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It was once the only way to treat acute otitis media. Now it's more useful than ever, the author argues, especially in light of increasing antibiotic resistance. Learn what tympanocentesis can do for your patients and how to perform it in the office.
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By Stan L. Block, MD
It was once the only way to treat acute otitis media. Nowit's more useful than ever, the author argues, especially in light of increasingantibiotic resistance. Learn what tympanocentesis can do for your patientsand how to perform it in the office.
A 13-month-old boy is squirming and crying in his harried mother's lap.She is nearly in tears herself. "He cried all night. I couldn't doanything to console him," she tells you. You examine the toddler, whois afebrile and does not appear toxic or tachypneic, recalling that he isin his fifth day of treatment with cefixime for AOM. The origin of his extremediscomfort shouldn't be his ears. The examis normal and proceeds smoothlyuntil you examine the child's ears and throat--and encounter fierce resistance.His mother can barely keep him within her grasp as he flails and bucks allover her lap.
Finally you and the mother regain some control, only to be thwarted bythe cerumen that partially obscures your view of one tympanic membrane (TM).A cursory glance reveals a red ear. Maybe. The other ear is completely occludedby wax. Your tympanometer or acoustic reflectometer will deliver no worthwhileinformation about the presence of an effusion, much less whether the TMis infected. You examine the child's mouth, hoping that a bad case of herpanginaor herpes simplex will explain his irritability. No luck--all is normal.His nose is totally crusted over with thick green mucus. Maybe it's justhis sinuses. But you know better. Those ears could easily be the "hot"culprit causing the child's misery.
Reluctantly, you lay the child on the table to better restrain him soyou can clean out the cerumen with your curette. It's Monday afternoon andthe office schedule is full. You're two patients behind. After a momentof perseverance with the curette, you spot the right TM--a creamy yellowpurulent effusion with a small bullous bleb on it. Why is it that the "hot"ear always hides behind the wax? Your job is complete. Write the prescriptionand move on.
But looking again at this miserable, inconsolable baby and his distraughtmother, you recall several recent reports in the literature and wonder whetherthe child, who on his third course of antibiotics, may have a multi-drug-resistantstrain of Streptococcus pneumoniae. Most standard antibiotics are unlikelyto eradicate it. "If only I knew how to do that procedure so I couldalleviate his pain and identify the organism," you think. "Bytomorrow morning, I could even choose the best antibiotic." But theoffice is full. You prescribe codeine and amoxicillin-clavulanate and moveon. Maybe the family won't call back tonight. Yet you know that the oddsof achieving clinical resolution are 50/50 at best.
Pediatricians are very comfortable when it comes to performing certain"taps." We readily undertake a spinal tap, sometimes even a bladdertap. Or we might tap an abscess. And we commonly "toe tap" aroundparents' sensitive feelings. Yet we cringe at the mention of the ear tap,or tympanocentesis. Tympanocentesis (TPC) --aspiration of fluid from themiddle ear with a needle to relieve pressure and collect a sample of theeffusion for culture--was the standard treatment for acute otitis media(AOM) in the pre- and early antibiotic eras. Now, only about 100 pediatriciansacross the United States perform TPC at least a few times a year, accordingto a recent article in Pediatric News.1 Even fewer use it asa routine diagnostic and therapeutic procedure for selected cases of AOM.
Alarmingly, marked resistance among bacteria recovered from the middleear has become ubiquitous.2,3 In many cases of AOM, even repeatedcourses of different antibiotics just are not working. Subtherapeutic, long-termantibiotic prophylaxis, coupled with overprescribing in an attempt to appeasefamilies and to be "on the safe side" when treating illnesses,have caused a regression to the therapy of the pre-antibiotic era.4,5Pediatricians are being forced into a "need-to-know" situationregarding middle-ear pathogens for many cases of AOM, and yet only a handfulhave actually documented the bacterial etiology of AOM failures and thedegree of resistance.
A recent report from the Drug-resistant Streptococcus pneumoniae TherapeuticWorking Group of the Centers for Disease Control issued the following recommendation:"In an era of increasing antimicrobial resistance, clinicians treatingchildren with acute otitis media should consider developing the capacityto perform tympanocentesis themselves or establish ready referral mechanismsto a clinician with this capacity."6
Our practice consists of five general pediatricians, who care for thepediatric and adolescent population of two small rural Kentucky hamlets--Bardstown(population 7,000) and Springfield (population 1,800)--and their surroundingcounties. Since its inception in 1976 the practice has used TPC to alleviateseverely painful AOM, treat refractory AOM, and identify a likely pathogenin the toxic child.
We became involved in conducting AOM clinical trials in 1988. We haveroutinely, meticulously cultured every middle ear aspirate. All potentialmiddle ear pathogens are transported to a clinical laboratory for furtheridentification and susceptibility testing to a full panel of antimicrobials.Because we consider these data to be critically important, our group hasdirectly self-funded the testing of all middle ear isolates, even thosenot included as part of a clinical trial, since 1988.
The day is indelibly etched in my memory. On January 18, 1992, duringmy daily morning visit to our small office laboratory to look over the previousday's urine, throat, and occasional middle ear cultures, I picked up thesheep blood agar plate from a middle ear aspiration and was dumfounded.
The plate had grown a pitted a-hemolytic colony that was inhibited bythe optochin disk--typical pneumococcus. Alarmingly though, no zone of inhibitionappeared around the oxacillin disk. "Uh-oh," I muttered. "Nozone"--usually pathognomonic for a penicillin-resistant strain.
I sent the culture plate to the central laboratory for confirmation andsusceptibility testing. The pathogen displayed a minimal inhibitory concentration(MIC) to penicillin of 2.0 mcg/mL (a highly penicillin-resistant strain)along with marked resistance to multiple other antibiotics.
As the story unfolded over the year and we recovered several more isolatesof penicillin-resistant pneumococcus, we realized we had stumbled on anepidemic of AOM caused by this pathogen.7 The resistant isolateswould soon wreak their therapeutic mayhem not only in our practice, butacross the US.2,3
During our first six months of experience with the resistant pneumococcus,no antibiotic seemed able to eradicate it except for several consecutivedays of intramuscular ceftriaxone.7 We also noted anecdotallythat many of the children with refractory AOM improved once the infectedear was drained. We speculated that treating persistent AOM like an ordinaryabscess, which also responds well to surgical drainage, might improve outcome.
Susceptibility testing of pneumococcal isolates from the middle ear wasonce considered a waste of time and money. Without the surveillance datafrom our and others' TPC isolates, however, pediatricians might not havebecome aware of the dramatic change in AOM pathogens for several years.
These data also enabled us to be the first investigators to report thesusceptibility of penicillin-resistantS pneumoniae to clindamycin and treatmentof the pathogen with that drug at the Interscience Conference of AntimicrobialAgents and Chemotherapy in 1994.8 Clindamycin is now one of therecommended oral antimicrobials for AOM caused by penicillin-resistant Spneumoniae.6,9 Thus routine epidemiologic surveillance providedby TPC data and susceptibility testing of some nonroutine AOM drugs hasbecome crucial for optimal antibiotic selection.
Although long held in low regard among otolaryngologists and generalpediatricians,10,11 TPC--once the only way to treat AOM--maybe experiencing a renaissance in the trenches of everyday pediatric practice.Even leading otolaryngologists have reversed their previous anti-TPC positionand now favor its use by primary care pediatricians.10 In lightof increasingly resistant strains of S pneumoniae,the Committee on InfectiousDiseasesof the American Academy of Pediatrics now advocates TPC to managerefractoryAOM.9
Pediatricians are encountering more children with refractory AOM. Yetmany of them are not actually otitis prone but merely unresponsive to standardtherapy during their first or second annual episode of AOM. Lacking an effectivealternative treatment for the current singularly refractory pathogens, pediatricianscustomarily have resorted to inserting pressure-equalizing tubes.12Not only are the tubes expensive, but the delay in placing them is usuallya week or two. Meanwhile, the child often suffers from considerable discomfort.
Roddey has shown that myringotomy significantly relieves acute otalgiain children with painful AOM.13 Any physician who has performedTPC for unrelenting ear pain is impressed by the dramatic relief it provides.Within 15 minutes, patients who were writhing in pain are usually slumberingpeacefully.
Another important benefit of TPC is identification of the infecting organism--akey consideration for infants and children with suspected sepsis or refractoryAOM.14 Although few pediatric academic centers perform or eventeach TPC, many experts at these centers recommend that any infant or youngchild who is hospitalized for presumptive meningitis, bacteremia, or lobaror "toxic" pneumonia and who is also infected with suppurativeAOM should undergo TPC as part of the evaluation.In otherwise healthy, fullyimmunized children with fever and leukocytosis who are being evaluated forbacteremia, TPC is much more likely than blood culture to yield the potentiallyinvading organism (nearly always pneumococcus) for susceptibility testing.15
Does TPC confer any therapeutic advantages in routine initial AOM? Datafrom the 1960s, 1970s, and 1980s are conflicting. Only two of six studiesfrom those decades demonstrated significantly improved therapeutic outcomeswhen TPC was used in conjunction with antibiotics.16
More recently, two clinical trials have demonstrated no therapeutic advantagefor patients with uncomplicated and nonrefractory AOM who were treated withboth TPC and antibiotics, compared to children treated with TPC alone. Engelhardand colleagues performed a randomized, partially blinded clinical trialof 105 Israeli infants, comparing three modes of treatment: amoxicillin-clavulanatealone, myringotomy plus placebo, and myringotomy plus amoxicillin-clavulanate.16AOM resolved otoscopically in only 36% of children treated with myringotomyplus placebo. In contrast, among patients treated with antibiotics, resolutionoccurred in 87% without myringotomy and in 96% with myringotomy.
Kaleida and colleagues reported in a randomized clinical trial of 536children that adding myringotomy to amoxicillin did not improve clinicalcures in children under 2 years of age and that myringotomy alone was significantlyless effective than antibiotics for patients older than 2 years.17Nevertheless, these authors recommended TPC for selected infants and childrenwith severe otalgia, refractory AOM, or suppurative complications. Rememberthat all these outcome data apply only to initial AOM, not refractory AOM,and that they do not reflect the invaluable data obtained from microbiologicalspecimens.
Any physician who can perform a spinal tap should be able to performTPC. The landmarks of the tympanic membrane are clearly visible and moreeasily accessible than those used for lumbar puncture. They are thoroughlyembedded in the visual memory of every pediatrician. Why then don't morepediatricians perform TPC? Here are a few possible answers.
Lack of training. Sadly, few pediatricians have received any formal trainingin TPC. I have observed that a "turf war" often develops betweenthe pediatric and the otolaryngology departments when attempts to teachTPC in a pediatric program are initiated.Concerns are raised about the "safety"of the procedure, the need for adequate operating room time, or anesthesia.11Also, why bother with TPC when a pressure-equalizing tube can be inserted,which creates a much longer lasting (and, rarely, permanent) perforation,costs twenty times more, requires general anesthesia, and can lead to scarring?
Safety concerns. An informal canvass (by personal communication) of otherexperienced otoscopists in the US (James Hedrick, MD, Chris Harrison, MD,Michael Pichichero, MD, Gerson Aronovitz, MD, Sam McLinn, MD, Manford Gooch,MD, and Jeff Blumer, MD), who together have performed over 15,000 TPC procedures,reveals that the incidence of serious complications is virtually nonexistent.Potentialandhypothetical complications include:18
No systematic study of the frequency of the above complications has yetbeen performed. No experienced investigator has observed these problems,however. In any case, as with the insertion of pressure-equalizing tubes,the benefits of TPC in select cases outweigh the risk of basically unreportedand extremely rare complications.
Concerns about pain. TPC is necessarily invasive. Pediatricians oftenfeel uncomfortable about inflicting any pain on patients they have beentrained to heal and comfort. On the other hand, pediatricians are willingto perform spinal taps, urinary catheterizations, bladder taps, venipunctures,suturing, or intravenous sticks (or even the dreaded, controversial circumcision).Why? Because we realize that these are "necessary" or customaryprocedures and usually in the best interests of the child. They are "indicated"as standard care. We have been trained to perform them. I must emphasizethat pediatricians rarely use prior sedation, anesthesia, or postprocedurepain relief for any of these procedures.
In contrast, more than adequate sedative/anxiolytic/amnestic responsecan be induced with simple oral medication prior to TPC. Highly effectiveanesthesia of the TM also can achieved, by instilling topical anestheticssuch as 8% tetracaine. Using 20% benzocaine gel or dabbing the TM with aphenol-soaked swab at the incision site also will usually anesthetize theTM.
TPC is too time-consuming. The procedure does require extra time fromboth the pediatrician and nursing staff (about 15 to 30 minutes each), butthe scenario is similar to that of the acutely ill or trauma patient whomust be squeezed into the office schedule. Moreover, proficiency increaseswith frequency of use, and most of the equipment necessary for TPC is readilyavailable in the office (Table 1). Additional reimbursement for the proceduremay provide some incentive as well.
Even in a fairly large pediatric practice such as ours, where the diagnosisof AOM accounts for over 10,000 office visits a year, we perform TPC atmost 100 to 125 times annually--only when we perceive that it would benefitthe child by alleviating severe symptoms, improving therapeutic response,or aiding microbiologic diagnosis in a very ill child (Table 2).
For refractory AOM I have recommended TPC after failure with the thirdor even the fourth course of antibiotics. I am concerned about recommendationsthat TPC be performed routinely in AOM after failure with a second courseof antibiotics. This would be both overwhelming and discouraging for thepediatrician. In the 1990s persistent AOM accounts for 20% of AOM episodes.
Children requiring TPC are never anticipated and are scheduled only enoughtime for a routine office visit. If TPC were performed routinely after thesecond course of antibiotics failed, the time demands and disruption tooffice flow for the busy pediatrician (or otolaryngologist upon referral)would be inordinate and impractical in the busy winter season, when antibioticfailures become exceedingly commonplace, and TPC would need to be performedmultiple times daily.
Any of the instruments described in Table 3 can be used to perform TPC."How to perform TPC in the office," outlines the procedure.
The Alden-Senturia trap. I personally recommend the Alden-Senturia trapmade by Storz because it is easy to use and can be reused. Its major drawbackis that the metal tubing must be rinsed out and cleaned immediately aftereach use to prevent it from becoming occluded with blood and debris. A thinwire stylet is provided for cleaning, but I have found that routine cleaningwith a Calgiswab works better.
The Tymp-Tap. Nearly identical in configuration and ease of use to theAlden-Senturia trap, the disposable Tymp-Tap becomes significantly morecostly as the number of procedures per season increases.20 Somephysicians may find the disposable instrument more suitable to their needs,however.
The OtoLAM (Otoscan laser-assisted myringotomy). Set your phaser on stun,Mr. Spock! Every school-age boy and video game junkie dreams of owning hisown ray gun to battle the villainous forces of the universe. The OtoLAMfulfillsthis fantasy perfectly. With this laser "gun," we can point thebeam at the TM and zap a hole in it. The OtoLAM is incredibly easy to use.The parent can even hold the child on the lap during the procedure if anappropriate topical anesthetic is used to anesthetize the TM. More important,the hole created by the OtoLAM remains open for two to four weeks, nearlyten times longer than the slit created by conventional TPC, which only lastsone to four days.
The OtoLAM has two shortcomings, however. First, it costs nearly as muchas a Star Fleet vessel: $73,000--a price that could never be recouped bypediatricians. Second, obtaining a sample of the "villainous"middle ear exudate for culture requires attempting to mop up the exudateoozing from the TM with a cotton swab. By then the child has become apprehensive,and the sample has likely become contaminated. Nevertheless, the instrumentmay be ideal for otolaryngologists who already own carbon dioxide lasertechnology.
Using oral midazolam (Versed) to sedate patients before TPC has beena godsend for our practice. We sedate nearly all children except those youngerthan 6 months of age. I find giving this anxiolytic and amnestic sedativeto be invaluable for future rapport with the child. Sedating the patientcan also allay any misgivings the physician may feel about TPC.
Five years ago we often sedated patients for TPC with the intramuscularconcoction known as DPT (meperidine/promethazine/chlorpromazine in a 2/1/1mg/kg/dose). The injection was painful and stressful, and adverse reactionssuch as emergence delirium and acute hyperactivity were not uncommon.
Then we began using oral midazolam as described in "In-office sedationwith oral midazolam". Once the midazolam began to take effect (in 10to 15 minutes), it transformed the crying, inconsolable child into a carefree,giddy, garrulous barfly for about an hour. Sedating the child also madeparents much less apprehensive before, during, and after the procedure.
Children in their inebriated condition still cry out from being restrainedor sometimes from the pain of the tap because the topical anesthetic wasnot completely effective or the needle tip touched the petrous bone--midazolamdoes not blunt pain receptors. But the child either has no memory of theprocedure or dissociates pain or anxiety from the visit despite some nebulousrecollection of the tap. We have witnessed only rare mild adverse reactions(less than 1% emergence delirium) and virtually no serious reactions. Mostimportant, at the follow-up visit after the procedure, the child nearlyalways greets us with the same degree of playfulness and cordiality (or,rarely, apprehension) as before the procedure.
Flumazenil (Romazicon) reverses the effects of midazolam. It must beavailable in the unlikely event that the patient develops signs of hypoventilation,cardiac suppression, or oversedation. Flumazenil is administered intravenouslyat 10 mg/kg per dose every 30 to 60 seconds (to a maximum dose of 1 mg)until reversal of sedation is achieved.
Attempts to prevent the lancing pain of myringotomy should be consideredworthwhile. Table 4 lists available topical anesthetics. Their efficacyis not uniformly reliable. My preference is to use the more expensive, custom-concocted8% tetracaine with a Pope Otowick. It has been highly effective if usedat least 30 minutes before the procedure. But we have observed one caseof a local reaction consisting of transient erythema and pruritis on andaround the ear.
Otolaryngologists report that touching the TM with the tip of a phenol-soakedswab produces excellent anesthestic results and an obvious myringotomy target(the site turns white).21 Some authors have advocated EMLA cream,but ensuring uniform contact of the thick cream with the TM has been problematic.
Some authors contend that using topical anesthetics may impede bacterialrecovery. We have experienced no notable microbiologic losses, however.Our annual bacterial recovery rate is 87%.
The pathogen recovery rate from middle ear aspirates is critically dependenton technique. Recovery rates as high as 87% to 91% have been observed inAOM by TPC when solid culture media is used and meticulous technique isapplied.7,22 Aspirated material must be carefully and quicklycultured by standard bacteriologic methods.
I highly recommend immediate inoculation of the aspirated material ontoboth 5% sheep blood and chocolate agar plates (shown above) and rapid placementin an incubator for growth overnight, preferably after first placing theplates in a candle jar or CO2 bag. Microbiologists contend thatmany organisms, particularly pneumococcus, perish when the aspirates areinoculated into transport media and allowed to incubate at room temperaturefor an extended period.23 Using these procedures, we have evenbeen able to recover pathogens from about half of children who have receivedantibiotics the same day as TPC.
Pediatricians inexperienced with TPC might want to observe the procedureor a pressure-equalizing tube insertion performed by an experienced pediatricianor an otolaryngologist respectively before performing TPC themselves. Thisshould familiarize them with the local landmarks and orientation for theneedle puncture.
They also might want to obtain a reading with an acoustic reflectometer(EarCheck PRO) before proceeding with TPC. Even experienced investigatorsoccasionally overestimate the presence of purulent material behind the TM.A normal reading by the acoustic reflectometry device usually predicts anabsence of fluid. (For more information on the use of this device, see theaccompanying article, "Three technologies for taming otitis media"starting on page 78.) If only one TM is severely infected and the otheris only mildly infected, I find it beneficial to aspirate the contralateralTM, which will otherwise often progress to a severely bulging TM.
If a minimal amount of material is aspirated from the middle ear andremains in the hub or the tubing, 0.5 mL of nonbacteriostatic saline canbe aspirated through the needle into the trap. I advocate aspirating salineafter every TPC because it theoretically lyses the leukocytes, which improvesrecovery of pathogens, and maximizes the volume of aspirate.
Using alcohol to sterilize the auditory canal is somewhat controversial.20If alcohol is used, it can be flushed out with nonbacteriostatic salineor allowed to evaporate, or the excess can be suctioned out before TPC toavoid aspirating it and subsequently sterilizing the middle ear specimen.
We avoid instilling topical antimicrobial preparations routinely afterTPC. They do not improve outcome--the TM usually seals over in 24 to 48hours anyway--and only add an unnecessary expense and the risk of drug hypersensitization.Topical antimicrobials may be useful in the following two situations, however:
We use CPT codes 69420 and 69420.50 to bill for unilateral and bilateralTPC, respectively. Preauthorization is often required but rarely denied.Our reimbursement for unilateral TPC ranges from $50 to $110 for a $110charge, and reimbursement for bilateral TPC ranges from $52 to $175 fora $175 charge. In some areas, reimbursement may be as high as $250 to $300.Conscious sedation is billed under CPT code 99142 at $25 to $60 dependingon the volume of midazolam administered, with compensation varying from$0 to $40. Under the Clinical Laboratory Improvement Acts, each culture,which costs around $50 to $100, is billed to the insurance carrier or, sometimesin our practice, to the investigative protocol.
TPC is rarely reimbursed under capitated payer systems. Nevertheless,as with septic evaluation of the febrile infant, lack of profitability shouldnot deter the pediatrician from performing the procedure. Moreover, we surmisethat it may prevent a significant proportion of children from undergoinginsertion of pressure-equalizing tubes, particularly if they are not otitisprone. Our annual rate of pressure-equalizing tube placement is only 2%and 6% in the first and second years of life, respectively. In many plans,this may be especially cost-effective for the primary care physician.
As the renowned otolaryngologist Michael Poole, MD, recommended in 1994,"It's time to bring back diagnostic tympanocentesis."7We have been performing this procedure for over two decades in our office.Even before the advent of multiple-drug-resistant middle ear pathogens,we found it to be extremely worthwhile for alleviating acute ear pain, drainingchronic abscess-like refractory AOM, and identifying the pathogen causingeither refractory AOM or invasive disease in the febrile, ill child. AlthoughTPC is not risk-free, our group and other experienced otoscopists nationwidehave never encountered a serious problem from the procedure.
Administering the mild oral sedative midazolam with its anxiolytic andamnestic effects has removed the pre- and post-procedure anxiety that weformerly encountered in children. Sedating the child allays anxiety forboth the family and the pediatrician. As long as no other CNS depressantshave been administered recently, midazolam is remarkably safe. We have alsofound a highly effective way to anesthetize the TM with topical tetracaineand an Otowick.
Robert Hoekelman, MD, asked pediatricians in the title of his 1991 articlein Pediatric Annals, "Do you do tympanocentesis?"24Leading pediatric infectious disease specialists are ardently advocatingits use for more cases of AOM. The procedure is easy to learn and perform,and most of the necessary equipment is readily available in the pediatrician'soffice. To help pediatricians get started, a course entitled "Improvingoutcomes in acute otitis media management" is to be offered this yearin several large metropolitan areas. Organized by Michael Pichichero, MD,the course teaches the benefits and mechanics of performing tympanocentesisin the office. For information about workshops in your area, call 877-EAR-OMEW(toll free).
The reasons for pediatricians to use TPC have not been more compellingsince the advent of antibiotics. Nor has it ever been possible to performthe procedure so humanely. Every pediatric adacemic center should routinelyteach TPC. Most pediatricians should add it to their therapeutic armamentariumin this era of resistant pneumococcus.
THE AUTHOR is in private practice at Physicians to Children and Adolescentsand is President of Kentucky Pediatric Research, Inc., Bardstown, KY. Heis Associate Clinical Professor of Pediatrics at the University of Louisville,Louisville, KY, and the University of Lexington, Lexington, KY. He has receivedresearch support from MDI Instruments and is participating in a clinicaltrial for an antiviral study with Roche Pharmaceuticals.
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