Managing otitis media: a time for change.

Given the increasing prevalence of multiply resistant pneumococcal infection and the heightened risks associated with antimicrobial usage, antimicrobial treatment of otitis media in children should be restricted generally to the extent possible without compromising individual children's well-being and without subjecting them to risks potentially greater than the risks associated with antimicrobial usage. Not infrequently the decisions required will be difficult and matters of judgment. However, in most cases the indications for initiating or prolonging antimicrobial treatment will be either straightforward, calling for a decision to proceed, or marginal, in which case the decision not to proceed should be clear.

Evidence in infants with cleft palate that breast milk protects against otitis media.

OBJECTIVE: Most infants with cleft palate suckle unproductively and require feeding by artificial means. Most also have unremitting otitis media accompanied by (usually) nonpurulent middle-ear effusion, a complication generally attributed to impaired eustachian tube ventilatory function. We observed two infants with cleft palate in whom one or both ears appeared effusion-free on more than one occasion, and who also were receiving or previously had received breast milk feedings. This prompted us to analyze the relation between middle-ear status and feeding mode in a large series of infants with cleft palate. Our objective was to determine whether in these infants the receipt of breast milk mitigated the otherwise virtually invariable development and continued presence of otitis media. METHODS: We reviewed and analyzed data concerning both feeding mode and the presence or absence of middle-ear effusion in 315 infants with cleft palate, as recorded systematically in the course of prospective studies at our Cleft Palate-Craniofacial Center. Analysis was limited to periods preceding the infants' receipt of tympanostomy-tube placement or palate repair, or their second birthday, whichever occurred first. RESULTS: Freedom from effusion in one or both ears was found at one or more visits in only seven (2.7%) of 261 infants fed cow's milk or soy formula exclusively, but in 17 (32%) of 54 infants fed breast milk exclusively or in part for varying periods (P < .0001). In virtually all instances, the breast milk had been harvested by the mother and fed to the infant via an artificial feeder. Baseline clinical and sociodemographic characteristics and surveillance in the two groups of infants were comparable. CONCLUSIONS: Artificially fed breast milk provides variable protection against the development of otitis media in infants with cleft palate. This finding supports the likelihood of a similarly protective effect of breast milk in noncleft infants. The finding also suggests strongly that in infants with cleft palate, impaired eustachian tube function is not the only pathogenetic factor in the infants' initial development of middle-ear effusion.

Odor perception in children in relation to nasal obstruction.

To determine whether nasal obstruction in children results in impaired nasal function, olfactory sensitivity was assessed in 65 children with various degrees of nasal obstruction and in 13 children without nasal obstruction. Overall, olfactory detection thresholds were directly related to clinical ratings of degree of nasal obstruction. Of the subjects with nasal obstruction attributable to adenoid hypertrophy, 28 received adenoidectomy; when retested 2 to 28 months later, 20 of the 28 subjects showed generally commensurate reductions in nasal obstruction ratings and olfactory detection thresholds. In a comparison subgroup of 16 subjects retested after intervals of 5 to 13 months without having received intervening adenoidectomy, both the nasal obstruction ratings and the olfactory detection thresholds remained relatively unchanged. These results suggest that, in children, nasal obstruction of varied degree is associated with commensurate impairment of the ability to smell, and that reduction in the degree of nasal obstruction results in commensurate recovery of the ability to smell. Olfactory function, although hitherto accorded little pediatric attention, deserves consideration both in weighing the importance of nasal obstruction in children and in deciding about therapeutic intervention.

Modified schema for classifying positive-pressure tympanograms.

Tympanograms with peaks located in the high-positive air pressure range (greater than or equal to 50 mm H2O) are infrequently recorded in clinical practice and have been little discussed in the literature. Such tympanograms accounted for 1.2% of a series of 8,011 tympanograms recorded at various times from 1,556 subjects ranging in age from 7 months through 12 years. Correlations between otoscopic diagnoses and tympanometric findings in the case of 65 of the high-positive air pressure tympanograms form the basis of the present report. Of the 65 high-positive air pressure tympanograms, 51 showed relatively high compliance (less than or equal to 5.5 Madsen units), and of these 46 (90%) were associated with ears considered normal otoscopically. Fourteen of the high-positive air pressure tympanograms showed low compliance (greater than 5.5 Madsen units), and of these, six (43%) were associated with ears considered normal, six (43%) with ears showing signs of acute infection, and two (14%) with ears in which the presence of effusion seemed probable. A previously presented zonal schema for classifying tympanograms has been modified on the basis of these findings.

Tympanometric detection of middle ear effusion in infants and young children.

Tympanometry, a test of middle ear status new to clinical pediatrics, was carried out on 280 subjects, 10 days through 5 years of age. The tympanograms obtained were compared with otoscopic findings and, in 107 of the subjects, with findings at myringotomy. Seven distinct tympanometric curve types were identified and defined, based on their degree of correlation with the presence or absence of middle ear effusion. In subjects 7 months of age and older, curves suggesting normal (high) tympanic membrane compliance in combination with atmospheric or near-atmospheric middle ear air pressure were rarely associated with effusion. Conversely, curves suggesting low tympanic membrane compliance were highly correlated with the presence of effusion. Curves suggesting intermediate compliance or reduced middle ear air pressure were also correlated with effusion, but the degree of correlation was dependent on the shape of the curve. In infants less than 7 months of age, many of the ears with effusion had "normal" tympanograms, presumably because external auditory canal walls in such infants tend to be highly distensible. Tympanometry is a simple, rapid, atraumatic, valid, and objective test, easily administered by paraprofessional personnel. Its use can result in improved detection of middle ear effusion and other middle ear abnormalities, and also appears to promote improvement in diagnostic acumen.

Acute otitis media in children with bronchiolitis.

OBJECTIVE: We investigated the prevalence and the etiology of acute otitis media (AOM) in children with bronchiolitis to determine whether AOM in such children is due entirely or mainly to respiratory syncytial virus (RSV), in which case routine antimicrobial treatment would not be appropriate. METHODS: The study group consisted of children aged 2 to 24 months with bronchiolitis. In patients with AOM at entry, nasal washings for RSV enzyme-linked immunosorbent assay were obtained, and Gram-stained smear, bacterial culture, and reverse transcriptase polymerase chain reaction to detect the presence of RSV were performed on middle-ear aspirates. Patients without AOM were reevaluated at 48 to 72 hours, 8 to 10 days, and 18 to 22 days. RESULTS: Forty-two children with bronchiolitis were enrolled. Sixty-two percent had AOM at entry or developed AOM within 10 days. An additional 24% had or eventually developed otitis media with effusion. Only 14% remained free of both AOM and otitis media with effusion throughout the 3-week observation period. All patients with AOM had 1 or more bacterial pathogens isolated from one or both middle-ear aspirates. Of 33 middle-ear aspirates, Streptococcus pneumoniae was isolated in 15, Haemophilus influenzae in 8, Moraxella catarrhalis in 8, and Staphylococcus aureus in 2. Two middle-ear aspirates yielded 2 pathogens each; 2 aspirates had no growth. RSV was identified in 17 (71%) of 24 patients with AOM. CONCLUSION: Bacterial AOM is a complication in most children with bronchiolitis. Accordingly, in patients with bronchiolitis and associated AOM, antimicrobial treatment is indicated.

Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial.

A total of 536 infants and children with acute otitis media were randomly assigned to one of six consistent year-long regimens involving the treatment of nonsevere episodes with either amoxicillin or placebo, and severe episodes with either amoxicillin, amoxicillin and myringotomy, or, in children aged 2 years or older, placebo and myringotomy. Nonsevere episodes had more favorable outcomes in subjects assigned to treatment with amoxicillin than with placebo, as measured by the proportions that resulted in initial treatment failure (3.9% vs 7.7%, P = .009) and the proportions in which middle-ear effusion was present at 2 and 6 weeks after onset (46.9% vs 62.5%, P less than .001; and 45.9% vs 51.5%, P = .09, respectively). In subjects whose entry episode was non-severe, those assigned to amoxicillin treatment had less average time with effusion during the succeeding year than those assigned to placebo treatment (36.0% vs 44.4%, P = .004), but recurrence rates of acute otitis media in the two groups were similar. In the 2-year-and-older age group, severe episodes resulted in more initial treatment failures in subjects assigned to receive myringotomy alone than in subjects assigned to receive amoxicillin with, or without, myringotomy (23.5% vs 3.1% vs 4.1%, P = .006). In the study population as a whole, severe episodes in subjects assigned to receive amoxicillin alone, and amoxicillin with myringotomy, had comparable outcomes. It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug). The data provide no support for the routine use of myringotomy either alone or adjunctively.

Treatment guidelines for otitis media: the need for breadth and flexibility.

The recent issuance of guidelines for the diagnosis and treatment of otitis media with effusion in young children is an effort to provide direction for the practitioner in managing this common condition. Although the guidelines may often prove helpful, practitioners will need to maintain some degree of flexibility in dealing with patients both with acute otitis media and with otitis media with effusion, based on specific patient-related and disease-related factors.

Otitis media and child development: should we worry?

Persistent middle ear effusion in infancy and early childhood has been blamed for impairments of speech, language, cognition and psychosocial development later in life. Whether that blame is justified remains unresolved and a matter of controversy, because studies of the relationships involved have been limited and often contradictory and because none was designed so as to address the issue of causality. At issue in particular is the common practice of subjecting infants and young children with persistent otitis media with effusion (OME) to tympanostomy tube placement specifically to reduce the risk of developmental impairment. Currently children younger than age 3 years undergo an estimated 313000 tympanostomy tube placement operations per year, at a cost of about $750 million. If a causal association between early life OME and later developmental impairment were to be established, answers would also be needed to the questions whether the adverse effects of OME are linear or threshold, whether they are permanent or transient and whether they are preventable by timely tube placement. A prospective study designed to address all of these questions is currently under way at Children's Hospital of Pittsburgh. The study involves enrolling a large, demographically diverse sample of normal infants before 2 months of age; monitoring them for the presence or absence of otitis media throughout the first 3 years of life; identifying those in whom OME has persisted for specified minimum periods; randomly assigning those subjects either to prompt tube placement or to delayed tube placement if OME persists; and administering a battery of standardized developmental tests to those subjects and to a sample of the others at ages 3, 4 and 6 years. Details of the study design and procedures are described in this report.

Controversy over tubes and adenoidectomy.

Dr. Bluestone then summarized the panelists' discussion by stating that there is now evidence that myringotomy alone for chronic otitis media with effusion has some efficacy but is probably no better than watching the child and not performing surgery. He also stated there are now some data to show that myringotomy and tube insertion for chronic otitis media with effusion appear to be more beneficial than either watching a child over a long period of time or performing myringotomy alone. However, the panelists made a plea that each child should be individualized on the basis of the duration of the effusion, the child's response to medication, the time of the year, distance from health care providers and other factors. Dr. Gates stressed that hearing loss was an important factor, but if hearing loss is a deciding factor, then serial audiograms or at least some assessment of hearing in the clinician's office should be performed. He also stated that there is now evidence that adenoidectomy is effective in certain children, but there is still an 80% recurrence rate and a 15% rate of failure in which children require repeat surgery. Dr. Bluestone suggested that parents and the child (if old enough) should be informed of what is known about the risks, costs and benefits of these surgical procedures. He recommended the clinician discuss with the parents the pros and cons of performing or not performing surgery, including the complications and sequelae of otitis media and also of tube insertion.(ABSTRACT TRUNCATED AT 250 WORDS)

Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion.

In a previous trial involving 109 children with chronic otitis media with effusion of at least a 2 months' duration that had been unresponsive to medical treatment, we compared the efficacy of myringotomy with tube insertion, myringotomy alone and no surgical intervention with regard to time with middle ear effusion, hearing status and other indices over a 3-year period. Because interpretation of the results was rendered difficult by certain complexities of study design, the present trial with a revised protocol was carried out in an additional group of 111 children. As in the previous trial, myringotomy with tube insertion resulted in less time with effusion and better hearing than did either myringotomy alone or no surgery. However, acute and chronic otorrhea and tympanic membrane perforation developed not uncommonly after tube insertion. Myringotomy alone offered no advantage over no surgery regarding the percent of time with effusion or the number of episodes of acute otitis media. Currently for children with long-standing middle ear effusion, we recommend either watchful waiting with periodic hearing assessment or myringotomy with tube insertion, individualizing the recommendation for each child.

Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children.

We randomly assigned children with otitis media with effusion to receive either erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for a 2-week period, primarily to determine whether either erythromycin-sulfisoxazole or cefaclor would have greater short term efficacy than that found previously for amoxicillin, and secondarily to supplement earlier data on outcomes in placebo-treated subjects. Interim analyses showed no statistically significant (P less than 0.05) differences between the three antimicrobial treatment groups in the primary outcome measures, i.e. the prevalence of middle-ear effusion 2 and 4 weeks after entry, and indicated that postulated differences favoring the erythromycin-sulfisoxazole and cefaclor groups over the amoxicillin group were unlikely to be found even if the originally calculated sample size were attained. Subject accrual was therefore terminated. Final analysis showed no significant between-group differences in other outcome measures as well. In antimicrobial vs. placebo comparisons neither erythromycin-sulfisoxazole nor cefaclor gave more favorable outcomes than placebo, whereas more children were effusion-free in the amoxicillin group than in the placebo group at 2 weeks (31.6% vs. 14.1%, P = 0.007), but not at 4 weeks. We conclude that when antimicrobial treatment for otitis media with effusion is deemed advisable, neither erythromycin-sulfisoxazole nor cefaclor should replace amoxicillin as first line treatment.

Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial.

To determine the efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion in preventing recurrences of acute otitis media, we randomized 264 children 7 to 35 months of age who had a history of recurrent otitis media but were free of middle ear effusion to receive either amoxicillin prophylaxis, bilateral tympanostomy tube insertion or placebo. The average rate of new episodes per child year of either acute otitis media or otorrhea was 0.60 in the amoxicillin group, 1.08 in the placebo group and 1.02 in the tympanostomy tube group (amoxicillin vs. placebo, P less than 0.001; tubes vs. placebo, P = 0.25). The average proportion of time with otitis media of any type was 10.0% in the amoxicillin group, 15.0% in the placebo group and 6.6% in the tympanostomy tube group (amoxicillin vs. placebo, P = 0.03; tubes vs. placebo, P less than 0.001). At the 2-year end point, the rate of attrition was 42.2% in the amoxicillin group, 45.5% in the placebo group and 26.7% in the tympanostomy tube group. Adverse drug reactions occurred in 7.0% of the amoxicillin group and persistent tympanic membrane perforations developed in 3.9% of the tympanostomy tube group. The observed degree of efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion must be viewed in light of the fact that study subjects proved not to have been at as high risk for acute otitis media as had been anticipated and in view of the differential attrition rates.(ABSTRACT TRUNCATED AT 250 WORDS)

Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of amoxicillin/clavulanate potassium (Augmentin) for treatment of acute otitis media in children.

OBJECTIVE: To compare the safety and efficacy, in treating acute otitis media (AOM) in children, of a new formulation of amoxicillin/clavulanate potassium (Augmentin) oral suspension providing 45/6.4 mg/kg/day and administered twice daily (bid) for 5 and 10 days, respectively, with the safety and efficacy of the original formulation providing 40/10 mg/kg/day and administered three times daily (tid) for 10 days. STUDY DESIGN: Eight hundred sixty-eight children ages 2 months to 12 years with AOM were randomly assigned to one of the three treatment groups. Stringent criteria were used for the diagnosis of AOM and for determinations of "cure" and "improvement." Subjects were reexamined on Days 12 to 14 and 32 to 38. RESULTS: Among subjects whose treatment and follow-up conformed fully to protocol, the proportion of treatment successes (clinically cured or improved) on Days 12 to 14 was 78.8% (149 of 189) in the tid 10-day group, 86.5% (154 of 178) in the bid 10-day group and 71.1% (140 of 197) in the bid 5-day group. Corresponding values on Days 32 to 38 were 64.2% (95 of 148) in the tid 10-day group, 63.1% (94 of 149) in the bid 10-day group and 57.8% (93 of 161) in the bid 5-day group. None of the differences between the tid 10-day regimen and either of the 2 bid regimens were statistically significant, but the bid 10-day regimen was significantly more effective than the bid 5-day regimen in younger subjects. In the study population as a whole, results were similar to those in per protocol subjects. Overall the incidence of protocol-defined diarrhea was 26.7% (74 of 277) in the tid 10-day group, compared with 9.6% (27 of 280) in the bid 10-day group (P < 0.0001) and 8.7% (25 of 286) in the bid 5-day group (P < 0.0001). CONCLUSIONS: In comparison with the original formulation of Augmentin administered tid for 10 days in the treatment of AOM in children, the new formulation administered bid for 10 days provides at least equivalent efficacy and causes substantially less diarrhea. Administration for 5 days appears not to provide equivalent efficacy, but the difference appears limited to younger children and the margin of difference is small.

Efficacy of Auralgan for treating ear pain in children with acute otitis media.

OBJECTIVE: To determine the efficacy of Auralgan otic solution (combination product of antipyrine, benzocaine, and glycerin) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media (AOM). DESIGN: Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were randomly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s) of the affected ear(s). All children were also treated with 15 mg/kg of acetaminophen in a single dose. Ear pain was assessed by means of 2 visual analog seales-a linear scale and a color scale-at study entry and 10, 20, and 30 minutes later (T0, T10, T20, and T30, respectively). Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score. A baseline ear pain score of at least 3 points was required for study entry. Four outcome measures regarding ear pain score at T10, T20, and T30 were used: (1) proportion of subjects who showed 50% reduction, (2) proportion of subjects who showed 25% reduction, (3) proportion of subjects who showed a 1 or more point reduction, and (4) mean score over time. SETTING: Primary care center and emergency department of a children's hospital. PARTICIPANTS: Fifty-four children aged 5 to 19 years with ear pain and AOM. RESULTS: The Auralgan and placebo groups were comparable regarding age, sex, race, laterality of AOM, and T0 ear pain score. By each of the 4 measures used, the response to treatment consistently favored the Auralgan group, but only at T30 were any differences statistically significant. CONCLUSION: In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes.

Myringotomy with and without tympanostomy tubes for chronic otitis media with effusion.

We studied 109 children with otitis media with effusion of 2 months' duration or longer that was unresponsive to medical management. Eighty-six subjects who had neither "significant" hearing loss nor defined symptoms were randomly assigned to receive myringotomy, myringotomy with tympanostomy tube insertion, or no surgery, and 23 subjects with significant hearing loss, defined symptoms, or both were randomly assigned to receive either myringotomy or myringotomy with tube insertion. Myringotomy with tube insertion provided more disease-free time and better hearing than either myringotomy alone or no surgery; however, some subjects who underwent myringotomy with tube insertion developed otorrhea or persistent perforation of the tympanic membrane. Myringotomy offered no advantage over no surgery regarding percent of time with middle-ear effusion, number of acute otitis media episodes, and number of subsequent surgical procedures. These results may not properly be extrapolated to less severely affected children.

Pediatrician's view of middle ear effusions: more questions than answers.

Although middle ear effusion is the most common of the chronic conditions encountered in pediatric practice, it frequently goes unrecognized, and relatively little is known about its epidemiology or its natural history. More importantly, the impact of middle ear effusion on the overall well-being of infants and children, and on their cognitive and language development, remains essentially unexplored. In part because of these gaps in our knowledge, and also because prospective, controlled treatment trials have not been reported, uncertainty and controversy exist concerning: 1) the necessity, in many instances, of treating middle ear effusion; 2) the choice of various treatment methods; and 3) the timing of those treatments that are undertaken. Finally, the widespread use of adenoidectomy to prevent middle ear inflammation is seriously lacking in supporting evidence. A few reported studies bear on some of these questions, but both their scope and the information they provide are limited. In order to resolve important prognostic and treatment issues concerning middle ear effusion during infancy and childhood, carefully designed epidemiologic and clinical studies of types not hitherto reported are urgently needed.

Management of middle ear effusions in infants with cleft palate.

Middle ear effusion is now generally recognized as a virtually universal complication in infants with cleft palate. Such infants may therefore be assumed to experience conductive hearing loss of some degree or other throughout infancy. Hoping to prevent not only deficits in intellectual and language development, but also permanent otic and auditory handicaps, we have routinely treated such infants as early as practicable with myringotomy and tympanostomy tube insertion. Subsequently, we have repeated the operation whenever blockage or extrusion of the tubes resulted in recurrence of persistent effusion. In this manner we have been able to maintain most infants in satisfactory middle ear status most of the time. Otorrhea, however, has been a frequent complication. Preliminary findings suggest that infants managed according to this regimen may eventually develop better language function than those not receiving such management. A current study is designed to test the advantages and disadvantages that might result from deferring the initial routine myringotomy until somewhate later in infancy.

Impedance screening for preschool children. State of the art.

As a test for detecting middle ear disease among preschool children, tympanometry -- as opposed to audiometry -- has three advantageous attributes: a high degree of sensitivity, minimal need for subject cooperation, and total objectivity. For these reasons interest has arisen in tympanometry as a method for screening, i.e., identifying children with previously undetected middle ear disease. However, uncertainty persists concerning the importance of detecting apparently asymptomatic middle ear effusions, and concerning optimal methods, or even the advisability, of treating them. Further, the sensitivity and specificity of tympanometry depend on how the pass-fail cutoff point is defined. Defining this cutoff point so as to achieve high sensitivity may result in excessively low specificity, with the production of large numbers of false-positives who then become overreferrals. Data are presented to show how the validity of the test may be increased to some extent by attention to the gradient of "negative-pressure" tympanograms. At the present time, given the various aforementioned uncertainties, and with adequate validation as to the presence or absence of disease often lacking in reported studies of impedance screening in preschool populations, the cumulative results of these studies do not warrant embarking on large-scale screening programs. What is needed instead is additional research to explore the issue further.

Sinus histiocytosis with massive lymphadenopathy. Report of its occurrence in two siblings with retropharyngeal involvement in both.

Sinus histiocytosis with massive lymphadenopathy (SHML) was found in two siblings, both of whom had retropharyngeal involvement. In one of the children the retropharyngeal swelling appeared to produce obstructive symptoms, requiring excision of the involved lymph nodes. These cases appear to constitute not only the first proven familial occurrence of SHML but also the only reported instances of retropharyngeal involvement. SHML is an uncommon disease of unknown etiology that must be distinguished from other diseases associated with marked lymphadenopathy, particularly as its course is generally benign and not altered by any known form of medical treatment.