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Efficacy of a Stepwise Protocol That Includes Intravenous Antibiotic Therapy for the Management of Chronic Sinusitis in Children and Adolescents
Debra M. Don, MD;
Robert F. Yellon, MD;
Margaretha L. Casselbrant, MD, PhD;
Charles D. Bluestone, MD
Arch Otolaryngol Head Neck Surg. 2001;127:1093-1098.
ABSTRACT
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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.
INTRODUCTION
OPTIMAL management of chronic sinusitis in the pediatric patient remains
a controversial issue. Recommended therapy for pediatric chronic sinusitis
ranges from functional endoscopic sinus surgery (ESS) to minimal or no intervention.1-4 During
the past decade, ESS has been widely used and advocated as the treatment of
choice for chronic sinusitis refractory to medical management in children.
However, recent concern regarding interference with facial skeletal growth
and the risk of complications after ESS has led to interest in exploring other
treatment options.5-7
The purpose of this study was to expand an initial preliminary report8 on the use of a stepwise protocol that includes intravenous
(IV) antibiotic therapy as an alternative to pediatric ESS.
MATERIALS AND METHODS
The medical records of 70 pediatric patients treated with IV antibiotics
for symptoms of chronic sinusitis between January 1, 1993, and July 1, 1998,
were studied. Each child's medical record was examined for demographic information,
presenting signs and symptoms, atopic history, immune status, past surgical
history, maxillary sinus culture, computed tomographic (CT) scan findings,
complications of IV therapy, need for ESS, and recurrent episodes of sinusitis
following IV therapy. Inclusion criteria included (1) sinonasal symptoms of
at least 12 weeks' duration, (2) failure to respond to a minimum 3- to 4-week
course of a ß-lactamase stable oral antibiotic, and (3) rhinosinusitis
as documented by CT scan after the oral antibiotic course. Computed tomographic
scan findings considered to be consistent with sinusitis included partial
or complete sinus opacification. Patients with cystic fibrosis, craniofacial
anomalies, metabolic disorders, or immunodeficiencies were excluded. Patients
were also excluded if they had a history of sinonasal surgery or significant
anatomic abnormalities on CT scan that would require ESS or septoplasty. All
patients were treated with the following regimen: (1) nasal endoscopy, bilateral
maxillary sinus aspiration and irrigation, and long-arm IV catheter placement
under general anesthesia and (2) culture-directed IV antibiotics for a minimum
of 1 week or until symptoms resolved. Concurrent adenoidectomy was performed
at the discretion of the surgeon. Decisions were based on the finding of adenoid
hypertrophy on intraoperative examination or preoperative CT scan.
Intraoperative maxillary sinus cultures were obtained through the following
techniques: (1) cottonoid pledgets impregnated with povidone-iodine and oxymetazoline
hydrochloride were placed in the nasal cavity for 5 to 10 minutes, (2) maxillary
sinuses were entered via inferior meati punctures using a sterile 18-gauge
spinal needle or trocar, and (3) sinus contents were aspirated and sent for
aerobic and anaerobic culture and susceptibility studies. When no material
was aspirated, irrigation with 10 mL of isotonic sodium chloride was subsequently
performed. Following irrigation, the sinus contents were reaspirated and sent
for microbiologic examination.
Postoperatively, IV antibiotics were administered empirically. An initial
test dose of the IV antibiotic was given postoperatively in the hospital.
Thereafter, patients received the antibiotic on an outpatient basis and had
home nursing for assistance with their care. Follow-up visits were scheduled
as needed during the IV antibiotic regimen and thereafter. Based on culture
and susceptibility studies, the antibiotic agents were altered accordingly.
Assessment of the presence or absence of sinonasal symptoms and an estimate
of overall improvement and long-term symptom control were made at each follow-up
visit. After discontinuation of the IV antibiotic, some patients were immediately
prescribed a prophylactic oral antibiotic for varying durations at the discretion
of their otolaryngologist.
RESULTS
Of the 70 patients studied, 47 were boys and 23 were girls. Patient
age at clinical presentation ranged from 10 months to 15 years, with a mean
and median age of 6.4 and 6.0 years, respectively, and an SD of 3.7 years.
The most frequently reported presenting symptoms were nasal congestion, rhinorrhea,
and cough (Table 1). The mean
duration of these symptoms was 6.5 months (range, 3-120 months). The mean
duration of preoperative oral antibiotic use was 4 weeks (range, 3-12 weeks).
Before referral, many patients were treated with multiple antibiotic trials,
with a mean of 4 courses (range, 1-10 courses).
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Table 1. Presenting Symptoms in 70 Patients Treated With Intravenous
Antibiotic Therapy for Chronic Sinusitis
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Factors associated with chronic sinusitis were analyzed in each patient
(Table 2). The most common coexisting
conditions were a family history of atopy and personal history of otitis media,
asthma, and tonsillitis. Environmental risk factors, such as passive smoke
exposure and day care, occurred in some patients. Allergy testing was performed
in 55 patients (79%), with 28 (51%) having a positive reaction to allergens.
Immunologic testing was performed in 32 patients (46%), and none were identified
as having immunodeficiencies.
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Table 2. Coexisting Conditions and Environment Risk Factors in 70 Patients
Treated With Intravenous Antibiotic Therapy for Chronic Sinusitis
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Preoperative CT scans demonstrated varying degrees of maxillary and
ethmoid sinus mucosal thickening in most patients (Table 3). Frontal and sphenoid sinus involvement was present in
fewer patients. The most prevalent presenting physical findings were edematous
nasal mucosa (94%) and purulent exudate within the nasal cavity (80%). Thirty-two
patients (46%) had undergone prior otolaryngologic procedures. Previous ventilation
tube insertion had been performed in 22 patients (31%), adenoidectomy in 24
patients (34%), and tonsillectomy in 6 patients (9%). Preoperatively, 30 patients
(43%) had been treated with topical nasal steroids, while 14 (20%) had been
administered systemic antihistamines.
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Table 3. Preoperative CT Scan Findings in 70 Patients Treated With
Intravenous Antibiotic Therapy for Chronic Sinusitis
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Thirty-seven patients (53%) underwent concurrent adenoidectomy, with
8 being revision procedures. Eighteen patients (26%) had other otolaryngologic
surgeries performed simultaneously. These included direct laryngoscopy and
bronchoscopy in 6 patients (9%), tonsillectomy in 4 (6%), and ventilation
tube insertion in 10 (14%). Intraoperatively, the maxillary sinuses were entered
without difficulty in all patients. Purulent material was obtained in only
23 (18%) of 129 maxillary sinus aspirates. The remaining 106 maxillary sinuses
(82%) had either bloody or clear aspirates following irrigation. Five patients
(7%) had unilateral maxillary sinus aspirations, while 3 (4%) did not undergo
aspiration. From the latter group, 2 patients (3%) underwent adenoidectomy
and IV catheter placement, and 1 patient (1%) had long-arm IV catheter placement
alone.
Postoperatively, the mean duration of IV antibiotic therapy was 17 days
(range, 7-42 days). Cefuroxime sodium was the most common antibiotic, administered
to 30 (43%) patients. Ampicillin sodium with sulbactam sodium was used in
22 patients (31%), ticarcillin cresyl sodium with clavulanate potassium in
15 patients (21%), ceftriaxone sodium in 2 patients (3%), and vancomycin hydrochloride
in 1 patient (1%) were also used. Changes in empiric antibiotic choices were
made in 4 patients because of antibiotic resistance found on susceptibility
studies. Three patients had penicillin-resistant Streptococcus
pneumoniae isolated, while 1 patient had a multidrug-resistant Staphylococcus aureus cultured, which required vancomycin
for resolution. In 3 other patients, antibiotic changes were made because
of allergic reactions. Forty-seven patients (67%) were also administered oral
antibiotic prophylaxis following completion of their IV therapy. Various oral
antibiotics were prescribed, including amoxicillin, amoxicillin with clavulanate,
cefprozil, cefuroxime, azithromycin, cefpodoxime proxetil, and a combination
of trimethoprim and sulfamethoxazole. Amoxicillin-clavulanate was the most
common antibiotic administered and was used in 18 patients (38%). Maintenance
doses of the oral antibiotics were taken prophylactically by patients for
a mean of 8 weeks (range, 4-16 weeks). Following the completion of the treatment
protocol, 12 (17%) and 7 (10%) patients were also maintained on intranasal
steroids and systemic antihistamines, respectively. Systemic steroids were
not administered to any of the patients.
Fifty-one (73%) of 70 patients and 76 (59%) of 129 aspirates were culture
positive for at least 1 organism (Table
4). Thirty patients (43%) had multiple organisms cultured, and 21
patients (30%) had the same organism cultured bilaterally. The organism most
frequently isolated was Haemophilus influenzae, which
was found in 32 (42%) of the aspirates. Other commonly identified bacteria
were  -hemolytic streptococci, Moraxella catarrhalis, S pneumoniae, and coagulase-negative staphylococci.
Thirty-four (24%) of 142 organisms were found to have penicillin resistance
after susceptibility testing. Anaerobic bacteria were identified in 13 aspirates
(17%).
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Table 4. Microbial Pathogenic Findings of 76 Maxillary Sinus Aspirates
From 51 Children With Chronic Sinusitis*
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Ten patients (14%) developed complications. Catheter-related thrombophlebitis
occurred in 6 patients (9%) and was successfully treated in all cases with
catheter removal and local wound care. In 1 patient (1%), a guidewire became
lodged during catheter insertion, requiring venotomy for removal. Three patients
developed antibiotic-related complications, including drug fevers (1%), serum
sickness (1%), and pseudomembranous colitis (1%). These complications resolved
with discontinuation of the antibiotics and appropriate medical therapy.
Initial clinical improvement following IV therapy was achieved in 62
patients (89%). Eight patients (11%) had no response to IV therapy and required
ESS. Of those patients with initial clinical improvement following IV antibiotic
therapy, long-term follow-up (defined as >6 months from IV therapy) information
was available on 52 (74%). The mean follow-up in this group of patients was
25 months (range, 6-62 months). Of these 52 patients, 46 (88%) were considered
to be clinically improved by their parents at their last visit. Although 6
patients (12%) were not regarded by their parents to have maintained their
initial clinical improvement, they did not undergo ESS. Twelve (23%) of the
52 patients had no further episodes of sinusitis following IV therapy. Forty
patients (77%) with long-term follow-up had recurrent episodes of acute sinusitis,
all of whom had complete resolution with oral antibiotic therapy (Table 5). Initial and long-term clinical
response rates were not significantly different in patients treated with concurrent
adenoidectomy (primary and revision), compared with those of patients who
did not have concomitant adenoidectomy and were treated only with IV antibiotic
therapy (Table 6 and Table 7). Patients who failed to achieve
a long-term clinical cure with the stepwise protocol had a mean age of 8.0
years and a mean duration of symptoms of 23.5 months. Patients who responded
to treatment and maintained clinical improvement had a mean age of 6.1 years
and a mean duration of symptoms of 16.5 months.
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Table 5. Duration of Long-term Follow-up and Number of Recurrent Episodes
of Sinusitis in 52 Children Treated With Intravenous Antibiotic Therapy
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Table 6. Initial Clinical Response Rates in 70 Children Treated With
Intravenous Antibiotic Therapy With Selective Adenoidectomy for Chronic Sinusitis*
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Table 7. Long-term Clinical Response Rates in 52 Patients Treated With
Intravenous Antibiotic Therapy With Selective Adenoidectomy for Chronic Sinusitis*
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Long-term follow-up (mean, 23.4 months) was available for 7 patients
(88%) who underwent ESS. Of these patients, 3 (43%) responded after surgery
and were considered by their parents to have had continued clinical improvement
at their last visit. During follow-up, these 3 patients also had recurrent
episodes of acute sinusitis, which resolved after treatment with oral antibiotic
therapy. The remaining 4 patients failed to demonstrate any clinical improvement
after ESS and continued to experience chronic sinonasal symptoms.
COMMENT
Pediatric chronic sinusitis is a complex disease whose natural history
and pathogenesis are poorly understood. Primarily because of its multifactorial
etiology, management of chronic sinusitis in children is complicated, and
there is uncertainty about the best method of treatment. Most otolaryngologists
who treat pediatric chronic sinusitis agree that a prolonged course of a broad-spectrum, ß-lactamase
stable oral antibiotic is the cornerstone of medical therapy. Additional measures,
such as topical and systemic steroid therapy, systemic antihistamine and decongestant
use, nasal irrigations, and immunotherapy, may also be beneficial. After optimal
medical therapy, the disease can often be recalcitrant and, as a consequence,
surgical intervention may be considered.
Several surgical options are available for the treatment of chronic
sinusitis in children. Endoscopic sinus surgery has been most widely used
for the treatment of refractory sinusitis in children. The reported success
rates for pediatric ESS range from 80% to 93%.1-2
Despite its apparent benefits, pediatric ESS carries serious risks and, because
of the smaller anatomy, requires greater technical skill and more meticulous
surgery than in adults. In addition, interference with sinus development and
midfacial growth after ESS has been well documented in animal studies and
in anecdotal clinical reports.5-7
Because of these recent concerns, an increasing number of clinicians stress
the medical nature of pediatric chronic sinusitis and urge conservative use
of ESS.3-4
As an alternative to ESS, we advocate a stepwise protocol for the treatment
of pediatric chronic sinusitis (Figure 1).
In our patient population, patients referred with chronic sinusitis (defined
as >3 months' duration) are initially treated with at least a 3- to 4-week
course of a ß-lactamase stable oral antibiotic. Concurrently, most patients
also undergo an allergy and immunology evaluation. If a child's workup is
noncontributory and medical therapy, including allergy management, is not
effective, a CT scan of the paranasal sinuses is performed. This imaging study
allows us to determine the presence or absence of sinus disease and to assess
adenoid size. The CT scan also permits an identification of any significant
anatomic abnormalities that would be more amenable to ESS. Based on these
findings, IV antibiotic therapy with selective adenoidectomy is offered to
appropriate patients as an alternative to ESS. In the event that patients
fail to respond to the IV antibiotics, they subsequently undergo ESS.
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Stepwise treatment protocol for 70 children and adolescents with
refractory chronic sinusitis.
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Our results suggest that this stepwise protocol that includes the use
of IV antibiotic therapy is a reasonable therapeutic option for patients with
refractory chronic sinusitis. Patients treated with IV antibiotics have clinical
response rates similar to those undergoing ESS. Of the 70 patients treated,
62 (89%) had complete resolution of symptoms following IV therapy. In addition,
the IV antibiotic therapy demonstrated minimal complications and was well
tolerated by most patients. Many families also reported that care of the catheter
and administration of the IV antibiotic were easily learned and feasible tasks.
This report differs from a previous series8
in that a larger number of patients were studied for longer periods. Patients
demonstrated equivalent initial clinical response rates (89%) in both studies.
In regards to their long-term outcomes, 45 patients (87%) in the present study
continued to maintain clinical improvement, despite occasional episodes of
acute sinusitis. All of the recurrent sinus infections in these patients resolved
with oral antibiotic therapy.
An analysis of the patients who did not experience or maintain initial
clinical improvement following IV antibiotic therapy revealed certain prognostic
factors. The patients who did not achieve long-term clinical cure were older
than those who responded to treatment. Similarly, patients who failed to sustain
clinical improvement had a longer duration of preoperative symptoms than responders,
suggesting that chronicity of disease may also be a predictive factor. The
patients who subsequently underwent ESS after a failure to respond to the
stepwise protocol did not experience superior resolution of symptoms. In fact,
only 3 (43%) of 7 patients after ESS were judged by their parents to have
had long-term clinical improvement, which suggests that these patients had
more significant manifestations of disease. Other data examined in patients
who did not respond to the stepwise protocol included isolation of antibiotic-resistant
bacteria, history of atopy or asthma, use of prophylactic antibiotic, topical
nasal steroid or antihistamine therapy, and presence of environmental factors,
such as passive smoke exposure or day care. A thorough analysis of these factors
failed to reveal other conditions that could predict a response to treatment.
In this retrospective study, patients were not stratified by severity of sinonasal
symptoms or CT scan findings. Such stratification may be beneficial for future
prospective studies to assist with identifying those children and adolescents
who would be most likely to respond to the stepwise protocol. Ideally, this
would require the use of a CT staging system and a patient-based symptom instrument.
The efficacy of adenoidectomy is widely debated, but preliminary studies9-11 suggest a positive
effect on pediatric sinusitis. It is thought that adenoidectomy improves sinonasal
symptoms by eliminating nasal airway obstruction and stasis of secretions.
Removing the adenoid pad as a potential nidus for bacterial colonization is
also considered important for improving sinus disease. In this study, the
effect of adenoidectomy remains uncertain, because all patients were concomitantly
treated with IV antibiotics. An interesting point, nonetheless, is that IV
antibiotics appear to play an independent role from adenoidectomy in affecting
the sinuses, because patients treated with only IV antibiotic therapy had
clinical response rates similar to those of patients who underwent concurrent
adenoidectomy. This is more apparent when one considers that more than half
of the patients treated with only IV antibiotic therapy had previous adenoidectomy
performed and presumably had no adenoid tissue in the nasopharynx. Some authors12-13 have also reported improvement in
sinus disease after maxillary sinus lavage. Because this procedure addresses
only the maxillary sinus, other authors14-16
are not convinced that it can produce a long-lasting benefit in children.
Therefore, although it is possible that maxillary sinus lavage contributed
to the initial clinical improvement seen in our patients, it is questionable
whether this intervention had an effect on our patients' long-term clinical
outcome.
There is limited information regarding the microbial pathogenesis of
chronic sinusitis in children. Moreover, the data are complicated in many
studies17-20
by the use of various definitions of chronic sinusitis, concurrent antibiotic
administration, and lack of aseptic culture technique. Because of these issues,
the etiologic role of bacterial agents in chronic sinusitis has been viewed
with skepticism by some authors.17, 21-22
They believe that microorganisms play a minor part in the pathogenesis of
chronic sinusitis and emphasize possible structural damage of the sinus mucosa
with loss of its normal state. In the present study, 51 (73%) patients had
microorganisms present in their maxillary sinuses. Because only 34 (24%) of
the organisms demonstrated drug resistance, these results represent for the
most part susceptible bacteria that are persistent after a prolonged course
of a ß-lactamase stable oral antibiotic. These microbial pathogenic data
are similar to what have been reported in other studies19-20
and indicate that bacterial infection may be an important factor in chronic
sinusitis. Sinonasal symptoms improved in most patients following IV antibiotic
therapy, which further supports a bacteriologic cause and suggests that poor
sinus penetration of the oral agent may have led to initial failures.
We also propose that IV antibiotics may be efficacious in the treatment
of chronic sinusitis by interrupting an infectious and inflammatory process
localized within the sinus mucosa and underlying bone. Recent evidence suggests
that active inflammation in the ethmoid bone may be a significant factor in
the persistence of overlying mucosal disease.23
It is therefore conceivable that prolonged IV antibiotic therapy, with increased
blood concentrations, more effectively penetrates bone and alleviates this
condition. The concept of a chronic "osteitis" and the efficacy of IV antibiotics
for this type of disease process have been previously addressed and demonstrated
in patients with chronic suppurative otitis media.24
Further studies are required to definitively establish a causal relationship
in patients with chronic sinusitis.
Although the results of the present study are encouraging, a retrospective
study design has inherent limitations, with possible bias. Because a comparison
with children and adolescents who did not receive treatment was not performed,
it is difficult to distinguish whether the natural course of the disease may
have affected clinical outcomes. The use of multiple interventions (sinus
irrigations, adenoidectomy, and IV antibiotics) also makes it difficult to
separate their individual effects. Despite these deficiencies, this study
suggests that a stepwise protocol that includes the use of IV antibiotic therapy
is a safe and effective alternative to ESS for children and adolescents with
chronic sinusitis.
AUTHOR INFORMATION
Accepted for publication May 16, 2001.
Presented in part at the American Society of Pediatric Otolaryngology
meeting, Palm Springs, Calif, April 29, 1999.
Corresponding author and reprints: Charles D. Bluestone, MD, Department
of Pediatric Otolaryngology, Children's Hospital of Pittsburgh, University
of Pittsburgh School of Medicine, 3705 Fifth Ave, Pittsburgh, PA 15213.
From the Department of Pediatric Otolaryngology, Children's Hospital
of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pa.
Dr Don is now with the Division of Otolaryngology, Children's Hospital of
Los Angeles, Los Angeles, Calif.
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