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