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.

Efficacy of 20- versus 10-day antimicrobial treatment for acute otitis media.

OBJECTIVE: The purpose of this trial was to determine whether 20 days of antimicrobial treatment is more efficacious than 10 days of treatment for acute otitis media (AOM) in clearing middle ear effusion and preventing recurrences of AOM, and whether changing to a beta-lactamase-stable antimicrobial agent after the initial 10-day treatment with amoxicillin for AOM is advantageous. METHODS: Children between 7 months and 12 years of age with AOM were randomly assigned to three treatment groups: (1) amoxicillin for days 1 through 10, then amoxicillin for days 11 through 20; (2) amoxicillin for days 1 through 10, then amoxicillin-clavulanate for days 11 through 20; and (3) amoxicillin for days 1 through 10, then a placebo for either amoxicillin or amoxicillin-clavulanate for days 11 through 20. Medication was dispensed in a double-blind manner. Children underwent tympanocentesis at entry and were re-examined on days 10, 20, 30, 60, and 90 after entry. RESULTS: Two hundred sixty-seven children entered the trial. At the 20-day visit, the percentages of children who were effusion free in the amoxicillin, amoxicillin-clavulanate, and placebo groups were 72.4%, 80.8%, and 52.5%, respectively. There was no statistically significant difference in the percentage of children who were effusion free between the amoxicillin and amoxicillin-clavulanate groups (95% confidence interval, -21.7, 4.9). Subsequent to the day 10 visit, the average proportions of time with middle ear effusion were not significantly different in the amoxicillin, amoxicillin-clavulanate, and placebo groups (0.29, 0.27, and 0.34, respectively), nor were there significant differences in the rates of recurrent episodes of AOM (0.56, 0.59, and 0.68, respectively). Regardless of treatment group, approximately 75% of children were effusion free at the time of their last visit. CONCLUSIONS: More children were effusion free by the day 20 visit if given antimicrobial treatment for 20 days rather than for 10 days, but this advantage was present for only a short time; by the end of the 90-day study period, the treatment groups were comparable with regard to effusion status. Recurrence of AOM during the study period was not prevented by the additional 10 days of treatment. Routine use of an additional 10-day course of antimicrobial treatment is therefore not recommended if a child is symptom free after the initial 10 days of treatment for AOM.

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.

Otitis media and sinusitis in children. Role of Branhamella catarrhalis.

Otitis media and sinusitis are among the most common diseases of childhood and various treatment approaches have been advocated. This review focuses on current experience in Pittsburgh, both in terms of our methods of patient management and the changing aetiology of the underlying diseases. Special reference is made to the role played by Branhamella catarrhalis and the emergence of beta-lactamase-producing strains. Results from recently completed clinical trials would suggest that antibacterial therapy should be administered to children with these infections, to reduce morbidity and prevent the ever-present supportive complications associated with both diseases.

Management of otitis media in infants and children: current role of old and new antimicrobial agents.

Otitis media, the diagnosis most frequently made by the pediatrician, is most effectively treated with antimicrobial therapy. Amoxicillin (or ampicillin) has been the standard for infants and children with acute otitis media because it is safe and effective for most of the causative bacterial pathogens. Amoxicillin has also been shown to be effective for treatment of some children with otitis media with effusion ("secretory" otitis media) and is the recommended prophylactic antimicrobial agent for prevention of frequently recurrent acute otitis media. However, during the past decade there has been an increasing rate of bacteria that are resistant to amoxicillin, primarily beta-lactamase-producing Haemophilus influenzae and Branhamella catarrhalis. Because of the emergence of these bacteria, other antimicrobial agents both old and new have been advocated for treatment and prevention of otitis media; amoxicillin-clavulanate and cefuroxime axetil are the newer agents. These agents are indicated for selected infants and children but for most patients amoxicillin remains a safe and relatively inexpensive effective "old friend".

Otitis media and congenital perilymphatic fistula as a cause of sensorineural hearing loss in children.

In all infants and children who have progressive, fluctuating or sudden sensorineural hearing loss, the possibility of a congenital perilymphatic fistula should be considered. Factors determined to be highly suggestive of the presence of a congenital perilymphatic fistula as the cause of sensorineural hearing loss or vertigo, or both, include the following: mixed conductive and sensorineural hearing loss; antecedent sudden physical exertion or barotrauma; congenital deformities of the external ear and head; and abnormal findings on computed tomograms of the temporal bone, especially Mondini-like ear dysplasias. In a series of 37 children who had a congenital perilymphatic fistula treated at the Children's Hospital of Pittsburgh, 28 (76%) had had documented otitis media in the past or a history of middle ear disease. This finding should alert the clinician to the possibility of the presence of a congenital perilymphatic fistula when sensorineural hearing loss develops or progresses during an episode of otitis media. Perilymphatic fistula is caused by either congenital ossicular deformities or abnormalities of the labyrinthine windows or coexistence of both conditions. The likelihood of there being no further deterioration in hearing after surgical repair of a perilymphatic fistula is high. Every infant and child with unexplained hearing loss or disequilibrium or both deserves an attempt to uncover the cause at the earliest possible age.

Current management of chronic suppurative otitis media in infants and children.

Most children who have chronic suppurative otitis media require: (1) a thorough examination of the external canal and tympanic membrane with the otomicroscope (under general anesthesia, if necessary); (2) a Gram stain and culture obtained directly from the middle ear; (3) thorough aspiration of the ear canal and, if possible, the middle ear, i.e. "aural toilet"; (4) treatment with an orally administered antimicrobial agent and an ototopical medication, if the organisms are susceptible; and if the suppurative process is unresponsive to this management, hospitalization and the parenteral administration of an antimicrobial agent. Parenteral antimicrobial therapy should be selected following microbiologic assessment of the discharge. If the infection can be eliminated using the methods described above, prevention of recurrence can be achieved by the following options: (1) prophylactic antimicrobial therapy; (2) removal of the tympanostomy tube; or (3) surgical repair of the tympanic membrane defect. The choice of these options depends on the age of the child and the status of the function of the eustachian tube. Middle ear and mastoid surgery should be reserved for those children who fail to respond to intensive medical therapy.

Role of surgery for otitis media in the era of resistant bacteria.

Otitis media is currently the most common diagnosis made by clinicians, and its prevalence has an impact on managed health care. With the emergence of bacterial pathogens resistant to many antimicrobial agents, an urgent need exists to reassess the indications for surgical management of this more prevalent disease. In an effort to determine the causative bacterial etiology of acute otitis media, which may be resistant to commonly prescribed antimicrobial agents, tympanocentesis is indicated today more than ever, especially when patients fail to improve or worsen while receiving antibiotics (i.e. treatment failures). In an effort to reduce the use of antimicrobial agents, prophylactic administration of these drugs for prevention of recurrent otitis media should only be prescribed on an individualized basis, with myringotomy and tympanostomy tube insertion being a more reasonable alternative. Adenoidectomy should be also considered when moderate to severe nasal obstruction is present or when repeat tympanostomy tube placement is needed. Likewise when chronic otitis media with effusion is unresponsive to a trial of antimicrobial therapy, tympanostomy tube insertion, adenoidectomy or both procedures should be considered, as opposed to re-treating with a variety of antibiotics. The role of these surgical procedures has become more important today in this era of antibiotic-resistant bacteria. Also in our cost-conscious environment, it is uncertain which method of management is more expensive, surgery or prolonged medical management.

Efficacy of ofloxacin and other ototopical preparations for chronic suppurative otitis media in children.

The safety and efficacy of ototopical preparations, such as ofloxacin, in the treatment of CSOM in infants and children do not currently have approval by the FDA even though ofloxacin is FDA-approved for treatment of CSOM that occurs in adults. However, treatment with ofloxacin is FDA-approved when AOM occurs in children who have a tympanostomy tube in place, and effective treatment of this acute infection should prevent the subsequent development of CSOM.

Review of cefixime in the treatment of otitis media in infants and children.

During the past decade there has been an increase in the percentage of resistant bacteria isolated from middle-ear effusions aspirated from infants and children who have had acute otitis media. At least nine oral antibiotics or combination agents are available for this indication. Cefixime, a third generation cephalosporin, has excellent in vitro activity against both beta-lactamase-negative and beta-lactamase-positive Haemophilus influenzae and Moraxella catarrhalis, good activity against Streptococcus pneumoniae and Streptococcus pyogenes but relatively poor activity against Staphylococcus aureus. In children cefixime is similar in effectiveness to amoxicillin and cefaclor, but diarrhea and stool changes are more common with cefixime. Amoxicillin is still preferred for initial empiric treatment of uncomplicated acute otitis media. Its major drawback is limited efficacy when beta-lactamase-producing bacteria are the causative organisms. Cefixime is a viable alternative to amoxicillin for infants and children with acute otitis media when: (1) a beta-lactamase-producing H. influenzae or M. catarrhalis is isolated from otorrhea or tympanocentesis; (2) the child has a history of delayed hypersensitivity to the penicillins but no history of hypersensitivity to the cephalosporins; (3) there is a high incidence of resistant bacteria in the community; (4) there is not clinical improvement with amoxicillin; or (5) once daily administration is more convenient.

Ten-year review of otitis media pathogens.

Data collected from 1980 to 1989 by investigators at the Pittsburgh Otitis Media Research Center were examined to detect changes over time in the prevalence of bacteria isolated from middle ear effusions in patients with otitis media. The organisms isolated most commonly from the 7396 effusions cultured at the center were Streptococcus pneumoniae and Haemophilus influenzae. S. pneumoniae predominated in the subgroup of patients with acute otitis media, whereas H. influenzae was isolated most frequently from patients with otitis media with effusion. The most notable changes to occur during the 10-year period were a statistically significant increase in the prevalence of S. pneumoniae in patients with acute otitis media and a progressive rise in the percentage of beta-lactamase-producing strains of H. influenzae and Moraxella (Branhamella) catarrhalis. The latter finding suggests the need for therapeutic alternatives to amoxicillin, which is not active against beta-lactamase-producing organisms, when these organisms are suspected or cultured from the middle ear.

A comparative evaluation of cefaclor and amoxicillin in the treatment of acute otitis media.

In an earlier study of 214 children with acute otitis media (AOM) randomly assigned to a 14-day course of either cefaclor or amoxicillin, 55.7% of cefaclor-treated subjects were effusion-free compared with 41.2% of amoxicillin-treated subjects at the end of treatment. The present study was conducted to determine whether, in a 1-year period, subjects treated with cefaclor for each episode would have middle ear effusion for significantly less time than those treated with amoxicillin for each episode. One hundred fifty-seven subjects with AOM were enrolled. No statistically significant differences were found between the cefaclor-treated and amoxicillin-treated groups in number of subjects effusion-free immediately after first treatment (47.9% vs. 42.3%, respectively), average percent of time with effusion (22.2% vs. 23.4%, respectively), or in rate of new episodes of AOM (3.05 vs. 3.26, respectively). We conclude that there is no clinically significant advantage to the use of cefaclor rather than amoxicillin as the routine first line drug in the treatment of AOM.

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.

Efficacy of antimicrobial prophylaxis for recurrent middle ear effusion.

OBJECTIVES: This trial compared the efficacy of amoxicillin prophylaxis with that of placebo for the management of recurrent middle ear effusion (MEE) in children. METHODS: Children between 7 months and 12 years of age who were effusion-free at entry but had histories of chronic or recurrent MEE were randomly assigned to receive either amoxicillin (20 mg/kg once daily) or placebo for 1 year. They were examined monthly and when there were symptoms of ear, nose or throat disease. Acute otitis media (AOM) and new episodes of otitis media with effusion (OME) were treated with amoxicillin-clavulanate; tympanocentesis was performed when possible for episodes of AOM. Throat cultures were obtained at entry; 4, 8 and 12 months after entry; and with new episodes of AOM and OME. Tympanometry was performed at each visit and audiometry was performed at entry and 4, 8 and 12 months after entry. RESULTS: One hundred eleven children were entered in this study. The rates per person year of new episodes of disease in the amoxicillin and placebo groups, respectively, were: MEE, 1.81 vs. 3.18 (P < 0.001); AOM, 0.28 vs. 1.04 (P < 0.001); and OME, 1.53 vs. 2.15 (P = 0.016). Subjects in the amoxicillin group had less time with MEE than the placebo group (19.7 and 33.2%, respectively; P = 0.002). Middle ear and throat cultures did not reveal any increase in beta-lactamase-producing organisms or in Streptococcus pneumoniae attributable to daily use of amoxicillin. CONCLUSIONS: Amoxicillin prophylaxis lowered the rates of occurrence of MEE, AOM and OME and decreased the percentage of time with MEE. However, because of present day concerns regarding antibiotic resistance, management should be individualized.

Efficacy of ceftibuten compared with amoxicillin for otitis media with effusion in infants and children.

OBJECTIVES: This trial compared the efficacy of ceftibuten with that of amoxicillin in resolving otitis media with effusion. METHODS: Two hundred ten children with otitis media with effusion were randomly assigned to receive either ceftibuten (9 mg/kg/day in one daily dose) or amoxicillin (40 mg/kg/day divided into 3 daily doses) for 14 days. Outcome was assessed at 2 and 4 weeks in all subjects; those without middle ear effusion at the 4-week visit were examined at 8, 12 and 16 weeks. Middle ear status was determined by pneumatic otoscopy and by an algorithm combining pneumatic otoscopy with tympanometry. RESULTS: The percentages of subjects who were effusion-free in the ceftibuten and amoxicillin groups at 2 weeks by otoscopy were 29.8 and 27.2%, respectively (P = 0.59), and by the algorithm, 23.4 and 20.4%, respectively (P = 0.47). In children who were effusion-free at 2 weeks, recurrence of effusion by 16 weeks was noted in approximately 60% of the ceftibuten group and 67% of the amoxicillin group. No medication side effects were reported by 88% of subjects in the ceftibuten group and by 93% of subjects in the amoxicillin group. We found no significant differences between the ceftibuten and amoxicillin groups with respect to resolution of middle ear effusion, rate of recurrence or side effects. CONCLUSIONS: Amoxicillin remains the drug of first choice for treatment of otitis media with effusion when treatment is deemed advisable, but ceftibuten may be an alternative drug in selected situations.

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.

Amoxicillin-clavulanate potassium compared with cefaclor for acute otitis media in infants and children.

One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.

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)

Concentration of cefuroxime in serum and middle ear effusion after single dose treatment with cefuroxime axetil.

Antimicrobial agents play an important role in the treatment of patients with acute otitis media and otitis media with effusion (OME). The study was undertaken to determine the concentrations of cefuroxime in the blood and middle ear effusions (MEE) of children between 6 and 12 years of age with acute otitis media and chronic OME after a single oral dose administration of cefuroxime axetil, the ester prodrug of cefuroxime. Cefuroxime axetil (250 mg) was administered 2 to 6 hours before either myringotomy for acute otitis media or myringotomy and tube insertion for chronic OME. Blood samples and middle ear aspirates were obtained from 31 children and the samples were analyzed by high performance liquid chromatography. Cefuroxime was recovered in measurable concentrations in all serum samples and in 15 (79%) of the 19 MEE specimens analyzed. No correlation was seen between cefuroxime MEE concentrations and effusion type, bacteriology or serum concentrations. This study shows that cefuroxime does penetrate into MEE when OME is present and that therapeutic concentrations can be achieved in some patients.