wax in the ‘good’
ear
6. Pain and/or itching in ears
7. Discharge or bleeding from ears
8. No wax visible on initial examination
9. Presence of pus or blood visible in ear canal
10. Difficulty syringing ears
1.
Patient’s self-referral.
When a patient self refers to the nurse, complaining of deafness,
she should examine the ears to exclude any abnormalities other
than wax. Before proceeding with syringing the ears, the wax
should be softened with a little warm water for 15 minutes.
Refer to the doctor if:
1.
2.
Syringing is contra-indicated as above or
Deafness persisting after successful ear syringing
Equipment:
1.
2.
3.
4.
Electric machine or metal ear syringe
Protective plastic disposable apron.
Paper Towel.
Gauze swabs for drying the ear.
If the wax persists after syringing, patient should be advised to
insert oil into the ears twice a day for 3-4 days and an
appointment given to return for syringing. There is a group
patient directive covering the supply of softening agents.
EARWAX: STEP–BY-STEP MANAGEMENT BY NURSING STAFF
STEP 1: SYMPTOMS
Does the patient have any symptoms indicative of excessive earwax? (Hearing loss, previous similar
episodes, no dizziness, no pain, and no pus). There should be no past history of: perforation of
eardrum, recurrent otitis externa, ear surgery, or unilateral deafness. The patient should be over 12.
1. If the answer is YES to all of the criteria, then the patient may have excessive
earwax suitable for either treatment with a softening agent or for syringing. Proceed
to the next step.
2. If the answer is NO to any of the above criteria, then the directive does not apply,
and the patient should be offered a GP appointment and/or discussed with the duty
doctor. The directive concerning otitis media may apply.
Record symptoms in the patient’s notes. Record decision concerning treatment in patient’s
notes, sign and date your entry.
STEP 2: OTOSCOPY
All patients with suspected excessive earwax from step 1 should undergo otoscopy. The nurse
performing otoscopy should be familiar with this procedure.
1. If the ear is not blocked with wax, then the deafness is due to another cause.
Consider if the directive relating to otitis media applies. The patient should be offered
an appointment with a GP.
2. If the ear is blocked with pus or other matter, then the patient should be offered a
GP appointment
3. If the ear is blocked with wax, then proceed to step 3.
Record negative and positive findings in the patient’s notes. Record whether an appointment
was offered. Sign and date your entry
STEP 3: TREATMENT
If you have reached this step, then the patient has excessive earwax.
Almond oil is the treatment of first choice. This should be supplied according to the regimen above, for
a minimum of 3 days, until the patient can re-attend for review.
If almond oil is contraindicated, then sodium bicarbonate should be supplied according to the regimen
above, for a minimum of 3 days, until the patient can re-attend for review.
If the patient requests same day syringing, then warm water should be instilled into the affected ear,
and the patient should wait for 15 minutes. After this interval, syringe the ears according to the
protocol and training given. : see step 4.
If the patient re-attends for review after treatment with a softening agent, and there is still wax
present, then syringe the ears according to the protocol and training given. : see step 4.
Record name of medication, dosage and duration of treatment selected in the patient’s
notes. Sign and date the entry. Give the patient a return appointment for review.
STEP 4: EAR SYRINGING
At the appointment for review, check the auditory canal again to see if there is any wax still present. If
the ear is clear, syringing is not necessary. There is an existing protocol for the procedure for syringing
ears, which is attached. The ears should be syringed according to the training given and using the
equipment supplied for the purpose.
After ear syringing, the ear canal should be examined again to ensure that all wax has been removed.
If the patient is still complaining of deafness, then an appointment should be offered.
If the patient suffers from any of the early complications of ear syringing (pain, damage to soft tissue,
perforated ear drum, blood visible in the external auditory canal) then the patient should be discussed
with the duty doctor.
The patient should be advised to make a GP appointment if any of the late complications of ear
syringing occur. This includes pain and itching in the ear, or discharge of pus.
Record treatment in the patient’s notes. Sign and date the entry.
STEP 5: REFERRAL TO MEDICAL STAFF
Referral to medical staff may be appropriate at any of the points identified in the previous steps. If the
nurse is uncertain whether the Directive applies, or if the patient’s condition is causing concern, then
the duty doctor should be asked for further advice. Specific reasons not stated in the steps above for
contacting the duty doctor include:
1. No response to treatment
2. Side effects
3. Patient’s age falls outside the remit of the directive.
ข้อมูลจาก
http://www.druginfozone.nhs.uk/pgd/ProtocolAdmin/files/docfiles/P530.doc