HK J Paediatr (new series) 2006;11:76-83 Guideline Review Clinical Practice Guideline on the Diagnosis and Management of Acute

BCC LAM, YC TSAO, Y HUI

Introduction acute , we would like to bring the College members and fellow's attention to two recently published Acute otitis media is a common paediatric condition clinical guidelines on otitis media. One is from the encountered by general paediatricians in private practice. Scottish Intercollegiate Guideline Network (SIGN)1 and This is also the most common infection for which the other from the American Academy of Pediatrics (AAP) antibiotics are prescribed for children. and the American Academy of Family physicians.2 The clinical management of acute otitis media is one Both guidelines are developed based on critical review of the topics proposed by the working group for the of the current best evidence, but in the context of development of clinical management guidelines as it different health care systems. satisfied the selection criteria for guideline development The following review is a summary of the key by the College which includes: (1) Common conditions recommendations from the two guidelines. Similarities and especially in the ambulatory settings; (2) Performance differences between these guidelines are highlighted. Two gap between the evidence based/best practice and the local experts, Dr. YC Tsao, a senior paediatrician and current practice; (3) Availability of good quality/high Dr. Hui Yau, an ENT surgeon, were invited to write level of evidence for a evidence-based guideline. commentaries on these 2 clinical guidelines with particular For this guideline, the working group would like to emphasis on the relevance of the recommendations to the try a new approach towards introducing clinical local settings based on the local epidemiology and their guidelines to local paediatricians. Instead of developing perspective as a paediatrician and an otolaryngologist. the guideline by going through a labour intensive and Readers are strongly encouraged to refer to the full vigorous process of literature review by our local version of the original guidelines for more detailed guideline development panel, which was the method discussion on the evidence. It is noteworthy to point out adopted in the development of clinical management that the grading systems of the 2 guidelines are different, guideline on febrile convulsion, acute gastroenteritis and which makes the direct comparisons of the strength of evidence difficult.

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China American Academy of Pediatrics & American Academy of Family Physicians. Clinical Practice BCC LAM MBBS, FRCP(Edin and Lond), FHKCPaed Guideline: Diagnosis and Management of Acute Otitis Specialist in Paediatrics Media (Pediatrics; May 2004; 113,5; Health module 2 YC TSAO MBBS, FRCP, FHKCPaed p. 1451)

Department of Surgery, The University of Hong Kong, This evidence-based clinical practice guideline Pokfulam, Hong Kong, China provides recommendation to primary care paediatricians Y HUI MBBS(HK), FRCS(Edin), FHKAM(Orl) for the management of children from 2 months through Correspondence to: Dr BCC LAM 12 years of age with uncomplicated acute otitis media Received August 2, 2005 (AOM). Lam et al 77

The guideline aims to provide a framework for clinical selected children based on diagnostic certainty, age, decision-making, but is not intended to replace clinical illness severity, and assurance of follow-up. judgement or establish a protocol for all children with this condition, and may not provide the only appropriate approach to the management of this problem. Criteria for Initial Antibacterial-Agent Treatment or Observation in Children with The Guideline includes:- AOM • Definition of AOM • Addresses pain management Age Certain diagnosis Uncertain diagnosis • Initial observation versus antibacterial treatment <6 mo Antibacterial therapy Antibacterial therapy • Appropriate choices of antibacterial agents • Preventive measures 6 mo to 2 y Antibacterial therapy Antibacterial therapy if severe illness; observation option if Key Recommendations nonsevere illness

≥2 y Antibacterial therapy Recommendation 1 - Diagnosis A diagnosis of AOM requires: if severe illness; • Recent, usually abrupt, onset of observation option if of middle-ear inflammation and middle-ear effusion nonsevere illness • The presence of middle ear effusion, which is indicated by any of the following: - Bulging of the tympanic membrane Recommendation 3B - Limited or absent mobility of the tympanic • If a decision is made to treat with an antibacterial membrane agent, the clinician should prescribe amoxicillin for - Air-fluid level behind the tympanic membrane most children. - Otorrhea • When amoxicillin is used, the dose should be 80 to • Signs and symptoms of middle-ear inflammation as 90 mg/kg per day. indicated by either • The optimal duration of treatment is uncertain. Based - Distinct erythema of the tympanic membrane or on several more recent studies, the results favour - Distinct otalgia (discomfort clearly referable to standard 10 days therapy for children less than 2 years the ear(s) that result in interference with or and for those with severe disease. For children 6 years precludes normal activity or sleep of age and older with mild to moderate, a 5- to 7- day course is appropriate. Recommendation 2 - Pain Management • The management of AOM should include an Recommendation 4 assessment of pain. If pain is present, the clinician • If the patient fails to respond to the initial should recommend treatment to reduce pain management option within 48 to 72 hours, the • Acetaminophen and ibuprofen (mainstay and clinician must reassess the patient to confirm AOM effective); others include home remedies, topical and exclude other causes of illness. agents, narcotic analgesia, and tympanostomy are of, • If AOM is confirmed in the patient initially managed limited effectiveness or entail potential risks with observation, the clinician should begin antibacterial therapy. Recommendation 3A - Antibiotic Treatment • If the patient was initially managed with an • Observation without use of antibacterial agents in a antibacterial agent, the clinician should change the child with uncomplicated AOM is an option for antibacterial agent. 78 Guideline Review

Recommended Antibacterial Agents for • Factors not amenable to change are genetic Patients Who Are Being Treated Initially with predisposition, premature birth, male gender, Native Antibacterial Agents or Have Failed 48 to 72 American, family history of recurrent otitis media, Hours of Observation presence of siblings in the household, and low socioeconomic status • Temperature At diagnosis for patients being treated Factors amenable for change include ≥ 39°C and/or initially with antibacterial agents of - Altering child care center attendance patterns severe otalgia failed observation - Breastfeeding for at least the first 6 months Recommended Alternative for - Avoiding supine bottle feeding penicillin allergy - Reducing or eliminating pacifier use in the second No Amoxicillin, Non-type I: cefdinir, 6 months of life 80-90 mg/kg per day cefuroxime, - Eliminating exposure to passive tobacco smoke • cefpodoxime, type I: Immunoprophylaxis with killed and live-attenuated azithromycin, intranasal influenza vaccines has demonstrated more clarithromycin than 30% efficacy in prevention of AOM during the respiratory illness season Yes Amoxicillin- Ceftriaxone, 1 or 3 clavulanate, days Recommendation 6 90 mg/kg per day • No recommendation for complementary and of amoxicillin, alternative medicine (CAM) for treatment of AOM with 6.4 mg/kg are made based on limited and controversial data per day of clavulanate Scottish Intercollegiate Guidelines Network February 2003. Diagnosis and Management of Recommended Antibacterial Agents for Childhood Otitis Media in Primary Care – A National Patients who Have Failed 48 to 72 hours of Clinical Guideline (SIGN 66)1 Initial Management with Antibacterial Agents

Temperature Clinically defined treatment failure at Definitions of Acute Otitis Media (AOM) ≥ 39°C and/or 48-72 hours after initial management with severe otalgia antibacterial agents • Inflammation of the middle ear of rapid onset Recommended Alternative for presenting most often with local symptoms (the two penicillin allergy most common being earache and rubbing or tugging No Amoxicillin- Non-type I: of the affected ear) and systemic signs (, clavulanate, ceftriaxone, 3 days; irritability and poor sleep for example) 90 mg/kg per day type I: clindamycin • There may be a preceding history of upper respiratory of amoxicillin symptoms including and component, with 6.4 mg/kg per day of clavulanate Definitions of Otitis Media with Effusion Yes Ceftriaxone, 3 days Tympanocentesis, (OME) clindamycin • Inflammation of the middle ear, accompanied by the accumulation of fluid in the middle ear cleft without Recommendation 5 - Prevention of Recurrence the symptoms and signs of acute inflammation • Clinicians should encourage the prevention of AOM • OME is often asymptomatic, and earache is relatively through reduction of risk factors uncommon Lam et al 79

Diagnostic Features of AOM and OME Treatment for OME

• AOM OME Antibiotics for OME Earache fever irritability Present Usually absent - Children with otitis media with effusion Middle ear effusion Present Present should not be treated with antibiotics [Grade D Opaque drum Present May be absent Recommendation] • Bulging drum May be present Ususally absent Decongestants, antihistamines and mucolytics Impaired drum mobility Present Present - Decongestants, antihistamines or mucolytics Present Usually present should not be used in the management of OME [Grade B Recommendation] • Steroids Treatment for AOM - The use of either topical or systemic steroid therapy is not recommended in the management of children with OME [Grade B Recommendation] • Antibiotics for AOM • Autoinflation - Children diagnosed with acute otitis media should - Autoinflation may be of benefit in the not routinely be prescribed antibiotics as the initial management of some children with OME [Grade treatment [Grade B Recommendation] D Recommendation] - If an antibiotic is to be prescribed, the conventional five day course is recommended at dosage levels indicated in the British National Referral for OME Patients Formulary [Grade B Recommendation] • Decongestants, antihistamines and mucolytics • Children under three years with persistent bilateral - Children with AOM should not be prescribed otitis media with effusion and hearing loss of ≤25dB, decongestants or antihistamines [Grade A but no speech and language, development or Recommendation] behavioural problems, can be safely managed with • Analgesics watchful waiting. - Parents should give paracetamol for analgesia but If watchful waiting is being considered, the child should be advised of the potential danger of should undergo audiometry to exclude a more serious overuse [Grade D Recommendation] degree of hearing loss. [Grade A Recommendation] • Oils • Children with persistent bilateral otitis media with - Insertion of oils should not be prescribed for effusion who are over three years of age or who have reducing pain in children with AOM [Grade B speech and language, developmental or behavioural Recommendation] problems should be referred to an otolaryngologist. • Homeopathy [Grade B Recommendation] - There is insufficient evidence available to recommend homeopathy in the management of AOM (or OME) Patient Issues

• Referral for AOM Patients Information for parents, teachers and carers - Parents of children with otitis media with effusion should be advised to refrain from smoking. • Children with frequent episodes (more than four [Grade B Recommendation] in six months) of AOM, or complications, should - Parents should be advised that breastfeeding may be referred to an otolaryngologist [Grade D reduce the risk of their child developing otitis Recommendation] media with effusion. [Grade C Recommendation] - Grommet insertion is not a contraindication to swimming. [Grade C Recommendation] 80 Guideline Review

Comparison of Two Otitis Media Guidelines Commentaries from Local Experts – Similarities and Differences3 Paediatrician in Private Practice – Dr. YC Tsao

There is strong agreement between the 2 guidelines on: The Guidelines • Diagnostic features of AOM, with the SIGN guideline Otitis media is a common childhood condition. Both highlighting the importance of distinguishing AOM the Scottish Intercollegiate Guideline Network (SIGN) from OME, with different clinical features and in February, 2003 and the American Academy of management emphasis Pediatrics and the American Academy of Family • The recommended option of delayed antibiotic Physicians (AAP & AAFP) in May, 2004 have published treatment guidelines on the diagnosis and management of acute • The antibiotics to be used otitis media for primary care clinicians. • The use of analgesic Both of these guidelines were based on evidence • Some of the risk factors gathered from published data. There is a strong agreement in all the conclusions reached but they differ There are differences in the recommended duration of in the tone of the recommendations. antibiotic treatment and the approach on initial Before we accept these guidelines for our practice, management option. there are several limiting factors we must recognise. Firstly, they only refer to uncomplicated cases of otitis American Academy of Scottish Intercollegiate media. They exclude patients with anatomical Pediatrics Guideline Network abnormalities such as cleft palate, genetic conditions • For younger children and • The optimum duration of such as Down syndrome, immunodeficiencies and the for children with severe treatment for infants and presence of cochlear implants. Also excluded are disease, a standard 10 day very young children, and children with clinical recurrences of acute otitis media course is recommended for children with severe within 30 days or acute otitis media with underlying • For children 6 years of acute otitis media, has yet chronic otitis media with effusion. age or older with mild to to be established The SIGN guideline distinguishes acute otitis media moderate disease, a 5-7 day • If an antibiotic is to be and otitis media with effusion because of different course is appropriate prescribed, the management strategies although recognising that acute conventional five day otitis media may leave a middle ear effusion for a variable course is recommended period of time following resolution of acute symptoms and that the two forms of otitis media should be • If the patient fails to respond • Antibiotic to be collected considered part of a disease continuum. to the initial management at parents' discretion after Both guidelines agree that pain is probably the most option within 48-72 hours, 72 hours if the child has significant symptom of acute otitis media and that it can the clinician must reassess not improved is an be relieved with paracetamol or ibuprofen. the patient to confirm acute alternative approach On the diagnosis of acute otitis media, both agree that otitis media and exclude which can be applied in the sensitivity may be increased by using pneumatic other causes, and start general practice otoscopic examination especially for detecting fluid in antibiotic treatment for the middle ear. The external auditory canal should be confirmed acute OM cleared of cerumen and a well illuminated should be used. Examination can be supplemented by and acoustic reflectometry. The presence The SIGN guideline put more emphasis to alert of fluid can also be demonstrated by tympanocentesis clinicians to watch out for hearing impairment in children or the presence of fluid in the external auditory canal as with recurrent otitis media or otitis media with effusion. a result of perforation. Lam et al 81

SIGN guideline recognised that most primary care There is some benefit from ventilation tube insertion clinicians will use only direct otoscopy. for expressive language and verbal comprehension, but Both guidelines mention that a certain number of the timing of surgery is not critical. patients probably do not need antibiotic treatment and can be watched for 48-72 hours. The AAP and AAFP recommend the "observation How to Translate These Guidelines Into Our option" only for children over 2 years of age, or those Local Practice? between 6 months to 2 years if the diagnosis is uncertain and the illness not severe. For those given the Acute otitis media is diagnosed by the acute onset of "observation option", it is important for the parent / care earache, irritability and tugging of the ear, signs of giver to be able to communicate with the clinician inflammation of the eardrum (change in color, readily. opacification) and fluid in the middle ear (bulging SIGN guideline recommends delayed antibiotic eardrum or perforation of the tympanic membrane treatment for children 6 months to 10 years. The discharging pus). Although mobility of the tympanic antibiotic is to be collected at the parent's discretion after membrane can be better assessed by , 72 hours if the condition of the child has not improved. most of our local primary care clinicians do not use such Only 24% of the parents used the antibiotic. method of examination. The use of antibiotic at the initial visit only serves to When the acute otitis media is not severe and shorten the symptoms by only 1 day in 5-14% of uncomplicated, there is a case for withholding antibiotic children. This should be compared with the avoidance for 48-72 hours, giving only paracetamol or ibuprofen of common side effects in 5-10% of children, infrequent for pain relief and to reduce the fever. serious side effects and the emergence of antibiotic For children less than 6 months of age or for older resistance. children with severe illness, antibiotic treatment should Both guidelines recommend using amoxicillin be started immediately. or amoxicillin with clavulanic acid as the common There is no evidence to show that the use of anti- pathogens involved are Strept. pneumoniae, histamines, nasal decongestants or mucolytic agents H. influenzae and M. catarrhalis. affect the outcome of acute otitis media. They should SIGN guideline recommends the standard five day only be used for other indications. course for uncomplicated ear infection in children. The Children with frequent episodes of acute otitis media AAP & AAFP guideline recommends 10 day course for (>3 in 6 months or > 4 in 12 months), chronic perforation young children and children with severe disease and 5-7 or those who develop complications like and day course for children 6 years of age or older. facial paresis should be referred to the otolaryngolist. Decongestants, antihistaminics and mucolytic agents Otitis media with effusion may persist after an attack have not been shown to be useful in the treatment of or repeated attacks of acute otitis media, or it may be otitis media, neither are topical or systemic steroid asymptomatic and discovered incidentally. Antibiotic therapy. treatment has not been shown to be of benefit. Children Children with frequent episodes of acute otitis media under 3 with mild to moderate hearing loss (≤25 dB) (>3 in 6 months or >4 in 12 months), long standing may be watched. Those over 3 with speech and language effusion (children >3 years of age), chronic perforation developmental delay should be referred. and complications like mastoiditis or facial nerve paresis should be referred to the otolaryngologist. Children who have otitis media with effusion should Perspectives from a Paediatric Otolaryngologist be followed up at 2-3 months intervals. Some may – Dr. Hui Yau resolve by themselves. No difference has been shown in terms of language development, speech, sound Whereas acute otitis media (AOM) and its related production cognition and behaviour between early and pathologies such as otitis media with effusion (OME) delayed grommet insertion. are extremely common conditions in children, it is 82 Guideline Review

important to realise that the pattern of disease has • Pneumo-otoscopy is easy to learn and perform, and changed in Hong Kong and other developed countries gives useful clinical clue to the status of the middle over the last century. ear. In the early years of the 20th century and before • Audiology tests (pure tone audiometry and antibiotics are generally available, AOM usually present tympanometry) are useful adjuncts to diagnosis but clinically as a challenge in sepsis management. Left they should not be interpreted on their own, especially untreated, the infection took one of several routes. It may if the tests are not performed by an audiologist in the perforate the ear drum and drain itself. It may present as proper setting. mastoiditis, and as the bone is thin in children, the pus in the mastoid may track towards the skin forming a Assessment of the Patient subperiosteal abscess, or towards the temporal lobe • After a diagnosis of AOM or OME is made, it is resulting in an intracranial abscess. Therefore, surgery important to assess the hearing and its impact on was often necessary to treat AOM in its advanced form speech development. Pure tone audiometry is the and are usually performed as emergencies. The role of recommended test. If audiology facilities are not surgery was then prominent. Often the parents were available, a thorough history taking usually gives satisfied when the life of the child was saved. The middle useful information. ear was sometimes left in a chronic discharging state. • It is also important to realise that serous otitis media With the improvement in socioeconomic condition, affects hearing to a different extent in different easy access to medical care and the availability of patients. An entirely fluid filled middle ear may result effective antibiotics, nowadays most AOM are readily in an air bone gap of about 30 dB, or the hearing quenched at an early stage. Life threatening sepsis may be close to normal. that requires emergency surgery is uncommon. On the • If the air bone gap is greater than 30 dB, additional other hand, OME becomes more prevalent as a pathology may be present. sequelae of AOM. OME altered the sound conduction mechanism by hindering vibration of the tympanic Treatment membrane and the ear ossicles, resulting in • A wait-and-see policy is mentioned in both conductive hearing loss. The current challenge in the guidelines, generally recommended for the older management of otitis media is the management of child and when the symptoms are not severe. Critical hearing loss and its associated problems. Audiology to the safe adoption of this policy is close monitoring therefore plays an important role, not only in the by an experienced clinician. diagnosis of the condition, but to accurately assess • In addition, if a wait-and-see policy is adopted, and the magnitude of hearing loss so that treatment can hearing loss is significant, remember to send a note be planned. Parents are no longer concerned about to the school teacher for preferential seating in class. the risk to life. they complain about learning Other means of facilitating communication are listed difficulties and learning / behavioural problems. in the SIGN guideline (6.1). These advice are very useful.

Comments on the Guideline Conclusion Diagnosis • It cannot be overstated that a well illuminated My own objective in the management of AOM / OME otoscope is essential. An under-powered otoscope is, through proper selection of treatment modality, to will make the tympanic membrane look dull which provide the child with educationally sufficient hearing resembles the appearance of OME. It is also important for learning and speech development, and to prevent any to remember that crying alone may result in a long term otologic complication that the child may have transient hyperemic tympanic membrane that mimics to live with for the rest of his life. Nowadays in AOM. Hong Kong, this objective is easy to achieve in most Lam et al 83

paediatric patients, but in some, a collective effort Acknowledgement by family physicians, paediatricians, paediatric otolaryngologists and audiologists is necessary. I would like to thank Dr. Patricia Ip, Chairperson of the Treatment should not be entirely focused on infection Professional and External Affairs Committee, and the and its eradication. Hearing loss and its related problems members of the Working Group on Clinical Guideline and are important components of the illness and adequate Evidence-Based Medicine, Hong Kong College of emphasise should be put on the latter aspects of the Paediatiricans (Dr. KH Poon, Dr. Betty Young, Dr. Tong disease. Chi Tak, Dr. Susan Chiu, Dr. Alfred Tam, Dr. Daniel Chiu, Whereas the guidelines are useful, informative and Dr. Bobby Chan Cho Him, Dr. Olivia Chow Kit Wun) for evidence-based, treatment must be individualised as their valuable comment and support. stated in its introduction (SIGN 1.3). Factors like the frequency of recurrences, severity of hearing loss, impact on speech development, behavioral issues, References severity of tympanic membrane retraction, etc., are all factors that we have to consider. More aggressive 1. Diagnosis and management of childhood otitis media in primary therapy like grommet insertion should be considered care. Scottish Intercollegiate Guidelines Network. 2003 Feb. when these unfavourable factors are present or 2. American Academy of Pediatrics and American Academy of Family Physicians. Diagnosis and Management of Acute Otitis persistent. Media. Pediatrics 2004;113:1451-65. Normal hearing and speech ability add enormously 3. J Harry Baumer. Comparison of two otitis media guidelines. to the competitive edge of any individual. Arch Dis Child Educ Pract Ed 2004;89:ep76-ep78.