Monograph to the November 2004 issue

Practical Management of the Draining Ear

Symposium

Philip A. Brunell, MD: In May 2004, clinical practice guidelines for the diagnosis and management of acute otitis media (AOM) and otitis media with effusion (OME) were released.^1,2 The AOM guidelines were devised by a subcommittee of the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP). The OME guidelines were devised by a subcommittee of members of the AAP and the AAFP, as well as the American Academy of Otolaryngology—Head and Neck Surgery.

G. Scott Cuming, MD, FAAP The guidelines provide pediatricians with medicolegal protection and assurance that lessening antibiotic use is a prudent approach. In recent years, most pediatricians have been using fewer antibiotics to treat AOM and OME.

The guidelines are among the first treatment recommendations released by the AAP, which indicates they will likely have at least a modest effect on pediatricians’ treatment approach. What are your thoughts on the guidelines?

G. Scott Cuming, MD, FAAP: The recommendations are lengthy and sometimes vague. I disagree with a few areas but, overall, I believe they are good recommendations and provide a satisfactory structured approach to treatment.

The guidelines provide pediatricians with medicolegal protection and assurance that lessening antibiotic use is a prudent approach. In recent years, most pediatricians have been using fewer antibiotics to treat AOM and OME. When I first began my practice in 1978, I focused on eradicating bacteria quickly and did not consider that I was contributing to future bacterial resistance.

I have found that proper pain management can help reduce the overuse of antibiotics. I sometimes see children with no fever who are experiencing severe pain. When I talk to children’s parents, they sometimes tell me that they did not provide their children with treatment for pain because they did not have a fever.

Pediatricians must be diligent about recommending pain medication. If the pain can be eradicated with acetaminophen or ibuprofen, children and their parents will be comforted and parents will be less demanding of early intervention with antibiotics, which may not be necessary.

George McCracken, MD: How do you manage AOM for children of different ages?

Cuming: For children younger than 6 months, I usually prescribe antibiotics. For children 6 to 24 months old who do not appear toxic or overly distressed, I may not prescribe antibiotics if I can follow up within a day or two. In children older than 2 years, I will prescribe an antibiotic as a safety net. One study showed that only 55% of patients used the antibiotic when instructed not to fill the prescription unless symptoms worsened or did not resolve after 48 hours.³

I have seen a reduction in the use of and demand for antibiotics in children, and AOM is not a problem I need to treat as often as I did in the past. Instead, I see more patients with OME who must be followed, but their condition typically resolves with treatment.

Joseph Dohar, MD: Dr. McCracken, what is your opinion of the AOM and OME guidelines?

McCracken: The guidelines are reasonable, but they are based on meta-analyses in which original diagnoses were not verified in some referenced studies. When the referenced study results were combined, some studies may have included patients with OME and other studies may have included patients with AOM, which can cause confusion regarding conclusions and recommendations for treatment of AOM.

Dohar: Most studies that support the guidelines included patients with OME, not AOM.

Brunell: The recommendations acknowledge the quality of the data. However, it is important to remember that they are recommendations and not orders. Recommendations provide pediatricians flexibility in how they are used and suggestions on how to handle a child when the diagnosis is uncertain. According to the recommendations, if a child older than 2 years does not have severe disease or a physician is unsure of a diagnosis, he or she can withhold antibiotic treatment and observe the progress of the condition. Observation is also an option for children 6 months to 2 years of age if disease is not severe and the physician is unsure of a diagnosis. Children with severe disease should be treated with antibiotics.

The current OME guidelines recommend intervention, such as a hearing evaluation, in children with underlying problems, such as intrinsic hearing or learning problems.

The OME guidelines also state when tympanostomy tubes should be inserted. They note the increasing prevalence of OME and the effect it can have on hearing and subsequent adolescent development. The OME guidelines also discuss some of the important complications of OME, such as acute otitis media with tympanostomy tubes (AOMT).

AOM with tubes

Brunell: In the United States, tympanostomy tube insertion is one of the most common surgical procedures performed in children. Otorrhea can occur after tube insertion or tympanic membrane perforations in the absence of tubes.

Philip A. Brunell, MD In the United States, tympanostomy tube insertion is one of the most common surgical procedures performed in children.

Dr. Dohar, how many patients undergo tympanostomy tube insertion annually?

Dohar: Between 800,000 and 1.3 million patients undergo tube insertion annually in the United States.⁴ I see fewer patients with recurrent AOM, whereas the number of patients with OME has increased, which indicates that bacteriology is becoming less of a problem but chronic inflammation is increasing.

Brunell: What is the incidence of otorrhea in patients with tubes?

Dohar: Traditionally, between 15% and 35% of patients with tubes develop otorrhea. However, in one study, between 80% and 90% of patients with tympanostomy tubes experienced at least one episode of otorrhea.⁵

Andrew Hotaling, MD, FACS, FAAP: Otorrhea that occurs within three days of tube insertion differs from otorrhea that occurs weeks or months later. If otorrhea occurs within a few days after tube insertion, it should be considered a sequela rather than a complication.

Brunell: Data show that AOM with an intact eardrum is a self-limiting disease in many cases.^6,7 OME is a common sequela of AOM. Almost all children with AOM develop effusion. However, effusion usually resolves within three months,² which is why tube insertion should not usually be considered for children before this time.

Cuming: I never automatically recommend insertion of pressure equalization tubes in children with persistent OME or recurrent AOM. Patients’ progress should be observed closely before intervention with tubes. Factors such as a child’s age, developmental progress and comorbid conditions such as Down syndrome also should be considered.

After reviewing the AOM and OME guidelines’ recommendation for better communication between pediatricians and ear specialists, I changed my referral patterns. I now send a short history and supportive evidence for my diagnosis to otolaryngologists.

Brunell: How is AOMT different than AOM behind an intact eardrum?

AOMT is different than AOM in terms of potential mechanisms of infection. AOM and AOMT begin in the eustachian tube and the nasopharynx, where the pathogens originate. However, AOMT might also originate from the external auditory canal. — Joseph Dohar, MD

Dohar: AOMT is different than AOM in terms of potential mechanisms of infection. AOM and AOMT begin in the eustachian tube and the nasopharynx, where the pathogens originate. However, AOMT might also originate from the external auditory canal.

The microbiology of AOM and AOMT also differs. Pseudomonas aeruginosa and Staphylococcus aureus might cause AOMT. In addition, Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis are commonly isolated in AOM and AOMT. Clinical presentations of AOM and AOMT also differ. Otorrhea indicates AOMT whereas fever and hearing impairment likely indicate AOM.

Brunell: How does AOMT progress to chronic suppurative otitis media (CSOM)?

Dohar: In studies that have been conducted outside of the United States, where CSOM is a more significant problem, a diagnosis of CSOM was not considered until six to 12 weeks of treatment failed and persistent drainage remained.^8,9 In the United States, physicians generally diagnose CSOM after three weeks of persistent drainage.

Brunell: Dr. Cuming, how many cases of chronic drainage do you manage?

Cuming: I see fewer cases of chronic drainage because of better therapies, such as ciprofloxacin-dexamethasone (Ciprodex,^* Alcon Laboratories, Inc.). Since ciprofloxacin-dexamethasone has been approved, I see fewer than 12 cases of chronic drainage per year. If patients do not respond to treatment, I refer them to a an otolaryngologist.

Dohar: When I began practicing in Pittsburgh in 1992, many children were treated intravenously for CSOM. However, I admitted fewer than five children for intravenous antibiotic treatment of CSOM this past respiratory season (i.e., October to May). I do not think this change occurred because fewer cases of respiratory illness are occurring or resistance rates are decreasing, but because care provided by physicians has improved and better therapeutic options are now available.

Brunell: Dr. Cuming, when will you refer patients with CSOM and drainage to a specialist?

Cuming: I usually wait approximately three weeks or until two courses of treatment have failed to halt otorrhea.

Dohar: If patients have shown some improvement but drainage persists, will you still refer them?

Cuming: Yes, I will refer them. Otorrhea that is present after three weeks of therapy is indicative of a significant problem that should be evaluated by an otolaryngologist.

Dohar: Would any specific sign or symptom trigger an earlier referral?

Cuming: I have encountered occasional cases in which I cleaned ear canals at the first seven- to 10-day follow-up visits and the tympanic membrane was deformed, the pressure equalization tube was not in its proper position and excessive granulation tissue existed. In such cases, I immediately referred the patients to a specialist.

Dohar: Should pediatricians treat patients with bloody otorrhea?

Hotaling: Pediatricians can treat patients with bloody otorrhea within three weeks of the beginning of an infection. I tell parents that one sign of an infection with tubes is bleeding from the ear.

Brunell: How do you proceed after a child suspected of having chronic drainage is referred to you by a pediatrician?

Hotaling: I first obtain a patient history, including the initial diagnosis and therapies that have been used. If what I consider appropriate therapy has not been prescribed for patients, I will prescribe a fluoroquinolone-steroid combination.

Rick A. Friedman, MD, PhD Whether a hole in the membrane should be closed depends on several factors, including the child’s age, size of the perforation and history of recurrent AOM.

If appropriate medication has been prescribed and the patient has been compliant, surgery is probably warranted. During surgery, I will remove the tympanostomy tube, obtain a culture of the middle ear and wash the tube with Betadine solution (Purdue Pharma L.P.) and then with mild acetic acid. I then reinsert the tube and begin topical therapy. I will initiate more directed therapy after I receive results from the culture.

Brunell: One recent study discussed structural eardrum changes of the tympanic membrane.¹⁰ How frequently do you see such changes in your practice?

Dohar: I sometimes see structural eardrum changes, but I rarely encounter a case in which tympanic membrane changes impact hearing.

Brunell: How often do you surgically close a hole in the membrane that did not seal after a tube was inserted, and how is closure performed?

Rick A. Friedman, MD, PhD: Whether a hole in the membrane should be closed depends on several factors, including the child’s age, size of the perforation and history of recurrent AOM. If the hole is large, it may be closed by a fat myringoplasty in which a piece of fat is removed from the child’s earlobe and inserted in the hole. However, I typically perform a tympanoplasty in which I remove connective tissue from under the skin and rebuild the eardrum.

Hotaling: I surgically close holes in fewer than 5% of the patients I see. Membranes typically seal, but if they do not, parents usually are not concerned about the surgery because of the improvement in their child’s progress due to tube insertion.

I will not close a hole in one eardrum until the other ear has been free of infection for one year because if the other ear becomes infected, a tube may have to be inserted, creating another hole.

Water issues

Brunell: What do you recommend to patients with AOMT regarding swimming and bathing?

Hotaling: Some studies indicate that swimming does not affect the prevalence of otorrhea in patients with tubes while others indicate the contrary.^11-13 Studies that report the prevalence of otorrhea fail to address the trigger of the episode.

I always tell parents of children with tubes that their children should use ear plugs when swimming. I routinely see children whose plugs fell out while swimming and they required treatment for ear drainage. — Andrew Hotaling, MD, FACS, FAAP

I always tell parents of children with tubes that their children should use ear plugs when swimming. I routinely see children whose plugs fell out while swimming and they required treatment for ear drainage.

Brunell: One study surmised that one of the reasons children who live in urban areas have higher amounts of otorrhea than children who live in suburban areas is failure to protect their tubes with ear plugs while swimming and bathing.⁵

Dohar: I believe changes in the physiologic homeostasis of the ear canal cause outer and middle ear infections. In patients with tubes who swim without ear plugs, the water may eliminate cerumen, which increases the pH of the ear canal and removes the natural protective barriers of the ear canal. In turn, conditions for otitis externa are created. Similarly, S. aureus and P. aeruginosa are not present in a normal, healthy middle ear if physiologic changes to the ear canal do not occur. P. aeruginosa, which thrives in moisture, gains access to the ear canal and multiplies when the homeostasis of the canal changes.

Brunell: What is the flora of a normal ear canal?

Dohar: A normal ear canal primarily contains coryneforms.¹⁴ Gram-negative bacteria or yeast are rarely found in a normal ear canal. Among the gram-positive bacteria, Alloiococcus otitidis (i.e., aerobic cells arranged in clusters) is most commonly found. Staphylococcus epidermidis, S. auricularis and diphthereoids are also predominant, and anaerobic organisms, Propionibacterium acnes and anaerobic cocci are present to a lesser extent.¹⁵

Diagnosing the condition

Brunell: Are more patients referred to specialists today with the correct diagnosis compared with 10 years ago? Have pediatricians become more astute in treating ear infections?

Friedman: Pediatricians have become more astute in diagnosing and managing ear infections and referring patients to otolaryngologists only when necessary.

Dohar: In the past 18 months, I have begun receiving referrals that explain patient history, which is information I never used to receive.

Otitis media can be difficult to diagnose. A study by Michael Pichichero, MD, and Michael Poole, MD, demonstrated that pediatricians correctly diagnose otitis media approximately 50% of the time.¹⁶ In the study, even otolaryngologists were incorrect in approximately one in four cases.

McCracken: In the study by Dr. Pichichero and Dr. Poole,¹⁶ OME was evaluated based on videotaped pneumatic otoscopic examinations of tympanic membranes. I have viewed the films and believe they do not necessarily correlate with what physicians see through their otoscopes, which explains why only 50% of pediatricians correctly diagnosed otitis media. However, most pediatricians do not undergo adequate training in diagnosing ear infections and using pneumatic otoscopy during their residency. Some residents are shown how to perform a myringotomy and examine bacteria under a microscope, but in most programs, training on correctly diagnosing ear infections is inadequate or nonexistent.

Pediatricians have become more astute in diagnosing and managing ear infections and referring patients to otolaryngologists only when necessary. — Rick A. Friedman, MD, PhD

Hotaling: When I train otolaryngology residents, they use a pneumatic otoscope on a patient under anesthesia before a myringotomy. After they look at the ears, I ask them to select: cannot view because of wax, in which case they need to remove wax so they can see more clearly; no effusion; or effusion.

Initially, postgraduate year-two residents often diagnose incorrectly, but they diagnose correctly more often by the end of training.

Cuming: Examining a patient under anesthesia is easier than examining a 6-month-old patient with Down syndrome who has a stenotic ear canal, is screaming and whose mother cannot hold down his or her arms and does not want the child restrained. We sometimes encounter such cases. If the patient’s history indicates uncomplicated AOM and I am unable to clean the ear canal, I may treat the patient and refer him or her to an otolaryngologist for follow-up in 10 days. If I suspect the patient has OME, I will refer him or her to an otolaryngologist for evaluation. This scenario is uncommon, but when it does occur, pediatricians become adept at handling uncooperative patients in a compassionate manner without anesthesia.

Hotaling: If the parent does not want the child restrained, it is appropriate to refer the patient to an otolaryngologist.

Treating the draining ear

Dohar: Dr. Cuming, how do you treat a child with a draining tympanostomy tube?

George McCracken, MD ... most pediatricians do not undergo adequate training in diagnosing ear infections and using pneumatic otoscopy during their residency. Some residents are shown how to perform a myringotomy and examine bacteria under a microscope, but in most programs, training on correctly diagnosing ear infections is inadequate or nonexistent.

Cuming: I would inquire when the tubes were inserted, for how long drainage has been occurring and if other symptoms, such as fever or irritability, have been occurring. If the drainage is uncomplicated, I would treat the infection topically with ciprofloxacin-dexamethasone.

Dohar: How do you treat a 2-year-old child with tubes who has had pus draining from his nose and ears for two days, is somewhat fussy and has a parent who will comply with your instructions?

Cuming: I would use ciprofloxacin-dexamethasone topically if I believed the child had a viral upper respiratory infection (URI) with AOMT and check back with the patient’s parent in one to two days.

Brunell: Why not use a systemic antibiotic?

Cuming: If the child has sufficient systemic symptoms, I would also use a systemic antibiotic. However, I would not automatically use a systemic antibiotic for the same reason I do not use it in all cases of uncomplicated AOMT — I am confident that topical medications will eradicate the infection in most of these cases. The newer generations of topical combination otic preparations, such as ciprofloxacin-dexamethasone, effectively treat AOMT in children with no apparent risk of ototoxicity (See sidebar),¹⁷ and I have successfully treated patients topically in the past.

I would inform the parent that drainage should stop within a week and would ask my staff to call the parent as a follow-up within the next two days. I would also schedule an appointment to see the child again in approximately seven to 10 days. I am sure that most otolaryngologists do not want to recheck every ear in which tubes have been inserted, so unless a tube has extruded prematurely, is plugged, will not unplug or otorrhea persists for two to three weeks, I will manage the patient.

Dohar: Some pediatricians have been told that with an intact ear drum, fluid behind the tube does not necessarily indicate an infectious inflammatory response. However, pus draining from a tympanostomy tube is indicative of a bacterial infection.

When pus is leaking from a tube, it is typically accompanied by a URI. According to the criteria of Ellen Wald, MD, purulent rhinitis (i.e., (thick, opaque, or discolored nasal discharge) must be present for at least a week to 10 days to be indicative of sinusitis.¹⁸

Brunell: Purulent rhinitis frequently accompanies the common cold. According to recent data, purulent rhinitis is not an indication for antimicrobial treatment unless it persists without improvement for at least 10 to 14 days because many children with the common cold may still experience symptoms at seven days.¹⁹

Dohar: Regarding the 2-year-old patient, would you change your treatment approach if, after cleaning the ear canal, blood appears in the drainage?

Cuming: I would not change my treatment approach because blood is part of the inflammatory process. I would still prescribe a topical antibiotic-steroid combination, such as ciprofloxacin-dexamethasone.

Dohar: When significant granulation tissue is present, I would use steroids. Even when no granulation tissue is present, data still favor steroid use.²⁰

Joseph Dohar, MD My colleagues and I have conducted studies in which we shined a Wood’s ultraviolet lamp on the nasopharynx of patients who received topical fluoroquinolones. We pumped the tragus aggressively and saw fluorescence indicative that the antibiotic had entered the nasopharynx.

Cuming: If granulation tissue around the tube does not clear up after a seven- to 10-day course of topical ciprofloxacin-dexamethasone, even in a patient who is no longer experiencing drainage, I would refer him or her to an otolaryngologist for further care.

Dohar: Drs. Hotaling and Friedman, if a 2-year-old patient with granulation and an open tube that has been in place for three months has been referred to you, what would you do?

Hotaling: I would continue to use a topical drop with a steroid for another 10 days to attempt to remove the granulation.

Friedman: Drainage through a tube sometimes can be fungal after several courses of topical antibiotics so stopping drops and keeping the ear dry may cause improvement. However, if improvement does not occur, I would remove the tube because the tube could be causing infection. Removing the tube typically results in improvement.

Brunell: What is the mechanism by which a topical fluoroquinolone appears in the nasopharynx?

Dohar: From the middle ear, the antibiotic traverses the eustachian tube and reaches the nasopharynx. My colleagues and I have conducted studies in which we shined a Wood’s ultraviolet lamp on the nasopharynx of patients who received topical fluoroquinolones. We pumped the tragus aggressively and saw fluorescence indicative that the antibiotic had entered the nasopharynx (unpublished data).

McCracken: Physicians are concerned about the effect of topical antibiotics on the bacterial flora of the nasopharynx when antibiotics are used for two to three weeks. I have not seen any data that provide an answer regarding how long antibiotics can be used without promoting resistance.

Dohar: My colleagues and I examined 1,234 isolates of P. aeruginosa from children’s ear drainage at a time when polymyxin B had been used extensively for three decades.²¹ We found no resistance to polymyxin B, which had been used topically in products for 30 years but was never used systemically.

Cuming: Topical otic antibiotics are safe and effective and resistance may be less likely to occur than it is with systemic antibiotics.²²

Recommendations on potentially ototoxic antibiotics applied topically to the middle ear1 The American Academy of Otolaryngology–Head and Neck Surgery consensus panel devised the following recommendations for safe treatment of middle ear infections and the faculty have responded to their recommendations: Topical antibiotic preparations that are not potentially ototoxic should be administered instead of topical preparations that may cause otologic injury if the middle ear or mastoid is open. Dohar: I would prescribe an alternative if a patient is sensitive to a fluoroquinolone, such as a child with cystic fibrosis who has been exposed to numerous fluoroquinolones. If antibiotic drops that may be ototoxic are prescribed for use in the open middle ear or mastoid, the patient and/or parent should be warned of the risk of ototoxicity. Hotaling: Informed consent may be necessary if patients are allergic to fluoroquinolone drops and need aminoglycoside drops. However, if patients are not allergic to fluoroquinolone drops, these are the preferred drops. If antibiotics that may be ototoxic are prescribed, patients should be instructed to call their physician or return to their physician’s office if they develop dizziness, vertigo, hearing loss or tinnitus. Cuming: These symptoms are also potential complications of AOM. If the tympanic membrane is known to be intact and the middle ear and mastoid are closed, use of preparations that may be ototoxic presents no risk. Cuming: This does not apply to patients with AOMT because tubes compromise the barrier, although it may be plugged by the infection initially. Roland PS, Stewart MG, Hannley M, et al. Consensus panel on role of potentially ototoxic antibiotics for topical middle ear use: Introduction, methodology, and recommendations. Otolaryngol Head Neck Surg. 2004;130(3 Suppl):S51-56.

Steroids

Brunell: Does evidence that steroid use will shrink granulation tissue exist?

Hotaling: I am not aware of any published data, but based on my experience, steroid use can shrink granulation tissue.

Friedman: Based on my experience, steroid drops that contain dexamethasone can reduce inflammation, including granulation.

Dohar: Granulation tissue may occur because of an infection, such as trapped epithelium or a foreign-body response to a tube. I have seen granulation tissue form because of an allergy to a tube, which is why the use of an antibiotic plus an anti-inflammatory agent, such as ciprofloxacin-dexamethasone, is the best strategy for treatment of AOMT (See figure).

I would continue to use ciprofloxacin-dexamethasone for four weeks. I cannot prove that topical ciprofloxacin-dexamethasone penetrates deep into granulation tissue, but data have shown that cipro-floxacin-dexamethasone is significantly more effective than ofloxacin (Floxin, Daiichi Pharmaceutical) in resolving tissue granulation.²⁰

Follow-up visits

Cuming: How can I differentiate a patient who needs to be treated for seven days from a patient who needs to be treated for two to four weeks if I cannot clearly see the tympanic membrane?

G. Scott Cuming, MD, FAAP Topical otic antibiotics are safe and effective and resistance may be less likely to occur than it is with systemic antibiotics.22

Friedman: I prescribe medication for seven to 10 days and then see a patient for a follow-up. If the problem still exists, I will continue treatment until the problem is resolved.

Cuming: How should I handle a patient presenting with a mucopurulent otorrhea, with or without blood streaks, who had been treated with ciprofloxacin-dexamethasone for seven days during which a parent or patient reports that otorrhea subsided but returned by the follow-up visit seven to 10 days later?

Hotaling: First, the patient should be seen at seven days because treatment with ciprofloxacin-dexamethasone will be completed.

Brunell: If a patient’s condition has not resolved at seven days, would you suggest adding oral amoxicillin/clavulanate (Augmentin, GlaxoSmithKline) to the topical regimen?

Hotaling: If drainage is still occurring at seven days, topical therapy can be considered. If drainage is still occurring at 14 days, a culture should be taken through the tube.

McCracken: At the AAP annual meeting in 2003, a panel of experts discussed patients with a draining ear and tube. Everyone agreed that if systemic signs are present, a topical and systemic agent should be used as first-line therapy. If patients do not respond after seven to 10 days, the panel recommended a referral to a pediatric otolaryngologist.

Dohar: A culture should be performed on patients who are still draining after seven days of appropriate therapy. The data show that patients should have improved symptoms after seven days and, if they do not, obtaining microbiologic data is helpful.

Hotaling: However, most otolaryngologists and pediatricians are not able to obtain pus from the middle ear and plate it within one hour. I work at three sites and I do not have a messenger who can take a sample to a lab and have it plated within one hour.

Even if a child has failed treatment at seven days, most otolaryngologists would continue topical treatment for two to three weeks. At that point, if no improvement is apparent, then I would consider obtaining a culture.

McCracken: I do not think a child should be referred after only seven days unless something unexpected occurs.

Hotaling: Even if pediatricians have access to a lab, I do not think a culture after seven days should be advocated. Most pediatricians will obtain a culture from the ear canal and not the middle ear, which is of little use.

Figure At baseline, more patients in the ciprofloxacin- dexamethasone group experienced more granulation tissue than patients in the ofloxacin group. However, ciprofloxacin- dexamethasone resolved granulation tissue faster than ofloxacin.

Cuming: Properly obtaining a representative culture of the middle ear can be difficult for pediatricians because they would need to clean the middle ear with gentle suction and then sample the lumen of the tympanostomy tube. It is unrealistic for pediatricians to culture patients in their office when an operating microscope, proper suction, sampling devices and ready access to culture media and proper incubation are necessary to obtain valid results on which therapy should be based.

Brunell: Will the culture of pus in the ear canal correlate with the pus in the middle ear or does a culture need to be obtained through the tube?

Dohar: The culture should be obtained through the tube.

Brunell: How would the culture results lead you to initiate a different course of treatment than a pediatrician would follow after one week of failed treatment?

Dohar: If I am obtaining a culture, I assume that drug delivery is still the impairing factor, which is why I introduce a systemic agent in a culture-directed fashion.

Brunell: What pathogens do you commonly find in the pus cultures?

Dohar: P. aeruginosa is a common pathogen found in pus cultures. In my institution, 43% of the P. aeruginosa strains from community-acquired otorrhea are sensitive to trimethoprim-sulfamethoxazole.²⁰ Therefore, I often prescribe systemic trimethoprim-sulfamethoxazole. If trimethoprim-sulfamethoxazole is not effective, I will prescribe a systemic fluoroquinolone.

Treatment of AOMT

Brunell: What do the data say about cure rates of systemic vs. topical therapy?

Dohar: The only published study comparing systemic therapy to topical therapy in patients with AOMT compared topical ofloxacin and systemic amoxicillin-clavulanate.²³ No statistically significant difference in cure was found. However, this study excluded children in whom P. aeruginosa was the sole pathogen causing the infection, which eliminated 34 patients. If those patients had not been excluded from the study, the patients treated topically would have been at an advantage.

Brunell: How often is P. aeruginosa a pathogen in AOMT?

Joseph Dohar, MD Many physicians assume that only acute pathogens emerge from draining tubes, but studies have shown a pure culture of P. aeruginosa in 30% to 35% of all patients with AOMT.24,25

Dohar: Many physicians assume that only acute pathogens emerge from draining tubes, but studies have shown a pure culture of P. aeruginosa in 30% to 35% of all patients with AOMT.^24,25 During the summer, when older children swim more often, an increase in cases of AOMT with P. aeruginosa as the sole pathogen occurs.

P. aeruginosa is not normal flora in the ear, but when conditions become altered, it is. According to Peter Roland, MD, and colleagues, S. pneumoniae is present in 16.8% of AOMT cases, S. aureus in 13%, P. aeruginosa in 12.7%, H. influenzae in 12.4%, S. epidermidis in 10.2% and M. catarrhalis in 4.1%.²⁰

My colleagues and I examined the results from our acute otorrhea studies over the past seven years and P. aeruginosa was the number one pathogen, followed closely by S. pneumoniae.

McCracken: Is P. aeruginosa more likely to be present four or five days after a tube begins to drain than it is immediately after insertion?

Dohar: If drainage persists, the microbiology converts to P. aeruginosa, probably because the pH in the ear canal changes and the typical recirculation phenomenon begins. Itzhak Brook, MD, and colleagues performed a study examining aspirates from the middle ear and the external auditory canal in children with chronic otorrhea immediately after the removal of a tympanostomy tube.²⁴ They found aerobic bacteria, most commonly P. aeruginosa and S. aureus, in 50% of the middle or external ear isolates obtained.

My colleagues and I conducted a study in which we obtained an aspirate sample with a small cotton swab and after day three, a large number of P. aeruginosa pathogens were observed in pure culture, so P. aeruginosa can survive better than S. pneumoniae within the middle ear.

Brunell: What will you use to combat P. aeruginosa?

McCracken: Ciprofloxacin is the only orally administered drug that works systemically for P. aeruginosa.

Brunell: If you complete a Gram stain of middle ear aspiration, what do you see?

Some studies have shown that combination therapy can be more effective than fluoroquinolone therapy alone.26 — George McCracken, MD

Dohar: When you obtain a culture of a draining ear with a Gram stain and isolate acute pathogens, white cells are usually visible. When pure cultures of P. aeruginosa in concentrations of 10⁴ and higher are isolated, white cells are rarely visible. Pus drains from the ear, and the drainage being cultured is usually a pure culture of P. aeruginosa, but no white cells exist.

Surprisingly, the appearance of the otorrhea is indistinguishable from pus with S. pneumoniae, which is teeming with white cells, but on Gram stains of P. aeruginosa, no white cells in pus exist.

Cuming: What occurs at the mucosal level inside the middle ear? Does a barrier phenomenon that eliminates an immune response occur?

McCracken: Pus does not describe what is happening. Pus implies white cells, but if bacteria are grown to 10⁷, it appears cloudy.

Dohar: This phenomenon is otorrhea.

Brunell: Is the use of a topical fluoroquinolone alone or combination therapy preferred in patients with AOMT?

Cuming: The literature supports combination therapy for patients with AOMT because it results in a higher cure rate in patients with a draining ear.¹⁷

McCracken: Published data have not shown any drawbacks in the initiation of therapy with a combination drug such as ciprofloxacin-dexamethasone in the middle ear. Some studies have shown that combination therapy can be more effective than fluoroquinolone therapy alone.²⁶

Dohar: Are there any local ecologic concerns about a short-term, high dose of a topical steroid? Would its use encourage a secondary or mycotic-type infection?

McCracken: A potential effect on lymphocytes is one concern.

Dohar: Do concerns exist about short-term down-regulation of mucosally produced immunoglobulin A (IgA)?

McCracken: I do not believe that down-regulation of mucosally produced intestinal IgA is a significant concern. However, topical steroids can down-regulate local production of cytokines and chemokines, which could be beneficial from an inflammatory standpoint.

Dohar: If early introduction of a topical steroid were routine, would down-regulation be more likely to blunt the host inflammatory response to the invading pathogen and help reduce the number of failures?

McCracken: I doubt early introduction of a topical steroid would be effective, but I do not think it would be harmful.

Cleaning the ear

Brunell: How important is suctioning when cleaning the ear of a patient with AOMT?

Hotaling: Suctioning is helpful to increase the chance for a cure. If parents perform aural toilet on a daily basis, the treatment can better reach the target site.

Otolaryngologists can use an operative microscope to look at the middle ear and safely suction the ear canal and the tube. They also can obtain a culture from the tube through the microscope.

Brunell: Dr. Cuming, how do you clean a patient’s ear?

Cuming: I use an ear curette wrapped in a small amount of cotton for the copious discharge in the distal portion of the ear canal, but suction would be much easier and probably better tolerated by my patients. In the past, I was not as diligent about performing aural toilet as I am now, which may have contributed to some treatment failures.

Hotaling: The ear canal must be thoroughly cleaned prior to drug delivery. Instilling the drug in the office after cleaning the canal ensures the drug will reach its intended target. It is also an effective method of showing parents the proper method of drug delivery.

Dohar: When I suction a patient’s ear, I show parents how to hold their children, pull the ear up and back and administer the drops so they enter the middle ear. Most importantly, I show them how to pump the tragus. In a study my colleagues and I performed, zero nasopharyngeal fluorescence occurred when tragal pumping was not performed (unpublished data).

The ear canal must be thoroughly cleaned prior to drug delivery. Instilling the drug in the office after cleaning the canal ensures the drug will reach its intended target. It is also an effective method of showing parents the proper method of drug delivery. — Andrew Hotaling, MD, FACS, FAAP

Cuming: How frequently do patients with otorrhea experience enough pain that tragal pumping is not well tolerated?

Dohar: For patients with AOMT, pain is rarely an issue. If pain occurs, it is caused by otitis externa or a blocked tube.

Cuming: Do you encourage parents to clean the canal before they ad-minister topical drops?

Hotaling: I do not encourage parents to clean their children’s ear canal and I tell them to put nothing smaller than their elbow into their child’s ear.

Dohar: I have retrieved cotton and toilet paper from patients’ ears. I had one patient whose otorrhea improved, but when his mother brought him back three weeks later, it had started again. There was no associated upper respiratory infection, but there was toilet paper in the medial aspect of the canal.

I suggest that parents use a warm washcloth at bath time to clean the pinna.

Hotaling: Although I discourage parents from cleaning their children’s ears, physicians should always clean their patients’ ears to ensure that the vehicle can reach the middle ear.

Cuming: I do not think most pediatricians perform suction in their office, although it would be helpful. Without suction, examining the middle ear in a draining ear can be difficult. When I see children with tubes and profuse drainage, I will see them again in seven to 10 days to ensure the tube has not been extruded or plugged and that the otorrhea has subsided.

Hotaling: If suction is not used, how confident are you that the drop will reach the middle ear?

Cuming: To help the drop reach the middle ear, I will occasionally insert a fenestrated ear wick.

G. Scott Cuming, MD, FAAP To help the drop reach the middle ear, I will occasionally insert a fenestrated ear wick.

Hotaling: Typically, as the drops work, the wick falls out as the edema resolves in the canal, which allows the drop to reach its target.

I use wicks when it is apparent that the drop will not go through the ear canal to reach the drum without insertion of a wick.

Brunell: Do you use commercial wicks?

Hotaling: I typically use a Pope otowick (fenestrated) (Medtronic Xomed, Inc.).

Brunell: Do you use wicks in patients with AOM and a perforated drum?

Hotaling: I do not insert wicks in patients with AOM and a perforated drum if the canal is open. If the canal is swollen, I will insert a wick.

Dohar: In chronic cases, I will insert a wick if the canal is open and my culture has shown that ear canal pathogens are promoting the chronicity. The best way to keep children with methicillin-resistant S. aureus (MRSA) from needing intravenous vancomycin or oral linezolid (Zyvox, Pfizer) is by using otowicks.

Children with MRSA have identifiable microbiologic prognostic factors, so physicians can determine which factors will be chronic offenders and which children will progress from acute otorrhea to CSOM. Culturing every potential source of MRSA is important for determining the origin of infection. I culture the nasal vestibule, nasopharynx, ear canal and middle ear, and I aggressively treat the location where MRSA is found with topical agents. In the nose, I use mupirocin calcium ointment (Bactroban Nasal, GlaxoSmithKline).

Brunell: What do you use in the ear?

McCracken: Systemic medication does not affect MRSA in the nasopharynx or the ear canal.

Joseph Dohar, MD Physicians cannot predict which children will experience chronic drainage, but I believe that topical medications, specifically ciprofloxacin-dexamethasone, may reduce the chance of chronic drainage.

Dohar: Topical medication can affect the nasopharynx and ear canal. I recently saw the son of a health care worker who had a nasal vestibule with MRSA and was repeatedly getting staphylococcal lymphangitis, chronic staphylococcal sinusitis and MRSA otorrhea, so I inserted a wick. I treated his nasal vestibule with mupirocin calcium ointment, administered a short course of linezolid for the acute sinusitis and otitis and received the first negative culture at day 14, which is fast for MRSA. When microbiology indicates that the external ear canal is the source of the pathogen that is perpetuating CSOM, topical medication has a role.

Physicians cannot predict which children will experience chronic drainage, but I believe that topical medications, specifically ciprofloxacin-dexamethasone, may reduce the chance of chronic drainage.

Cuming: The practice guidelines^1,2 have helped pediatricians redirect and standardize their therapeutic approaches by replacing excessive systemic antibiotic use with topical medications when appropriate.

Hotaling: Many children with disabilities are affected by ear infections. Because hearing is critical for these children, the fastest treatment possible is the best treatment. For children with disabilities and children without disabilities, a topical antibiotic is typically the best treatment.

Brunell: AOMT continues to be one of the most difficult conditions for pediatricians to treat. I hope our discussion on proper management techniques in different patient groups has been helpful. Improved dialogue between pediatricians and otolaryngologists will help physicians select the best therapy and improve patient outcomes.

I would like to thank Infectious Diseases in Children for organizing this discussion and Alcon Laboratories, Inc., for its sponsorship. I would also like to extend my thanks to the faculty members for their participation in this symposium and monograph project.

References

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20. Roland PS, Dohar JE, Lanier BJ, et al. Topical ciprofloxacin-dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes. Otolaryngol Head Neck Surg. 2004;130(6):736-741.
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^*CIPRODEX is a registered trademark of Bayer AG. Licensed to Alcon, Inc. by Bayer AG.

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