Efficacy of a stepwise protocol that includes intravenous antibiotic therapy for the management of chronic sinusitis in children and adolescents.

BACKGROUND: Recent concern regarding interference with facial skeletal growth and the risk of complications after endoscopic sinus surgery (ESS) has led to interest in exploring other treatment options for the management of chronic sinusitis in children. OBJECTIVE: To present the use of a stepwise protocol that includes intravenous (IV) antibiotic therapy as a therapeutic alternative to pediatric ESS. DESIGN: Retrospective analysis of pediatric patients with chronic sinusitis treated from January 1, 1993, to July 1, 1998, with a stepwise protocol that includes the use of IV antibiotics. SETTING: Academic tertiary care children's hospital. PATIENTS: Seventy patients, aged 10 months to 15 years, with the diagnosis of chronic sinusitis as defined by symptomatic disease for at least 12 weeks. All patients had persistent symptoms and radiographic evidence of sinus disease by computed tomographic scan after a minimum 3- to 4-week course of oral antibiotics. INTERVENTIONS: Patients were treated with maxillary sinus aspiration and irrigation with selective adenoidectomy, followed by a 1- to 4-week course of a culture-directed IV antibiotic. Most patients also underwent placement of a long-arm IV catheter. OUTCOME MEASURES: Medical charts were reviewed for clinical response to IV antibiotics, complications from IV antibiotic therapy, need for ESS, and recurrent episodes of sinusitis. RESULTS: Of the 70 patients studied, 62 (89%) had complete resolution of symptoms following IV therapy with selective adenoidectomy. Eight patients (11%) failed IV therapy and required ESS. Thirty-seven patients (53%) underwent concurrent adenoidectomy. Patients treated with concurrent adenoidectomy had equivocal response rates compared with patients treated with IV antibiotic therapy alone. Follow-up data were available for 52 patients (range, 6-62 months; mean, 25 months). All recurrent episodes resolved with oral antibiotic therapy. Complications from IV therapy included superficial thrombophlebitis in 6 patients (9%) and dislodgement of a catheter guidewire during placement in 1 patient (1%), requiring venotomy. Antibiotic-related complications also occurred in 3 patients (4%) and included serum sickness, pseudomembranous colitis, and drug fevers. CONCLUSION: A stepwise protocol that includes IV antibiotic therapy is a safe and efficacious mode of therapy for the management of chronic sinusitis in children and adolescents and may be a reasonable alternative to pediatric ESS.

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.

Antibiotic theory in otitis media.

Otitis media is currently the most common diagnosis made by clinicians, which has a major impact on managed care. The emergence of resistant bacterial pathogens has caused controversy over the use of antibiotics when acute otitis media (AOM) is diagnosed. All infants with AOM and all older children with severe AOM should be treated with antibiotics, despite concerns about rising rates of resistant bacterial pathogens. Some older children with nonsevere AOM may be candidates for initial observation, although this is not confirmed by clinical trials. Antimicrobial agents are not required for otitis media with effusion of recent onset but may be considered if this effusion becomes chronic; in these cases, tympanostomy tube placement may be indicated. Antimicrobial prophylaxis for prevention of recurrent AOM should be reserved for selected patients because of the possible emergence of resistant organisms. Tympanostomy tube placement is a more reasonable option today.

The Becker technique for otoplasty: modified and revisited with long-term outcomes.

OBJECTIVES: To demonstrate a modification of the Becker technique for otoplasty and to evaluate the long-term results. STUDY DESIGN: Case series with follow-up survey assessment. METHODS: A sample of 16 patients treated by a single surgeon at an academic pediatric referral center who met the inclusion criteria was reviewed for surgical results and patient/parental satisfaction. RESULTS: A total of 30 ears underwent repair. Patients ranged from 4 to 17 years (mean age, 8.2 y) with an average follow-up of 4.6 years. One patient had an immediate postoperative hematoma from blunt trauma that was treated with good long-term results. No cases required revision surgery. Preservation of the antihelix with good to excellent ear symmetry was obtained in all patients at follow-up. All patients were happy or very happy with the surgical procedure. All patients had at least five of the six criteria for surgical success as defined by the survey. CONCLUSIONS: This modification of the Becker technique of otoplasty is efficacious for correction of protruding ears with excellent long-term results.

The heritability of otitis media: a twin and triplet study.

CONTEXT: Anatomical, physiological, and epidemiological data indicate that there may be a significant genetic component to prolonged time with and recurrent episodes of otitis media in children. OBJECTIVE: To determine the genetic component of time with and episodes of middle ear effusion and acute otitis media (AOM) during the first 2 years of life. DESIGN: Prospective twin and triplet cohort study with enrollment from 1982 through 1995. SETTING: Otitis Media Research Center in the ear, nose, and throat clinic of Children's Hospital of Pittsburgh, Pittsburgh, Pa. PATIENTS: A total of 168 healthy same-sex twin and 7 triplet sets were recruited within the first 2 months of life; zygosity results were available for 140 sets; 138 (99%) of these were followed up for 1 year and 126 (90%) for 2 years. MAIN OUTCOME MEASURES: Proportion of time with middle ear effusion, episodes of middle ear effusion, and episodes of AOM by zygosity status. RESULTS: At the 2-year end point, the estimate of heritability of time with middle ear effusion was 0.73 (P<.001). The estimates of discordance for 3 or more episodes of middle ear effusion were 0.04 for monozygotic twins and 0.37 for dizygotic twins (P = .01). The estimate of discordance of an episode of AOM in monozygotic twins was 0.04 compared with 0.49 in dizygotic twins (P = .005). CONCLUSIONS: Our study suggests there is a strong genetic component to the amount of time with middle ear effusion and episodes of middle ear effusion and AOM in children.

Management of rhinosinusitis in children.

The authors provide definitions for the different forms of pediatric rhinosinusitis, with an enumeration of the main symptoms and signs. They also provide the indications for CT scan examination and microbiological investigations. In addition, they emphasize the importance of concomitant systemic disease, such as allergy and immunological disorders. The adequate medical management, which is mandatory before any surgery, is considered and discussed, and the indications for surgery are provided.

Adenoidectomy and adenotonsillectomy for recurrent acute otitis media: parallel randomized clinical trials in children not previously treated with tympanostomy tubes.

CONTEXT: Adenoidectomy and adenotonsillectomy are commonly performed in US children to reduce the occurrence of persistent or recurrent otitis media, but evidence supporting the efficacy of the operations is limited. OBJECTIVES: To test the efficacy of adenoidectomy and adenotonsillectomy in children with persistent or recurrent otitis media who had not previously undergone tube placement and to compare the relative efficacy of adenoidectomy alone vs adenotonsillectomy in such children. DESIGN: Two parallel randomized clinical trials. SETTING AND PARTICIPANTS: A total of 461 children aged 3 to 15 years were enrolled at Children's Hospital of Pittsburgh, Pa, between April 1980 and April 1994. Four hundred ten children were observed for up to 3 years. INTERVENTIONS: Children without recurrent throat infection or tonsillar hypertrophy (304 enrolled; 266 followed up) were randomized to either an adenoidectomy, adenotonsillectomy, or control group; children who had such conditions (157 enrolled; 144 followed up) were randomized to an adenotonsillectomy or control group. MAIN OUTCOME MEASURES: Occurrence rate of episodes of acute otitis media by treatment group and estimated proportion of time with otitis media. RESULTS: In both trials, most subjects were eligible because of recurrent acute otitis media, with or without persistent otitis media with effusion. A total of 47 children assigned to surgical treatment groups had no surgery. The efficacy of surgery in both trials was modest and limited mainly to the first follow-up year. The largest differences in that year were found in the 3-way trial between the adenotonsillectomy group and the control group: mean annual rate of episodes of acute otitis media, 1.4 vs 2.1 (P<.001); and mean estimated percentage of time with otitis media, 18.6% vs 29.9% (difference, 11.3%; 95% confidence interval, 4.4%-18.2%; P=.002). Perioperative and postoperative complications or other adverse events occurred not infrequently, especially among subjects undergoing adenotonsillectomy (14.6%). CONCLUSIONS: Our study showed limited and short-term efficacy of both adenoidectomy and adenotonsillectomy; given the risks, morbidity, and costs of these procedures, these data suggest that neither operation should ordinarily be considered as a first surgical intervention in children whose only indication is recurrent acute otitis media.

Effects of nasal obstruction on Eustachian tube function and middle ear pressure.

To evaluate the relationship between nasal obstruction and otitis media, 10 ferrets were studied before and after either unilateral (E = 5) or bilateral (n = 5) nasal obstruction. Observations included otomicroscopic assessments of middle ear status, tympanometric recordings of middle ear pressure and forced-response, inflation-deflation and continuous monitoring tests of Eustachian tube function. During the 6 8 week post-obstruction follow-up period no animal developed evidence of otitis media. Abnormal positive middle ear pressures lasting for the period of follow-up occurred only in the animals with bilateral nasal obstruction. Eustachian tube function test results showed these pressures to be generated during swallowing. No changes in the passive function of the tube were documented in either group, but changes in active function consistent with alterations in the pressure gradient between the middle ear and the nasopharynx were observed in both groups.

Alternative to endoscopic sinus surgery in the management of pediatric chronic rhinosinusitis refractory to oral antimicrobial therapy.

We determined the safety, feasibility, and efficacy of a treatment regimen consisting of maxillary sinus aspiration and irrigation with or without adenoidectomy, followed by culture-directed intravenous antibiotics and oral prophylaxis, for children with chronic rhinosinusitis refractory to oral antimicrobial therapy. Twenty-seven children (age 1-12 years, mean 6.7 years) with symptomatic (mean duration 16 months) and computed tomography-proven sinus disease, which persisted despite at least 1 month of oral antibiotics, were treated. Twenty-four patients (89%) had complete resolution of their presenting symptoms after intravenous therapy; in 3 (11%), intravenous therapy failed and endoscopic sinus surgery was required. Follow-up data were available for 26 of the children (96%); 23 of them had initial complete resolution. At last follow-up (mean 282 days, range 26-1095 days), 10 of these 23 patients (44%) remained asymptomatic, and 13 (57%) had had at least one other episode of sinusitis (mean 1.0, range 1-3) treated with oral antibiotics, with resolution. Treatment-related complications included superficial thrombophlebitis (7%), diarrhea (7%), intravenous catheter guide-wire kink requiring venotomy (4%), and serum sickness-like syndrome (4%). These preliminary results suggest that this treatment plan is relatively safe and feasible and that it may be a reasonable alternative to endoscopic sinus surgery in children with chronic rhinosinusitis unresponsive to orally administered antimicrobial 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.

Intratemporal complications of acute otitis media in infants and children.

We reviewed our experience with 100 children admitted to Children's Hospital of Pittsburgh between 1980 and 1995 with an intratemporal complication of acute otitis media. Seventy-two patients were treated for acute mastoiditis. Of these 72 children, 54 (75.0%) were treated conservatively with broad-spectrum intravenous antibiotics and myringotomy. Eighteen (25.0%) required mastoidectomy for treatment of a subperiosteal or Bezold's abscess or cholesteatoma, or because of poor response to conservative therapy. Twenty-two children presented with facial paralysis, complete in 5 (22.7%) and incomplete in 17 (77.3%). Eighteen (81.8%) were treated conservatively, but four required mastoid surgery. Nineteen patients had adequate follow-up; of these, 15 recovered normal facial function but 4 were left with partial paralysis. Three patients presented with serous labyrinthitis and recovered completely with conservative therapy. Of the two patients who presented with suppurative labyrinthitis, one was treated conservatively, but the other required tympanomastoidectomy with cochleotomy; both patients had permanent, profound sensorineural hearing loss in the affected ear. Four patients presented with acute petrositis, and in all four it resolved with mastoidectomy. In the antibiotic era, intratemporal complications of acute otitis media still occur in otherwise healthy children, often after inadequate treatment of acute otitis media.

Treatment of chronic suppurative otitis media with topical ciprofloxacin.

To date, only ofloxacin has been approved by the US Food and Drug Administration for treatment of ears with a nonintact tympanic membrane. The purpose of this study was to determine the safety and efficacy of topical ciprofloxacin hydrochloride in the treatment of experimental chronic suppurative otitis media caused by Pseudomonas aeruginosa infection in cynomolgus monkeys. Forty adult cynomolgus monkeys were divided into 4 equal groups, and their ears were challenged with P aeruginosa, drained for 3 weeks, then treated twice daily for 4 weeks with 1 of 4 randomly assigned agents: 1) ciprofloxacin, 2) saline, 3) Cortisporin, or 4) vehicle. The animals were followed up with auditory brain stem response testing, culture, otoscopy, and histopathology. Both ciprofloxacin and Cortisporin treatment resulted in a significantly more rapid rate of clearance of P aeruginosa as compared to treatment with saline (100% versus 20%). Eradication was not associated with resolution of otorrhea after a 4-week period of treatment. There were no significant changes in auditory brain stem response wave latencies for any of the treatment groups. Histopathologic data revealed that there was no statistically significant difference in the amount of outer hair cell loss for the ciprofloxacin group as compared to the control ear and other treatment groups. We conclude, therefore, that topical ciprofloxacin is not ototoxic and is effective in sterilizing the otorrhea, but does not promote resolution of the drainage, in this animal model.

Epidemiology and pathogenesis of chronic suppurative otitis media: implications for prevention and treatment.

Despite advances in public health and medical care, chronic suppurative otitis media is still prevalent around the world. It is most common in developing countries and in certain high risk populations in developed nations, as well as among children who have tympanostomy tubes inserted. Since this chronic infection is caused by persistent acute otorrhea, which in turn is usually secondary to acute otitis media, prevention should be directed toward prompt and appropriate treatment of the acute middle-ear infection. Repair of chronic perforations should prevent recurrence, since reinfection is due either to reflux of pathogenic organisms from the nasopharynx into the middle ear, or water contamination from the external canal. Information from epidemiological studies, which show that populations can be categorized into highest, high, low and lowest prevalence, can be helpful in setting national priorities for prevention and treatment.