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.

Perilymph fistulas in infants and children.

During the years 1975 through 1981 we performed exploratory tympanotomies on 33 infants and children (44 ears) to verify the presumptive diagnosis of perilymph fistula (PLF). A PLF was identified at the round window, oval window, or both in 29 (66%) of the 44 ears explored. After surgery hearing was unchanged in 86%, improved in 5%, and worsened in 9% of the ears in which PLFs had been observed. Complaints of vertigo subsided in all children in whom a PLF was repaired. Preoperative factors determined to be highly suggestive of the presence of a PLF included the following: sudden onset of sensorineural hearing loss (SNHL), congenital deformities of the head, and abnormal findings on tomograms of the temporal bones, especially Mondini-like inner ear dysplasias. Middle ear abnormalities (primarily congenital) were observed in 20 of the 44 ears. Abnormal results of preoperative vestibular function studies, which included a fistula test, and sex were not consistently found to be associated with an observed PLF at tympanotomy.

An animal model of acute otitis media consequent to beta-lactamase-producing nontypable Haemophilus influenzae.

A chinchilla model of acute otitis media with effusion consequent to beta-lactamase-producing nontypable Haemophilus influenzae was developed using the method of direct inoculation of 145 colony-forming units (CFU) or 252 CFU of beta-lactamase-producing nontypable H influenzae into the right superior bullae of 40 chinchillas. The course of the disease was documented longitudinally by otomicroscopy, tympanometry, and periodic culturing of the middle ears. Onset of the disease occurred in 100% of the animals between two and six days postinoculation and resolution was complete in all ears by day 36. Results of rechallenge with the same organism support the combined effect of a local and weaker systemic middle ear protective mechanism rendering resistance to reinfection with a homologous organism in the chinchilla.

Antibiotics and steroids in the treatment of acquired subglottic stenosis. A canine model study.

The efficacy of a combination of systemic antibiotics and a steroid in the prevention of acquired subglottic stenosis (ASGS) was evaluated employing a previously developed canine animal model. Thirty-five healthy, postweanling mongrel puppies aged 5 weeks were each intubated for 14 days with an uncuffed polyvinyl endotracheal tube. Twenty puppies received intramuscular dexamethasone (1 mg) daily, and procaine penicillin (100,000 IU) and dihydrostreptomycin (0.125 g) in two divided doses on the day of intubation and each day thereafter until the completion of the study. The remaining 15 puppies served as a control group and received no medical therapy. Animals from both groups were killed at 5, 7, 12, 15, 20, 30, and 56 days following intubation. Comparative examinations of the laryngotracheal complexes of treated and control dogs showed that there was no significant difference between the two groups in the ultimate degree of ASGS attained, as determined by intraluminal cross-sectional area analysis, or in the extent of the lesion as documented by gross and microscopic histology. This investigation showed that the specific systemic combination of two antibiotics and a steroid used in the study was not efficacious in the prevention of ASGS in a canine animal model; for this reason we question the benefit of analogous medical regimens employed to prevent ASGS in infants and children who require long-term endotracheal intubation.

Longitudinal study of the efficacy of ampicillin in the treatment of pneumococcal otitis media in a chinchilla animal model.

A chinchilla animal model was used to determine the effects of early antibiotic treatment with ampicillin or the local and systemic protective mechanisms during pneumococcal acute otitis media with effusion (AOME). The right bullae of 74 chinchillas were inoculated with 170 colony-forming units (CFU) of Streptococcus pneumoniae type 7F, and animals were randomly assigned to 1 of 2 groups: early (24 hours postinoculation) and late (12 days postinoculation) initiation of ampicillin treatment. During the first challenge, 52 chinchillas died within a 1-month period, apparently from suppurative complications of AOME. Following the resolution of AOME in their right ears, all surviving animals were challenged for the second time by bilateral bullar inoculations using 130 CFU of the same organism. All 10 animals in the early ampicillin treatment group developed severe bilateral AOME, whereas only 3 of the 12 animals in the late ampicillin treatment group developed a recurrence of AOME in the right ear. Significantly, 8 of the 12 animals in this group developed severe left AOME. These findings suggest the presence of a local middle ear defense system and support the results of previous similar studies in which S pneumoniae types 3 and 6A were used. The results of the present study also suggest that in the chinchilla the early administration of a systemic antibiotic (ampicillin) interferes with this defense mechanism.

Craniofacial resection for ethmoid carcinoma in children.

The combined craniofacial resection is a well-established method of managing invasive primary malignant nasoethmoidal disease in adults, and serves as an excellent surgical technique for the en bloc eradication of these lesions [6]. The nasoethmoid region is a relatively uncommon site for the development of primary carcinoma. Less than 3% of cancers involving the adult upper aerodigestive system arise in this area [11,13]. Because similar lesions occur in the pediatric population even less frequently, there has been little opportunity to gain the knowledge necessary to develop a standardized treatment of this disease in children. We report the use of a combined therapeutic regimen consisting of cobalt-60 radiotherapy, surgery and chemotherapy, to manage a primary malignant undifferentiated carcinoma of the ethmoid complex in an adolescent. Since the initiation of treatment at the Cincinnati Children's Hospital, the child has remained free of tumor for 24 months. The techniques of craniofacial resection for the removal of certain tumors in the nasoethmoid complex of adults may be easily adapted for use in the pediatric population, and should be included in the surgical armamentarium of the otolaryngologist providing this type of health care for children.

Endolaryngeal neurofibromas.

A neurofibroma in the larynx is quite unusual and is more likely to appear as a solitary, isolated lesion rather than a concomitant finding in von Recklinghausen's disease. A case is presented of a patient with residual endolaryngeal neurofibroma despite eight attempts at removal. The importance of complete extirpation during the initial operative procedure using frozen sections to guarantee clear surgical margins is advocated.

Acquired subglottic stenosis following prolonged endotracheal intubation. A canine model.

We developed a canine animal model of subglottic stenosis following prolonged intubation with modified non-cuffed endotracheal tubes. None of the puppies intubated for seven days had an irreversible stenosing subglottic lesion, whereas all animals intubated for 14 days or more had at least a 40% to 50% reduction of the subglottic lumen secondary to maturing fibrotic stenosis. The model described is more congruent with the known and suspected pathogenesis in those infants and children who require prolonged endotracheal intubation and subsequently acquire subglottic stenosis, and can be used in evaluating the efficacy of medical therapy or surgical therapy, or both, in the prevention or management of this disease.

Treatment of ampicillin-resistant acute otitis media in the chinchilla.

The efficacy of sulbactam sodium (CP45,899-2) was investigated using the chinchilla animal model of acute otitis media with effusion (AOME). Both ears of 78 chinchillas were inoculated with beta-lactamase-producing nontypable Hemophilus influenzae. Half of the animals were treated with ampicillin sodium alone (group A) and the remaining animals received ampicillin plus sulbactam (group B). On day 14, all of the ears in group B were culture-negative whereas H influenzae was recoverable in over 70% of the effusions in group A. Similarly, the course of middle ear effusion was significantly abbreviated in group B during the two-week study period. These findings suggest that sulbactam in combination with ampicillin is effective in treating AOME secondary to infection with beta-lactamase-producing nontypable H influenzae in the chinchilla animal model.