It~temational Journul of Pediatric Otorhinolaryngologq., 24 (19Y2)25-33 CC 1992 Elsevier Science Publishers B.V. All rights reserved 0165.587h/9?/$05.00



007Y I

Medical treatment of chronic suppurative otitis media without cholesteatoma in children a two-year follow-up Albert0 ’ Depurtment


‘, Dan M. Fliss 1 and Ron Dagan

of’Otolupwgolog?i and the Pediatric Infectious Disease L’nit -‘, the Soroka CJm/,ersity Medical C‘etlter and the Faculty of Health Sciences, Ben-Guriotl Unir,er.sity of the Neger’. Beer-She[ ‘I llsrtrell


Key words: Chronic

otitis media;

(Received IO June IYYl) version received I1 Septemher (Accepted I3 September 1991)


(~‘hild; Parenteral




A prospective long-term study was carried out in 4X infants and children with chronic suppurative otitis media without cholesteatoma treated initially with wide spectrum intravenous antibiotics and suction and debridement. Patients were followed for a period of two yearsAl children were cured after completion of therapy. At 3 and 6 months follow-up 75% of the children were still free of discharge and at 12, 18 and 24 months the proportion of dry ears dropped to 71%, 66% and 52%, respectively. Eighty percent of all recurrences developed already during the first 6 months of follow-up. Pseudomonas aeruginosa was the most common pathogen isolated, both in the initial and recurrent bouts of the disease. and was commonly associated with other pathogens. Children with early reappearance of ear discharge were less likely to benefit from further antimicrobial or surgical treatment. The recurrence rate was not affected by the antibiotic regimen, age, duration of drainage before treatment or the presence of granulation tissue. No intracranial or intratemporal complications were observed during the follow-up period.

Corrrs~>oncfenc~e to: A. Leiberman, Department P.O. Box 151. Beer-Sheva 84101, Israel.

of Otolaryngology.







Chronic suppurative otitis media without cholesteatoma (CSOMWC) is a chronic inflammatory process of the middle ear and mastoid characterized by a perforated tympanic membrane and purulent discharge [2,17]. This entity is still commonly encountered in infants and children and may often lead to local destructive changes or, less frequently to intratemporal or intracranial complications [2,3,10,11,14,15]. A standardized approach to the management of CSOMWC has not yet been established since many aspects of the disease (i.e. pathogenesis, incidence, natural history, bacteriology) are still controversial [1,4,5,7,13]. Both Kenna and co-workers [8] and our group [6] have assessed the efficacy and safety of wide spectrum parenteral antibiotic in conjunction with daily suction and debridement in the treatment of CSOMWC in children. This long-term prospective follow-up study in a group of infants and children treated initially with parenteral antibiotics was conducted in order to determine the recurrence rate of the disease, to define the bacteriology of recurrent episodes and to investigate the prognostic value of clinical variables.


and methods

The patients derived from children referred routinely to our outpatient otolaryngological clinic. The patients presented in this study are the same group in which evaluation following antibiotic therapy was already reported [6]. Inclusion criteria were: (1) continous otorrhea through a perforated tympanic membrane or a ventilating tube for a minimum of 2 months; (2) males and females 6 months-16 years; (3) failure after completion of at least 10 days of a conventional oral antimicrobial treatment; (4) no topical or systemic antibiotics during the week before enrollment. Exclusion criteria were: (1) acute infection of the external ear canal; (2) the presence of cholesteatoma; (3) evidence of intracranial or intratemporal complications; (4) a history of adverse reactions to beta lactam antibiotics; (5) evidence of an underlying serious condition such as immunodeficiency, cystic fibrosis or malignancy. This study was approved by the Soroka Medical Center Committee on the Use of Human Subjects in Research. Parents were verbally informed and consent to the randomized administration intravenous antibiotics was obtained. All children had daily suction and debridement (SD) during the first week before initiation of medical treatment. All patients were treated with daily SD and mezlocillin, 200 mg/kg given intravenously in three divided doses (maximum of 6.0 gm daily) or with ceftazidime, 150 mg/kg given intravenously in three divided doses (maximum of 3.0 g daily). Both groups received antibiotics until 3 days After cessation of discharge. Otomicroscopic examination was performed; the tympanic membrane and the middle ear status, the size and location of granulation tissue and polyps were

recorded. Purulent discharge was obtained from the middle ear through the tympanic perforation by an Alden-Senturia aspirator. The aspirate was introduced into Amies transport medium without charcoal (Exogen Clydebank Industrial Estate, Scotland). All swabs were immediately sent to the bacteriology laboratory and inoculated onto blood agar (T.S.I. + 5% sheep blood), chocolate agar, MaConkey plate, and brain heart infusion. All plates were placed in a 5% CO1 incubator (37°C). No anaerobic cultures were performed. The isolation and identification of bacteria were done by conventional laboratory techniques. Antibiotic sensitivity test was determined using standard concentration of antimicrobial agents by the disc method. Follow-up visits were scheduled at 3, 10, 21 days and 3, 6, 12, 18 and 24 months after discharge for otomicroscopic evaluation of the tympanic membrane, middle ear status, the presence of discharge and the size and location of granulation tissue. A second course of intravenous antibiotics in conjunction with daily SD was offered in cases of recurrence. In case of failure of the second antibiotic course, tympanomastoid surgery was recommended.

Results The forty-eight patients who completed the acute treatment phase described in the previous report [6] were enrolled in the present study. All children were free of discharge after completion of antibiotic therapy. The mean time required for stopping ear discharge was 11.3 + 5.3 days for those treated with mezlocillin and 12.5 &-5.5 days for those treated with ceftazidime. None of the children included in the present series had midface anomalies, Down’s syndrome or cleft palate. The demographic characteristics of 48 children initially enrolled are shown in Table I. None of the children had had previous otomastoid surgery other than insertion of ventilation tubes in three patients.

Microbiology In all patients bacterial culture was positive. Pseudomonas spp., mainly Pseudomonas aeruginosa were cultured in 100% of the children (Table I). Sensitivity tests performed showed equal susceptibility of the microorganisms to mezlocillin and ceftazidime except for Staphylococcus which was susceptible to ceftazidime but resistant to mezlocillin. Pseudomonas aeruginosa was isolated in all recurrent cases at 6 months (Table II). In five cases it was associated with E. co/i, in three cases with Staphylococcus uureus and in 2 cases with Haemophilus inj7uenzae. During the period of 12 months of follow-up, Pseudomonas was isolated in six cases. In two cases it was associated with E. coli. Haemophilus inj7uenzae and Staphylococcus aureus were isolated in conjunction with Pseudomonas in one case each. In two cases from whom Pseudomonas was eradicated at 12 months,



Clinical and microbiologic characteristics of 48 children with CSOMWC 70



Males/Females Age (months) Range Median Children with ventilation tubes Children with bilateral ear discharge Duration of ear discharge (months) Range Median Children with granulation tissue Children with polyps



11-148 48 3 26

C-1 (-)

Microbiology Pseudomonas spp. Enteric Gram negative bacilli Staphylococcus Haemophylus influenzae

2-123 20 14 6

48 16 12 6

6 54

C-1 29 12

100 33 25 12

Staphylococcus aureus persisted (one case> or reappeared

(one case). Discharge was found in three cases which were ‘dry’ at 6 months. Pseudomonas was isolated in two cases, one associated with E. coli and the other with Haemophilus inj?uenzae. In the third case E. coli was the only isolated pathogen.


First follow-up period (days 3, 10, 21)

At the end of the antimicrobial course, discharge. In six patients spontaneous closure during this period. Chronic discharge recurred days after cessation of intravenous therapy gradually dropped to 85% by the 21st day.

all 48 children were free of ear of the tympanic membrane occurred in 5 (10%) of the children within 7 and the proportion of ‘dry’ ears

Second follow-up period (months 2, 3, 6)

At 2, 3, and 6 months follow-up 75% of the children were still free of discharge. A repeated course of intravenous antibiotics was proposed to the 12 children in whom discharge recurred during the first 6 months. The parents of six children refused such treatment. Two of these children underwent tympanomastoid surgery. The other four were locally treated by their family physician, and did not come for further treatment in the ENT clinic. However, the readiness of the family physician to cooperate enabled us to receive information about their clinical course. Six children in whom discharge recurred received a second course of intravenous



Microbiologic findings in 15 cases with recurrence of ear discharge during the year of follow-up No.

Before initial treatment

During first 6 months

of follow-up Pseudomonas




+ + + + + + + + + + + +




E. coli _

+ nd(*) +



+ +


During the period of 7- 12 months of follow-up

Enterobacter S. epidermidis Enterobacler Proteus mirabilis

E. coli

S. pneumoniae H. influenzae









nd E. colr

+ + + +

_ _ + +

E. coli _

dry +

dry + +

+ +





dry E. c,olr H. rnflucnz*e _

E. coli H. infhenzar E. coli _

+ dry






dry dry

dry dry

dry dry



E. co11 E. coli



H. mfhienzac

E. coli _



f + +

_ _ _





do dry




H. influenzae

nd (*) = No Data,

Staph Others ylocoC~-

lost for follow-up

antibiotics (ceftazidime) until 3 days after cessation of discharge for a mean duration of 10.8 k 2.8 days (range 8-13). Cessation of ear discharge was detected in four of these six children. Tympanomastoid surgery was offered to the remaining two children with, discharge.but the parents refused. Third follow-up period (months 12, 18, 24)

During this period six additional patients were lost to follow-up. Of the 42 children examined, 71% remained free of discharge. At 18 months 66% of the children had no discharge (one more patient was lost to follow up> and two years after the initial antimicrobial intravenous course 52% of the children had dry ears (Fig. 1). The clinical course in 36 children who had ‘dry’ ears at 6 months is shown in Fig. 2. At 12 months 91% of these children were still ‘dry’ while at 18 months and at 24 months the percentage of ‘dry’ ears within this group dropped to 84 and 7S%, respectively. The 2-year follow-up of the 12 children in whom discharge recurred within the first 6 months of follow-up is shown in Fig. 3. Of the four children successfully










Time after systemic antibiotic treatment Fig. 1. Fourty-eight


who were successfully treated for CSOMWC-the during a 24-month follow-up.


of dry ears

with a second intravenous course, two remained dry at 12 months. At 18 months only one child from this group was free of discharge and at 24 months all three children followed-up had a discharge. The parents of six children refused a second antibiotic course at six months. Of the two children who underwent tympanomastoid surgery within this group one had dry ears and the other had chronic suppuration at 12 and at 18 months. At 2 years follow-up both children had active suppuration. At 12 months follow-up all four children who refused a second antibiotic course had otorrhea. At 18 months one child had ‘dry’ ears and at 24 months follow-up three of the children followed-up by their family physician had active suppuration. To determine whether there was any difference in outcome between children who had prolonged discharge period and those who had shorter discharge period before initiation of treatment, we divided the children into three groups: (1) those who had discharge less than 12 months; (2) those who had discharge 12-24 treated

12 Months N = 30 3


suppuratlon 18 Months


N = 29 5129


suppuratlon 5

24 Months 7128

N = 28

Fig. 2. Long-term


suppuratlon follow-up

of 36 children

with ‘dry’ ears at 6 months.

Course of 12 Children in whom Suppuration Recurred Within the First 6 Months


r-i t

12 mos








of 12 children



24 mos

Fig. 3. Course


18 mos

in whom suppuration







the first 6 months.

D =‘dry’


S = suppuration.

months; and (3) those who had discharge > 24 months. No differences were found as for the duration of treatment needed to stop ear discharge (mean time to cure 12.1, 12.2 and 12.2 days, respectively). Similarly, when children were divided to age groups ( < 2 years old, 2-5 years old and > 5 years old) or when divided into those with or without granulation tissue or polyps, no differences in time to cure were observed. Recurrence was observed in the same rate regardless of the duration of discharge prior to treatment, the age or the presence of granulation tissue, but the numbers were too small to perform statistical analysis. The three patients who initially presented with CSOM in the presence of ventilating tubes, were cured without removal of the tubes and remained discharge-free throughout the follow-up period.

Discussion The uncertainty and controversy regarding the treatment of chronic suppurative otitis media without cholesteatoma (CSOMWC) in children stems from the paucity of information documentng the pathogenesis and natural history of the disease, lack of studies with regard to the bacteriology and controlled clinical studies reporting the efficacy of medical or surgical treatment [7,8,10,11,13]. Recently we have reported the first prospective controlled study on the medical treatment of CSOMWC in children [61. A 100% success rate was documented after completion of specific intravenous antibiotic therapy in conjunction with local suction and debridement. Kenna and co-workers [S] reported resolution of otorrhea in 89% of their patients with CSOMWC. However, their study did not exclude children with anatomical defects, immunodeficiency, and the follow-up period was not uniform. The criteria used in order to accurately estimate the outcome of CSOMWC after


successful medical treatment should not only be the eradication of middle ear suppuration, but also the protection against further bouts of middle ear infection and the reduction of long-term complications such as intracranial or intratemporal suppuration. An important finding was that in most cases in whom suppuration recurred, it occurred early during follow-up: 80% of all recurrences occurred during the first 6 months of follow-up. Furthermore, in both children in whom suppuration recurred early and who underwent tympanomastoid surgery otorrhea was stil present at 24 months follow-up. It may be suggested that these children are ‘chronic suppurative otitis media prone’. Further evaluation regarding the etiology and pathogenesis of the disease needs to be accomplished. The role of surgical treatment alone or in combination with antibiotic treatment in improving the outcome could not be evaluated in the present study, since for such an evaluation a randomized prospective study should be designed. Such a study will have to include a large group size to reach statistically significant results and may not be ethical in the presence of relatively high cure rate with antibiotic treatment alone. The isolated microorganisms reported here are in accordance with the pathogens reported by Kenna and co-workers [91. However, the present study shows that Pseudomonas aeruginosu was isolated in the great majority of the recurrent cases at 6 and 12 months follow-up demonstrating the difficulty in its eradication by defence mechanisms or therapy. The presence of granulation tissue in cases with CSOMWC has been suggested as a significant factor in the development of complications [12,16,17]. In the present study, variables such as age, duration of clinical manifestations before initiation of therapy, and the presence of granulation tissue or polyps were not related to the treatment outcome or the recurrence rate of the disease at any follow-up period. Otitis media with and without cholesteatoma may potentially lead to intratemporal and intracranial suppurations [2,41. Furthermore, we were able to document an absence of intratemporal or intracranial complications in all children initially treated with systemic antibiotics. We conclude that children in whom suppuration recurs within the first 6 months after completion of intravenous antibiotic treatment for CSOMWC are less likely to benefit from this therapeutic regimen. Pseudomonas aerugin~~a is the most common pathogen isolated in the recurrent bouts of the disease often in conjunction with other pathogens. The age, duration of drainage and the presence of granulation tissue are of no predictive value in the evaluation of recurrence. We believe that the results of this long term investigation may contribute to better understanding of the management of CSOMWC in children. References 1 Bluestone, surgery,

C.D. and Kenna, M.A., Chronic Pediatr. Ann., 13 (1984) 417-421.







2 Bluestone, C.D. and Klein, J.O., Intracranial complications and sequela of otitis media. In C.D. Bluestone, S.E., Stool and M.D. Scheetz (Eds.), Pediatric Otolaryngology. W.B. Saunders, Philadelphia. 1990, pp. 502-507. 3 Brown, 0.1:. and Meyerhoff, W.L., Complications and sequela of chronic suppurative otitls media: etiology and management. Ann. Otol. Rhinol. Laryngol.. 97 Suppl. 131 (1988) 38-40. 4 Browning. G.G.. The unsafeness of ‘safe’ ears. .I. Laryngol. Otol., 98 (19X4) 23-26. 5 Browning, G.G.. Gatehouse, S. and Calder, T., Medical management of active chronic otitis media: a control study, J. Laryngol. Otol., 102 (1988) 9l-YS. 6 Fliss. D.M., Dagan, R., Houri, Z. and Leiberman, A., Medical management of chronic suppurative otitis media without cholesteatoma in children, J. Pediatr.. I I6 (1990) 991-996. 7 Jahn, A.F.. Abramson. M.. Medical management of chronic otitis media. Otolaryngol. Clin. N. Am.. 17 (1984) 673-677. 8 Kenna, MA.. Bluestone, C.D., Reilly, J.S. and Lusk, R.P., Medical management of chronic suppurativr otitis media without cholesteatoma in children. Laryngoscope. 96 (1986) l46- I5 I. 0 Kenna, M.4. and Bluestone, C.D.. Microbiology of suppurative otitis media in children. Pediatr. Infect. Dis., 5 (I 986) 223-225. IO Kenna, M.A.. Epidemiology and natural history of chronic suppurative otitls media. Ann. Otol. Rhinol. Laryngol., 97 Suppl. 131 (198X) 8. I I Mawson, R.S. and Ludman, H., In Disease of the Ear. A Textbook of Otology. Year Book Medical Publishing Inc., Chicago, 1979, pp. 335-35 I. 12 Meyerhoff. W.L., Kim, C.S. and Paparella, M.M., Pathology of chronic otitis media. Ann. Otol. Rhinol. Laryngol., 87 (1978) 749-760. I3 Nelson, J.D.. Management of chronic suppurative otitis media: a survey of practicing pediatricians. Ann. Otol. Rhinol. Laryngol., 97 Suppl. 131 (1988) 26-2X. 14 Paparella, M.M.. Hiraide, F., Oda, M. et al., Pathology of sensorineural hearing loss in otitis media. Ann. Otol. Rhinol. Laryngol., 81 (1972) 632-647. 15 Proctor, C.A.. Intracranial complications of otic origin, Laryngoscope, 76 (1966) 288-308. 16 Sade. J. and Berco, E., Bone destruction in chronic otitis media. A histopatological study. J. Laryngol. Otol., 88 (1971) 413-422. 17 Senturia, B.H., Bluestone, CD., KLein, J.O. et al.. Definition and classifcation: report of the Ad Hoc Committee on definition and classification of otitis media and otitis media with effusion, Ann. Otol. Rhinol. Laryngol., 89 Suppl. 68 (1980) i-4. 18 Thomsen. J., Jorgensen., M.B., Bretlau, P. et al., Bone resorption in chronic otitis media. A histopathological and ultrastructural study. I. Ossicular necrosis. J. Laryngol. Otol., 8X (lY74) 97%Y81.

Medical treatment of chronic suppurative otitis media without cholesteatoma in children--a two-year follow-up.

A prospective long-term study was carried out in 48 infants and children with chronic suppurative otitis media without cholesteatoma treated initially...
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