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Complications of tympanostomy tubes in an inner city clinic population
International Journal of Pediatric Otorhinolaryngology
ELSEVIER
Complications
14 (199h) x7-99
of tympanostomy tubes in an inner city clinic population
Nira A. Goldstein’,
J. Thomas Roland Jr.*2, Nancy Sculerati
Drpurtnwnt of‘ Otolaryngology, New York Uniwrsity School qf Medicine. 550 First Armur. Nm York, NY 10016. USA Received 13 March 1995; revision received 30 June 1995: accepted 6 July 1995
Abstract While both prophylactic antibiotics and tympanostomy tube insertion have a role in the treatment of recurrent acute otitis media (AOM) and otitis media with effusion (OME) in children previous work has shown that patients in our urban clinic are not compliant with prophylactic antibiotics. Concerned about the potential for decreased compliance in a non-compliant population, we performed a retrospective review to assess the incidence of complications from the insertion of tympanostomy tubes in the same pediatric clinic population. A total of 391 tubes were placed in 165 patients. Follow-up ranged from O-49.4 months with a mean of 21.3 months. Three ears (1.14%) had persistent perforations. Tympanosclerosis was found in 30 ears (ll.l’%). No ear showed a chronic retraction or cholesteatoma. Six ears (1.70%) developed postoperative otorrhea. Thirty-five patients had at least one episode of otorrhea outside of the perioperative period, and a total of 60 episodes (19.6% of ears) occurred during the study period. The mean pure tone average prior to tube placement was 25.0 dB, with tubes in place was 2.44 dB and after the last set of tubes had extruded was 6.97 dB. Our study shows that the incidence of complications of tympanostomy tubes was minimal in our inner city clinic population. Keywords: Tympanostomy sis; Otorrhea
tubes; Compliance;
Complications;
Perforation;
Tympanosclero-
* Corresponding author. ’ Kecipient of the 1995 Charles F. Ferguson Award, American Society of Pediatric Otolaryngology. ’ Presented at the 10th annual meeting of the American Society of Pediatric Otolaryngology, Durango, CO, May 1995 0165-5876;96/$09.50 0 1996 Elsevier Science Ireland Ltd. All rights reserved SSDI 0165.5876(95)01259-E
Inc.,
88
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34 (1996) 87-99
1. Introduction The treatment of recurrent acute otitis media (AOM) and otitis media with effusion (OME) in children most often involves either chemoprevention with prophylactic antibiotics or the insertion of tympanostomy tubes. Previous work at our institution showed that at least 53% of families in our urban clinic were non-compliant with prophylactic antibiotic treatment. We advocated that a recommendation for a surgical drainage procedure should therefore be considered for our patient population with problematic otitis media rather than assuming that antibiotic prophylaxis would have the same efficacy as compared to other, more compliant populations [13]. Although the insertion of middle ear ventilation tubes has been shown to have efficacy with a low rate of complications in compliant populations, we were concerned that the actual rate of complications might be higher in our group of patients. A summary of reported incidences of complications of myringotomy tubes is presented in Table 1. No prior study has analyzed complications in an inner city, indigent population. Since compliance with postoperative clinic visits, postoperative water precautions and possible treatment of subsequent otorrhea in this patient population may be poor, tympanostomy tube sequelae may be more severe than in patient populations studied previously. Some study groups have been composed of patients from a private practice [6,12,17,25]. In other studies, patients were recruited to enter a prospective study [l-3,9,1 1,12,23,24,2729,31,34]. Since organized follow-up was arranged for these patients, complication rates may not reflect those in a clinic population. One study analyzed complications in a rural population [16]. Many studies do not discuss the characteristics of the patient population [8,14,19,21,22,26,30,32,33,35].We performed a retrospective review to investigate the incidence of complications in our pediatric urban clinic population. 2. Materials and methods All charts from the Pediatric Otolaryngology Clinic of children who underwent myringotomy with placement of a tympanostomy tube between 21 June 1990 and 13 August 1992 at Bellevue Hospital were retrospectively reviewed. All patients were included in the study. Many of the children had prior sets of myringotomy tubes or additional tubes placed at another institution, but the complications associated with these tubes were not studied. Additional tubes placed between 14 August 1992 and 12 April 1994 in this patient group were included in the analysis. All procedures were performed in the general operating room under general anesthesia, either as an inpatient or on an ambulatory basis depending on whether additional procedures were performed and the medical condition of the patient. Antiseptic preparation of the external auditory canals was not performed. Specific
N.A. Goldstein et ul. ! Int. J. Pediatr. Otorhinolaryngol. Table 1 Literature
review of complications
Author
Tube type
Present Baker [I] Baldwin [2] Balkany [3] Bulkley [6] Debruyne [8] Epstein [9] Gates [l I] Giebink [ 121
Hawthorne [I41 Hilding [16] Hughes [17] Klingensmith
[I91
Luxford
[21]
Mangat [22] Maw [23] Parker [24] Pichichero [25]
Prichard [26] Scott [27] Scott [28] Slack [29] Solomon [30] Tos [31] Tos [32] Von Schoenberg [33] Weigel [34]
Yanagihard
[35]
Armstrong T-tube & grommet Sheehy. Collar button Sheehy Goode T-tube Grommet Donaldson Shepard Donaldson, Robin, Shepard, Reuter Goode T-tube Goode T-tube, Arrow Unknown Paparella I, Pdparella II. Shepard, Armstrong Collar button, Per-Lee, Mesh Goode T-tube Unknown Shepard Armstrong, Collar button, Goode T-tube Goode T-tube Armstrong Armstrong Shepard Shepard, Armstrong Grommet Grommet Goode T-tube Goode T-tube. Armstrong Shepard, Reuter-Bobbin Goode T-tube
of myringotomy Permanent perforation 1.14
((!I)
tubes Cholesteatoma Tympanosclerosis (‘%I) (‘%I)
Chronic retraction
11.1
0
0
0
7.1 -
15.6 1.6 42.1 2.771 1.8
0.83
4.0 32.0
23.6 48.6 40.2 52.3
21.1
.-. 40.0 -
10.3
47.5 0 12
89
34 (1996) 87-99
48.0 59.0 36.0
14.6 0
0
(‘%I)
90
N.A. Goldstein et al. / Int. J. Pediatr. Otorhinolaryngol. 34 (1996) 87-99
Table 1 (continued) Author
Tube type
postop* otorrhea (%)
Episodes otorrhea (%)
Granulation
Present
Armstrong
1.70
19.6
1.96
Baker [l]
T-tube & grommet Sheehy, Collar Button Sheehy Goode T-tube Grommet
o- 19.0
Baldwin [2] Balkany [3] Bulkley [6] Debruyne [S] Epstein [9] Gates [ 111 Giebink [12]
Donaldson Shepard
Donaldson, Bobbin, Shepard, Reuter Hawthorne [14] Goode T-tube Hilding [16] Goode T-tube, Arrow Unknown Hughes [17] Klingensmith Paparella I, Paparella II, 1191 Shepard, Armstrong Collar Button, Luxford [21] Per-Lee, Mesh Mangat [22] Goode T-tube Unknown Maw [23] Parker [24] Pichichero [25]
Prichard [26] Scott [27] Scott [28] Slack [29] Solomon [30] Tos [31] Tos [32]
(%) Hearing loss after tubes extruded 9.84% with PTA** > 20 dB 0% neurosensory loss
6.3-10.0 12.0 -
7.1 10.4
0% neurosensory loss
11.9 3.4 11.0
-
41.0
-
3.8% with sound field >20 dB 0% neurosensory loss
O-31.8
~
19.0
-
21.0
21.0
-
Shepard Armstrong, Collar Button, Goode T-tube Goode T-tube Armstrong Armstrong Shepard
9.3-18.7% 20 dB 8.7 9.8
54.9
-
Shepard, Armstrong Grommet Grommet
Goode T-tube Von Schoenberg [33] Goode T-tube, Wiegel [34] Armstrong, Shepard, Reuter-Bobbin Yanagihara [35] Goode T-tube
with threshold>
Hearing impairment < 0.5 dB in ears with tympanosclerosis -
70.4
-
O-50.0
-
29.0
*Postop, postoperative, **PTA, pure tone average.
12.3
N.A. Goldstein et al. 1 Int. J. Pediatr. Otorhinolaryngol.
34 (1996) 87-99
91
technique of myringotomy varied but usually a radial incision was made in either the anteroinferior or posteroinferior quadrant. A fluoroplastic modified Armstrong bevelled grommet tube was placed in all cases except one in which a Goode T tube was placed. All procedures were performed by residents under attending supervision. Children were routinely given 3 days of topical polymyxin G sulfate-neomycin sulfate hydrocortisone otic suspension postoperatively, but systemic antibiotics were not given unless concomitant tonsillectomy and/or adenoidectomy or cleft palate repair were performed. For each tube placed, data collected included the age of the patient, the indication for the procedure, whether chemoprophylaxis had been attempted and any concomitant procedures such as adenoidectomy, tonsillectomy or cleft palate repair performed. The patient’s subsequent clinic follow-up was also recorded. Ears were examined by residents under the supervision of the senior author, a validated otoscopist. The time until tube extrusion was defined as the time between the insertion date and halfway between the time the tube was seen in the tympanic membrane in clinic and the time it was not seen. The time for the resulting perforations to heal was defined as halfway between the time the tube was last seen in the tympanic membrane in clinic or the time a perforation was first seen and the time an intact tympanic membrane was first seen in clinic. The time until tube extrusion and the time for the resulting perforations to heal were analyzed for the ears of all patients who had sufficient follow-up in clinic such that they were examined until their tubes had extruded. The number of ears which developed permanent perforations, tympanosclerosis, chronic retractions or cholesteatoma were recorded for this patient group. Tympanosclerosis was also seen in several patients who did not follow up in clinic until the tubes had extruded; these ears were also included in the total number of ears with tympanosclerosis. The number of episodes of immediate postoperative (within 2 weeks) otorrhea was recorded from the total number of ears that were examined in the immediate postoperative period. All ears that were examined for at least 7 months postoperatively were included in the analysis of otorrhea outside of the immediate postoperative period and in the analysis of the development of granulation surrounding the tube. The time period of 7 months was chosen arbitrarily. Audiometric data consisting of the pure tone average (PTA) of 500, 1000 and 2000 Hz were recorded for all patients with audiograms prior to tube placement, with tubes in place and after the last tube had extruded. Audiograms consisted of both sound field and play audiometry depending on the age and willingness of the patient. 3. Results During the study period, a total of 391 tubes were placed in 165 patients. Two-hundred-and-nine procedures were performed: 182 bilateral myringotomies with tube placement and 27 unilateral myringotomy with tube placement. The
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34 (1996) 87-99
Table 2 Patient demographics Sex
Age
Race
Male 90 Female 75
Range 9 mo. to 14 years Mean 4.6 years
Caucasian 12 Hispanic 131 Black 12 East Asian 4 East Indian 6
mean number of procedures per patient was 1.27, and the mean number of tubes per patient was 2.37 (range l-6). The demographics of the patient population are presented in Table 2. Many children had additional tubes placed either prior to the study period or at another institution or had additional either concomitant or separate surgical procedures (Table 3). Numerous medical problems were also found in the patient population (Table 4). Prophylaxis for chemoprevention of otitis media was used preoperatively in 73 of the patients. Of the 391 tubes placed 217 were placed for treatment of recurrent AOM (106 bilateral myringotomies and tubes, 5 myringotomies and tubes) and 174 were placed for treatment of OME (76 bilateral myringotomies and tubes, 22 myringotomies and tubes). Patient follow-up in clinic ranged from 0 to 49.4 months with a mean ( + SD.) of 21.3 ( + 12.7) months and median of 22.7 months. Two-hundred-and-thirty-one of 391 ears with tubes were examined until the tubes had extruded. The time until the tubes extruded ranged from 1 week to 36.5 months with a mean ( + SD.) of 12.2 ( + 7.47) months. The time for the resulting tympanic membrane perforations to close ranged from 1 week to 21.0 months with a mean ( f SD.) of 5.36 ( ? 3.89) months. Table 3 Additional surgical procedures Within study period Adenoidectomy Tonsillectomy & adenoidectomy Frenulectomy Cleft palate repair Cleft lip repair Endoscopic ethmoidectomy Dilatation of nose Excision of preauricular cyst Tympanomastoidectomy Ossicular reconstruction Myringotomy alone Otoplasty Bilateral myringotomies & tubes Myringotomy & tube
54 35 1 2 0 I I I 0 0 2 0
Outside study period
,Y.A. Goldstein et ul. / ht. J. Prdiutr. Table 4 Concomitant
93
Otorlrit1oltrr:~~~/~~~l.34 (IY9h) 87 -49
medical problems
Cerebral palsy Developmental delay Profound sensorineural hearing loss S:P* meningitis S:P rubella Unknown etiology Trisomy 21 Trisomy I3 Crit du chat Binder’s syndrome Asthma Insulin dependent diabetes mellitus HIV positive Hypertension PPD positive Seizure disorder
2 4 I I I I I I I 3 2 I I I
Sickle cell disease S:P meningitis SP Viral encephalitis Renal agenesis Glaucoma Aural atresia & hemifacial microsomia Facial hemangioma Submental dermoid hbromalacia Pulmonic stenosrs S P mastoiditis Chronic sinusitis Cholesteatoma Recurrent tonsillitis Central sleep apnea Obstructive sleep apnea
I 3 I I I
*S/P, status post.
A summary of the complications of myringotomy tubes is presented in Table 5. The results are subdivided for children younger and older than the median age of 4 years and for children who underwent a concomitant adenoidectomy. The complication rates in children who underwent a concomitant adenoidectomy were similar to the overall complication rates. Three ears (1.14%) had permanent perforations. One perforation was present for 29.6 months, one for 40.7 months and one for 10 months. Thirty (11.1%) ears developed tympanosclerosis. Older children had a higher incidence of tympanosclerosis than younger children. No patient developed either a chronic retraction or a cholesteatoma. Six ears (1.70% of the 352 ears examined in the immediate postoperative period) developed otorrhea within 2 weeks of surgery. Thirty-five patients had at least one episode of otorrhea outside of the perioperative period and a total of 60 episodes occurred during the study period (19.6% of the 306 ears that were examined for at least 7 months in clinic). Younger children had a higher incidence of otorrhea than older children. All resolved with medical therapy except for one child who required removal of the tube in the operating room. Six ears (1.96% of the 306 ears with at least 7 months of clinic follow-up) developed granulation tissue around the tube in association with intermittent otorrhea. In two patients, the granulation tissue resolved with topical antimicrobial drops. Two patients had the affected tubes removed in the operating room with subsequent disappearance of the granulation tissue. One patient had the granulation tissue removed in the operating room and one child was lost to follow-up after being prescribed topical drops for treatment of his granulation tissue. In one child, the tube fell in the middle ear in the presence of recalcitrant purulent otorrhea, and she required myringotomy and tube removal in the
of myringotomy
*Postop, postoperative.
Entire patient population # Ears Incidence (‘A,) Children < 4 # ears Incidence (‘%I) Children > 4 # ears Incidence (‘A,) Children with concomitant adenoidectomy # ears Incidence (“A;,)
Table 5 Complications
30 Il.1 5 4.17 25 16.7 I7 14.5
2 1.68
I 0.69
2 I .I9
Tympano sclerosis
3 I.14
Permanent Perforation
tubes
0 0
0 0
0 0
0 0
Cholesteatoma
0 0
0 0
0 0
0 0
Chronic Retraction
3 1.96
2 I.01
4 2.61
6 1.70
postop* otorrhed
28 21.5
II 6.40
49 35.6
60 19.6
Episodes otorrhea
3 2.31
3 1.74
3 2.24
6 1.96
Granulation
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operating room and treatment with intravenous antibiotics. Thus, a total of four tubes were removed in the operating room because of tube complications. In addition, two children had their tubes removed because their otitis resolved. The audiograms of five patients were not analyzed because of known prior sensorineural hearing loss. Of the remaining 160 patients, 150 had audiograms prior to the insertion of tympanostomy tubes, and the mean PTA was 25.0 dB. One-hundred-and-twenty-one patients had audiograms with tubes in place, and the mean PTA was 2.44 dB. Only 61 patients had audiograms after the last set of tubes extruded and the mean PTA was 6.97 dB. Average follow-up for this group was 28.6 months. The audiograms of these 61 patients prior the insertion of tympanostomy tubes (mean + SD. PTA of 27.1 + 11.OdB) and with tubes in place (mean + S.D. PTA of 2.36 f 7.27 dB) were typical of the entire group who had audiograms, so these 61 patients do not represent a favored subset. These 61 patients were also subdivided into a group with normal tympanic membranes and type A tympanograms, and a group with either an effusion on exam or type B tympanograms, known ossicular discontinuity or prior mastoid surgery. The mean PTA of the patients with ‘healthy’ ears was 2.00 dB as compared to a mean PTA of 20.6 dB for the patients with continued pathology. A summary of the results is presented in Table 6.
Table 6 Hearing loss and tympanostomy tubes
# Patients with audios
Prior to M & T*
With tubes After tubes extruded
150
121
61 Entire group
PTAb Range (dB) Mean k SD. (dB) # Patients with PTA > 20 dB o/ Patients with PTA > 20 dB Follow-up Range (mo.) Mean k S.D. (mo.)
45 ‘Healthy’” Ears
16 Ears with pathology**
O-20 2.00 * 5.37 0
O-40 20.6 & 10.6 6
9.84
0
31.5
9.43-49.4 28.6 + 9.98
9.43-49.4 28.0 + 10.1
21.4-42.2 31.4 + 7.10
O-60 25.0 T 12.4 86
O-40 O-40 2.44 rt 7.19 6.97 k 10.9 6 3
57.3
2.48
-
*M & T, myringotomy & tube. “,**‘Healthy’ ears are those without effusion, known ossicular discontinuity or a history of prior mastoid surgery while ears with pathology have one of these 3 conditions. bPTA, pure tone average.
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34 (1996) 87-99
4. Discussion tubes While numerous efficacy studies have shown a role for both tympanostomy and antibiotic prophylaxis in the treatment of recurrent AOM and GM& prior work has shown that compliance with prophylactic antibiotics is poor in our urban, clinic population. In addition to prophylaxis for chronic otitis media compliance with other medical regimens has been shown to be lower in indigent populations. Only 18% of children in a Syracuse clinic completed a 10 day course of penicillin for acute pharyngitis [5] as compared to 56% of patients from a Rochester private practice [7]. A compliance rate of 49.1% was found for children treated for AOM in a Baltimore clinic with 40.7% of patients keeping their follow-up appointments [4]. Inner city hypertension patients have a much higher rate of non-compliance with drug therapy than other patient populations [lo]. Forty-four percent of pediatric seizure patients from an Atlanta clinic adhered to their medical regimen [15]. One-third of women of low socioeconomic status from several North Carolina clinics were non-compliant with referral for treatment of cervical dysplasia [20]. There is little data on postoperative complication rates in exclusively lower socioeconomic populations after minor surgical procedures. However, renal transplant patients from low income groups had a reduced rate of allograft survival at 5 years (76%) than patients from higher income groups (90%) and non-compliant patients had a reduced rate of graft survival at 5 years (76%) than compliant patients (89%), although both low income and non-compliance were independent risk factors [18]. Despite our concerns that there would be an increased complication rate in our urban pediatric clinic population, our results show that the incidence of complications with tympanostomy tubes is low. Therefore, myringotomy with insertion of middle ear ventilation tubes remains a reasonable treatment modality in an inner city population. When interpreting our data, it must be realized that a significant number of patients had only limited follow-up in clinic. 3.03% of patients had no follow-up after the insertion of tympanostomy tubes, 25.5% of patients had follow-up of < 1 year and 60.0% had follow-up of less than two years. The most poorly compliant patients are not represented in the findings and omission of complications from this group may have skewed the results. The incidence of myringotomy tube complications in our clinic population compares favorably and is often lower than complications reported by other authors (Table 1). Our lower rates of tympanic membrane perforation and otorrhea may be explained by our almost exclusive use of Armstrong grommet tubes which have lower reported incidences of these complications than long-term tubes such as T tubes [19,34]. It is difficult to interpret whether the use of postoperative topical polymyxin G sulfate-neomycin sulfate hydrocortisone drops influenced the incidence of postoperative otorrhea since our study was retrospective. There are mixed results in the literature for prospective studies of topical prophylaxis. Baker et al. [l] found that the use of topical gentamycin solution for 4 days postoperatively resulted in a highly significant reduction in the incidence of postoperative otorrhea within the first 2 weeks (19.6% for the control group versus 0% for the treated group). In contrast, the following studies did not find a statistically significant
N.A.
Goldstein
et al. I Int. J. Pediatr.
Otorhinolaryngol.
34 (1996)
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97
reduction in the incidence of postoperative otorrhea. Balkany et al. [3] compared 1 week of topical polymyxin-neomycin, 4 days of oral ampicillin and no therapy and found incidences of otorrhea of 6%, 13% and 19%, respectively within 4 weeks postoperatively. Epstein et al. [9] found that the use of 3 days of sulfacetamide/ prednisolone topical solution resulted in a 10.6% incidence of otorrhea within 1 week as compared to a 13.2% incidence in the control population. Scott et al. [27] found that the use of gentamycin otic solution in the operating room only, for 48 h postoperatively and no prophylaxis resulted in rates of otorrhea of 8.8%, 5.6% and 12% within 2 weeks. Our incidence of tympanosclerosis (11.1%) is lower than the incidences reported in prior studies (23.6-59.0%) which used both short and long-term tubes [17,2225,29,31-331. The development of post-intubation tympanosclerosis has been attributed to intratympanic membrane hemorrhage during myringotomy [24], the presence of a mucoid effusion at the time of myringotomy [29] and the length of time the tube is in place [23-25,291. Tympanosclerosis is not associated with significant hearing impairment [31,32]. It is unclear why our incidence of tympanosclerosis is so low. The higher rate of tympanosclerosis in our patients 4 years and older may be a reflection of the greater number of tubes and greater overall time the tubes have been in place in the older children. A prospective study using different types of myringotomy tubes would be needed to determine if the number and type of myringotomy tube influence the development of tympanosclerosis. Overall, hearing was better after the extrusion of the last set of tubes than prior to tube placement, and was normal (PTA I 20 dB) in all patients without further middle ear effusions. There was no case of neurosensory loss as a result of myringotomy tubes. 5. Conclusions
Our study shows that the incidence of complications of myringotomy tubes was low in our inner city, pediatric clinic population. We recommend myringotomy with insertion of tympanostomy tubes for the treatment of symptomatic refractory otitis media in children in an urban clinic. We specifically would advocate tube placement over antibiotic prophylaxis for children with hearing loss. References [I] Baker, S. and Chole, R.A. (1988) A randomized clinical trial of topical gentamycin after tympanostomy tube placement. Arch. Otolaryngol. Head Neck Surg. 114, 755-757. [2] Baldwin, R.L. and Aland, J. (1990) The effects of povidone-iodine preparation on the incidence of post-tympanostomy otorrhea. Otolaryngol. Head Neck Surg. 102 631-634. [3] Balkany, T.J., Barkin, R.M., Suzuki, B.H. and Watson W.J. (1983) A prospective study of infection following tympanostomy and tube insertion. Am. J. Otol. 4, 288291. [4] Becker, M.H., Drachman, R.H. and Kirscht, J.P. (1972) Predicting mothers’ compliance with pediatric medical regimens. J. Pediatr. 81, 842-854. [5] Bergman, A.B. and Werner, R.J. (1963) Failure of children to receive penicillin by mouth. N. Engl. J. Med. 268 133441338.
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[6] Bulkley, W.J., Bowes, A.K. and Marlowe, J.F. (1991) Complications following ventilation of the middle ear using Goode T tubes. Arch. Otolaryngol. Head Neck Surg. 117, 8955898. [7] Charney, E., Bynum, R., Eldredge, D., Frank, D. MacWhinney, J.B., McNabb, N., Scheiner, A., Sumpter, E.A. and Iker, H. (1967) How well do patients take oral penicillin? A collaborative study in private practice. Pediatrics 40 188- 195. [8] Debruyne, F., Jorissen, M. and Poelmans, J. (1988) Otorrhea during transtympanal ventilation. Am. J. Otol. 9 316-317. [9] Epstein, J.S., Beane, J. and Hubbell, R. (1992) Prevention of early otorrhea in ventilation tubes. Otolaryngol. Head Neck Surg. 107, 758-762. [IO] Francis, C.K. (1991) Hypertension, cardiac disease and compliance in minority patients. Am. J. Med. 91, Suppl. IA 29S36S. [II] Gates, G.A., Avery, C., Prihoda, T.J. and Holt, G.R. (1986) Post-tympanostomy otorrhea. Laryngoscope 96, 630-634. [12] Giebink, G.S., Daly, K., hrdn, D.J., Satz, M. and Ayre, T. (1992) Predictors for postoperative otorrhea following tympanostomy tube insertion. Arch. Otolaryngol. Head Neck Surg. 118, 491-494. [13] Goldstein, N.A. and Sculerati, N. (1994) Compliance with prophylactic antibiotics for otitis media in a New York City clinic. Int. J. Pediatr. Otorhinolaryngol. 28, 129-140. [14] Hawthorne, M.R. and Parker, A.J. (1988) Perforations of the tympanic membrane following the use of Goode-type ‘long term’ tympanostomy tubes. J. Laryngol. Otol. 102, 997-999. [15] Hazzard, A., Hutchinson, S.J. and Krawiecki, N. (1990) Factors related to adherence to medication regimens in pediatric seizure patients, J. Pediatr. Psychol. 15, 5433555. [16] Hilding, D.A. and Ammerman, S. (1986) Tympanostomy tube complications and efficacy in children of a rural community. West. J. Med. 144, 3188320. [I71 Hughes, L.A. and Wight, D. (1988) Tympanostomy tubes: long-term effects. A.F.P. 38, 1866190. [I81 Kalil, R.S.N., Heim-Duthoy, K.L. and Kasiske, B.L. (1992) Patients with a low income have a reduced renal allograft survival. Am. J. Kidney Dis. 20, 63369. [19] Khngensmith, M.R., Strauss, M. and Conner, G.H. (1985) A comparison of retention and complication rates of large-bore (Paparella II) and small-bore middle ear ventilating tubes. Otolaryngol. Head Neck Surg. 93, 322-330. [20] Laedtke, T.W. and Dignan, M. (1992) Compliance with therapy for cervical dysplasia among women of low socioeconomic status. South. Med. J. 85, 5-8. [21] Luxford, W.M. and Sheehy, J.L. (1982) Myringotomy and ventilation tubes: a report of 1568ears. Laryngoscope 92 1293-1297. [22] Mangat, K.S., Morrison, G.A.J. and Ganniwalla, T.M. (1993) T-tubes: a retrospective review of 1274 insertions over a 4-year period. Int. J. Pediatr. Otorhinolaryngol. 25, 119-125. [23] Maw, A.R. (1991) Development of tympanosclerosis in children with otitis media with effusion and ventilation tubes. J. Laryngol. Otol. 105, 614-617. [24] Parker, A.J., Maw, A.R. and Powell, J.E. (1990) Intra-tympanic membrane bleeding after grommet insertion and tympanosclerosis. Clin. Otolaryngol. 15, 203-207. [25] Pichichero, M.E., Berghash, L.R. and Hengerer, A.S. (1989) Anatomic and audiologic sequelae after tympanostomy tube insertion or prolonged antibiotic therapy for otitis media. Pediatr. Infect. Dis. J. 8, 780-787. [26] Prichard, A.J.N., Marshall, J., Skinner, D.W. and Narula, A.A. (1992) Long-term results of Goode’s tympanostomy tubes in children. Int. J. Pediatr. Otorhinolaryngol. 24 2277233. [27] Scott, B.A. and Strunk, CL. (1992) Post-tympanostomy otorrhea: a randomized clinical trial of topical prophylaxis. Otolaryngol. Head Neck Surg. 106, 34-41. 1281Scott, B.A. and Strunk, CL. (1992) Post-tympanostomy otorrhea: the efficacy of canal preparation. Laryngoscope 102 1103-l 107. [29] Slack, R.W.T., Maw, A.R., Capper, J.W.R. and Kelly, S. (1984) Prospective study of tympanosclerosis developing after grommet insertion. J. Laryngol. Otol. 98, 771-774. [30] Solomon, P.R., Lax, M.J. and Smitheringale, A.J. (1993) Tympanic membrane perforation following ventilation tube removal in a pediatric setting: a historical study. J. Otolaryngol. 22, 48-49.
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99
[31] Tos, M., Bonding, P. and Pot&en, G. (1983) Tympanosclerosis of the drum in secretory otitis after insertion of grommets: a prospective, comparative study. J. Laryngol. Otol. 97, 4899496. [32] Tos, M. and Stangerup, S-E. (1989) Hearing loss in tympanosclerosis caused by grommets, Arch. Otolaryngol. Head Neck Surg. I IS, 931-935. [33] Von Schoenberg, M., Wengraf, C.L. and Gleeson, M. (1989) Results of middle ear ventilation with Goode’s tubes. Clin. Otolaryngol. 14, 503-508. [34] Weigel, M.T., Parker, M.Y., Goldsmith, M.M., Postma D.S. and Pillsbury, H.C. (1989) A prospective randomized study of four commonly used tympanostomy tubes. Laryngoscope 99 2522256. [35] Yanagihara, N. and Yagi, T. (1985) Limitation of long-term ventilation tube: in view of complications and hearing restoration, Auris Nasus Larynx I2 (Suppl. I). 2444246.
ELSEVIER
Complications
14 (199h) x7-99
of tympanostomy tubes in an inner city clinic population
Nira A. Goldstein’,
J. Thomas Roland Jr.*2, Nancy Sculerati
Drpurtnwnt of‘ Otolaryngology, New York Uniwrsity School qf Medicine. 550 First Armur. Nm York, NY 10016. USA Received 13 March 1995; revision received 30 June 1995: accepted 6 July 1995
Abstract While both prophylactic antibiotics and tympanostomy tube insertion have a role in the treatment of recurrent acute otitis media (AOM) and otitis media with effusion (OME) in children previous work has shown that patients in our urban clinic are not compliant with prophylactic antibiotics. Concerned about the potential for decreased compliance in a non-compliant population, we performed a retrospective review to assess the incidence of complications from the insertion of tympanostomy tubes in the same pediatric clinic population. A total of 391 tubes were placed in 165 patients. Follow-up ranged from O-49.4 months with a mean of 21.3 months. Three ears (1.14%) had persistent perforations. Tympanosclerosis was found in 30 ears (ll.l’%). No ear showed a chronic retraction or cholesteatoma. Six ears (1.70%) developed postoperative otorrhea. Thirty-five patients had at least one episode of otorrhea outside of the perioperative period, and a total of 60 episodes (19.6% of ears) occurred during the study period. The mean pure tone average prior to tube placement was 25.0 dB, with tubes in place was 2.44 dB and after the last set of tubes had extruded was 6.97 dB. Our study shows that the incidence of complications of tympanostomy tubes was minimal in our inner city clinic population. Keywords: Tympanostomy sis; Otorrhea
tubes; Compliance;
Complications;
Perforation;
Tympanosclero-
* Corresponding author. ’ Kecipient of the 1995 Charles F. Ferguson Award, American Society of Pediatric Otolaryngology. ’ Presented at the 10th annual meeting of the American Society of Pediatric Otolaryngology, Durango, CO, May 1995 0165-5876;96/$09.50 0 1996 Elsevier Science Ireland Ltd. All rights reserved SSDI 0165.5876(95)01259-E
Inc.,
88
N.A. Goldstein et al. / Int. J. Pediatr. Otorhinolaryngol.
34 (1996) 87-99
1. Introduction The treatment of recurrent acute otitis media (AOM) and otitis media with effusion (OME) in children most often involves either chemoprevention with prophylactic antibiotics or the insertion of tympanostomy tubes. Previous work at our institution showed that at least 53% of families in our urban clinic were non-compliant with prophylactic antibiotic treatment. We advocated that a recommendation for a surgical drainage procedure should therefore be considered for our patient population with problematic otitis media rather than assuming that antibiotic prophylaxis would have the same efficacy as compared to other, more compliant populations [13]. Although the insertion of middle ear ventilation tubes has been shown to have efficacy with a low rate of complications in compliant populations, we were concerned that the actual rate of complications might be higher in our group of patients. A summary of reported incidences of complications of myringotomy tubes is presented in Table 1. No prior study has analyzed complications in an inner city, indigent population. Since compliance with postoperative clinic visits, postoperative water precautions and possible treatment of subsequent otorrhea in this patient population may be poor, tympanostomy tube sequelae may be more severe than in patient populations studied previously. Some study groups have been composed of patients from a private practice [6,12,17,25]. In other studies, patients were recruited to enter a prospective study [l-3,9,1 1,12,23,24,2729,31,34]. Since organized follow-up was arranged for these patients, complication rates may not reflect those in a clinic population. One study analyzed complications in a rural population [16]. Many studies do not discuss the characteristics of the patient population [8,14,19,21,22,26,30,32,33,35].We performed a retrospective review to investigate the incidence of complications in our pediatric urban clinic population. 2. Materials and methods All charts from the Pediatric Otolaryngology Clinic of children who underwent myringotomy with placement of a tympanostomy tube between 21 June 1990 and 13 August 1992 at Bellevue Hospital were retrospectively reviewed. All patients were included in the study. Many of the children had prior sets of myringotomy tubes or additional tubes placed at another institution, but the complications associated with these tubes were not studied. Additional tubes placed between 14 August 1992 and 12 April 1994 in this patient group were included in the analysis. All procedures were performed in the general operating room under general anesthesia, either as an inpatient or on an ambulatory basis depending on whether additional procedures were performed and the medical condition of the patient. Antiseptic preparation of the external auditory canals was not performed. Specific
N.A. Goldstein et ul. ! Int. J. Pediatr. Otorhinolaryngol. Table 1 Literature
review of complications
Author
Tube type
Present Baker [I] Baldwin [2] Balkany [3] Bulkley [6] Debruyne [8] Epstein [9] Gates [l I] Giebink [ 121
Hawthorne [I41 Hilding [16] Hughes [17] Klingensmith
[I91
Luxford
[21]
Mangat [22] Maw [23] Parker [24] Pichichero [25]
Prichard [26] Scott [27] Scott [28] Slack [29] Solomon [30] Tos [31] Tos [32] Von Schoenberg [33] Weigel [34]
Yanagihard
[35]
Armstrong T-tube & grommet Sheehy. Collar button Sheehy Goode T-tube Grommet Donaldson Shepard Donaldson, Robin, Shepard, Reuter Goode T-tube Goode T-tube, Arrow Unknown Paparella I, Pdparella II. Shepard, Armstrong Collar button, Per-Lee, Mesh Goode T-tube Unknown Shepard Armstrong, Collar button, Goode T-tube Goode T-tube Armstrong Armstrong Shepard Shepard, Armstrong Grommet Grommet Goode T-tube Goode T-tube. Armstrong Shepard, Reuter-Bobbin Goode T-tube
of myringotomy Permanent perforation 1.14
((!I)
tubes Cholesteatoma Tympanosclerosis (‘%I) (‘%I)
Chronic retraction
11.1
0
0
0
7.1 -
15.6 1.6 42.1 2.771 1.8
0.83
4.0 32.0
23.6 48.6 40.2 52.3
21.1
.-. 40.0 -
10.3
47.5 0 12
89
34 (1996) 87-99
48.0 59.0 36.0
14.6 0
0
(‘%I)
90
N.A. Goldstein et al. / Int. J. Pediatr. Otorhinolaryngol. 34 (1996) 87-99
Table 1 (continued) Author
Tube type
postop* otorrhea (%)
Episodes otorrhea (%)
Granulation
Present
Armstrong
1.70
19.6
1.96
Baker [l]
T-tube & grommet Sheehy, Collar Button Sheehy Goode T-tube Grommet
o- 19.0
Baldwin [2] Balkany [3] Bulkley [6] Debruyne [S] Epstein [9] Gates [ 111 Giebink [12]
Donaldson Shepard
Donaldson, Bobbin, Shepard, Reuter Hawthorne [14] Goode T-tube Hilding [16] Goode T-tube, Arrow Unknown Hughes [17] Klingensmith Paparella I, Paparella II, 1191 Shepard, Armstrong Collar Button, Luxford [21] Per-Lee, Mesh Mangat [22] Goode T-tube Unknown Maw [23] Parker [24] Pichichero [25]
Prichard [26] Scott [27] Scott [28] Slack [29] Solomon [30] Tos [31] Tos [32]
(%) Hearing loss after tubes extruded 9.84% with PTA** > 20 dB 0% neurosensory loss
6.3-10.0 12.0 -
7.1 10.4
0% neurosensory loss
11.9 3.4 11.0
-
41.0
-
3.8% with sound field >20 dB 0% neurosensory loss
O-31.8
~
19.0
-
21.0
21.0
-
Shepard Armstrong, Collar Button, Goode T-tube Goode T-tube Armstrong Armstrong Shepard
9.3-18.7% 20 dB 8.7 9.8
54.9
-
Shepard, Armstrong Grommet Grommet
Goode T-tube Von Schoenberg [33] Goode T-tube, Wiegel [34] Armstrong, Shepard, Reuter-Bobbin Yanagihara [35] Goode T-tube
with threshold>
Hearing impairment < 0.5 dB in ears with tympanosclerosis -
70.4
-
O-50.0
-
29.0
*Postop, postoperative, **PTA, pure tone average.
12.3
N.A. Goldstein et al. 1 Int. J. Pediatr. Otorhinolaryngol.
34 (1996) 87-99
91
technique of myringotomy varied but usually a radial incision was made in either the anteroinferior or posteroinferior quadrant. A fluoroplastic modified Armstrong bevelled grommet tube was placed in all cases except one in which a Goode T tube was placed. All procedures were performed by residents under attending supervision. Children were routinely given 3 days of topical polymyxin G sulfate-neomycin sulfate hydrocortisone otic suspension postoperatively, but systemic antibiotics were not given unless concomitant tonsillectomy and/or adenoidectomy or cleft palate repair were performed. For each tube placed, data collected included the age of the patient, the indication for the procedure, whether chemoprophylaxis had been attempted and any concomitant procedures such as adenoidectomy, tonsillectomy or cleft palate repair performed. The patient’s subsequent clinic follow-up was also recorded. Ears were examined by residents under the supervision of the senior author, a validated otoscopist. The time until tube extrusion was defined as the time between the insertion date and halfway between the time the tube was seen in the tympanic membrane in clinic and the time it was not seen. The time for the resulting perforations to heal was defined as halfway between the time the tube was last seen in the tympanic membrane in clinic or the time a perforation was first seen and the time an intact tympanic membrane was first seen in clinic. The time until tube extrusion and the time for the resulting perforations to heal were analyzed for the ears of all patients who had sufficient follow-up in clinic such that they were examined until their tubes had extruded. The number of ears which developed permanent perforations, tympanosclerosis, chronic retractions or cholesteatoma were recorded for this patient group. Tympanosclerosis was also seen in several patients who did not follow up in clinic until the tubes had extruded; these ears were also included in the total number of ears with tympanosclerosis. The number of episodes of immediate postoperative (within 2 weeks) otorrhea was recorded from the total number of ears that were examined in the immediate postoperative period. All ears that were examined for at least 7 months postoperatively were included in the analysis of otorrhea outside of the immediate postoperative period and in the analysis of the development of granulation surrounding the tube. The time period of 7 months was chosen arbitrarily. Audiometric data consisting of the pure tone average (PTA) of 500, 1000 and 2000 Hz were recorded for all patients with audiograms prior to tube placement, with tubes in place and after the last tube had extruded. Audiograms consisted of both sound field and play audiometry depending on the age and willingness of the patient. 3. Results During the study period, a total of 391 tubes were placed in 165 patients. Two-hundred-and-nine procedures were performed: 182 bilateral myringotomies with tube placement and 27 unilateral myringotomy with tube placement. The
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34 (1996) 87-99
Table 2 Patient demographics Sex
Age
Race
Male 90 Female 75
Range 9 mo. to 14 years Mean 4.6 years
Caucasian 12 Hispanic 131 Black 12 East Asian 4 East Indian 6
mean number of procedures per patient was 1.27, and the mean number of tubes per patient was 2.37 (range l-6). The demographics of the patient population are presented in Table 2. Many children had additional tubes placed either prior to the study period or at another institution or had additional either concomitant or separate surgical procedures (Table 3). Numerous medical problems were also found in the patient population (Table 4). Prophylaxis for chemoprevention of otitis media was used preoperatively in 73 of the patients. Of the 391 tubes placed 217 were placed for treatment of recurrent AOM (106 bilateral myringotomies and tubes, 5 myringotomies and tubes) and 174 were placed for treatment of OME (76 bilateral myringotomies and tubes, 22 myringotomies and tubes). Patient follow-up in clinic ranged from 0 to 49.4 months with a mean ( + SD.) of 21.3 ( + 12.7) months and median of 22.7 months. Two-hundred-and-thirty-one of 391 ears with tubes were examined until the tubes had extruded. The time until the tubes extruded ranged from 1 week to 36.5 months with a mean ( + SD.) of 12.2 ( + 7.47) months. The time for the resulting tympanic membrane perforations to close ranged from 1 week to 21.0 months with a mean ( f SD.) of 5.36 ( ? 3.89) months. Table 3 Additional surgical procedures Within study period Adenoidectomy Tonsillectomy & adenoidectomy Frenulectomy Cleft palate repair Cleft lip repair Endoscopic ethmoidectomy Dilatation of nose Excision of preauricular cyst Tympanomastoidectomy Ossicular reconstruction Myringotomy alone Otoplasty Bilateral myringotomies & tubes Myringotomy & tube
54 35 1 2 0 I I I 0 0 2 0
Outside study period
,Y.A. Goldstein et ul. / ht. J. Prdiutr. Table 4 Concomitant
93
Otorlrit1oltrr:~~~/~~~l.34 (IY9h) 87 -49
medical problems
Cerebral palsy Developmental delay Profound sensorineural hearing loss S:P* meningitis S:P rubella Unknown etiology Trisomy 21 Trisomy I3 Crit du chat Binder’s syndrome Asthma Insulin dependent diabetes mellitus HIV positive Hypertension PPD positive Seizure disorder
2 4 I I I I I I I 3 2 I I I
Sickle cell disease S:P meningitis SP Viral encephalitis Renal agenesis Glaucoma Aural atresia & hemifacial microsomia Facial hemangioma Submental dermoid hbromalacia Pulmonic stenosrs S P mastoiditis Chronic sinusitis Cholesteatoma Recurrent tonsillitis Central sleep apnea Obstructive sleep apnea
I 3 I I I
*S/P, status post.
A summary of the complications of myringotomy tubes is presented in Table 5. The results are subdivided for children younger and older than the median age of 4 years and for children who underwent a concomitant adenoidectomy. The complication rates in children who underwent a concomitant adenoidectomy were similar to the overall complication rates. Three ears (1.14%) had permanent perforations. One perforation was present for 29.6 months, one for 40.7 months and one for 10 months. Thirty (11.1%) ears developed tympanosclerosis. Older children had a higher incidence of tympanosclerosis than younger children. No patient developed either a chronic retraction or a cholesteatoma. Six ears (1.70% of the 352 ears examined in the immediate postoperative period) developed otorrhea within 2 weeks of surgery. Thirty-five patients had at least one episode of otorrhea outside of the perioperative period and a total of 60 episodes occurred during the study period (19.6% of the 306 ears that were examined for at least 7 months in clinic). Younger children had a higher incidence of otorrhea than older children. All resolved with medical therapy except for one child who required removal of the tube in the operating room. Six ears (1.96% of the 306 ears with at least 7 months of clinic follow-up) developed granulation tissue around the tube in association with intermittent otorrhea. In two patients, the granulation tissue resolved with topical antimicrobial drops. Two patients had the affected tubes removed in the operating room with subsequent disappearance of the granulation tissue. One patient had the granulation tissue removed in the operating room and one child was lost to follow-up after being prescribed topical drops for treatment of his granulation tissue. In one child, the tube fell in the middle ear in the presence of recalcitrant purulent otorrhea, and she required myringotomy and tube removal in the
of myringotomy
*Postop, postoperative.
Entire patient population # Ears Incidence (‘A,) Children < 4 # ears Incidence (‘%I) Children > 4 # ears Incidence (‘A,) Children with concomitant adenoidectomy # ears Incidence (“A;,)
Table 5 Complications
30 Il.1 5 4.17 25 16.7 I7 14.5
2 1.68
I 0.69
2 I .I9
Tympano sclerosis
3 I.14
Permanent Perforation
tubes
0 0
0 0
0 0
0 0
Cholesteatoma
0 0
0 0
0 0
0 0
Chronic Retraction
3 1.96
2 I.01
4 2.61
6 1.70
postop* otorrhed
28 21.5
II 6.40
49 35.6
60 19.6
Episodes otorrhea
3 2.31
3 1.74
3 2.24
6 1.96
Granulation
N.A. Goldstein et al. / Int. J. Pediatr. Otorhinolaryngol.
95
34 (1996) 87-99
operating room and treatment with intravenous antibiotics. Thus, a total of four tubes were removed in the operating room because of tube complications. In addition, two children had their tubes removed because their otitis resolved. The audiograms of five patients were not analyzed because of known prior sensorineural hearing loss. Of the remaining 160 patients, 150 had audiograms prior to the insertion of tympanostomy tubes, and the mean PTA was 25.0 dB. One-hundred-and-twenty-one patients had audiograms with tubes in place, and the mean PTA was 2.44 dB. Only 61 patients had audiograms after the last set of tubes extruded and the mean PTA was 6.97 dB. Average follow-up for this group was 28.6 months. The audiograms of these 61 patients prior the insertion of tympanostomy tubes (mean + SD. PTA of 27.1 + 11.OdB) and with tubes in place (mean + S.D. PTA of 2.36 f 7.27 dB) were typical of the entire group who had audiograms, so these 61 patients do not represent a favored subset. These 61 patients were also subdivided into a group with normal tympanic membranes and type A tympanograms, and a group with either an effusion on exam or type B tympanograms, known ossicular discontinuity or prior mastoid surgery. The mean PTA of the patients with ‘healthy’ ears was 2.00 dB as compared to a mean PTA of 20.6 dB for the patients with continued pathology. A summary of the results is presented in Table 6.
Table 6 Hearing loss and tympanostomy tubes
# Patients with audios
Prior to M & T*
With tubes After tubes extruded
150
121
61 Entire group
PTAb Range (dB) Mean k SD. (dB) # Patients with PTA > 20 dB o/ Patients with PTA > 20 dB Follow-up Range (mo.) Mean k S.D. (mo.)
45 ‘Healthy’” Ears
16 Ears with pathology**
O-20 2.00 * 5.37 0
O-40 20.6 & 10.6 6
9.84
0
31.5
9.43-49.4 28.6 + 9.98
9.43-49.4 28.0 + 10.1
21.4-42.2 31.4 + 7.10
O-60 25.0 T 12.4 86
O-40 O-40 2.44 rt 7.19 6.97 k 10.9 6 3
57.3
2.48
-
*M & T, myringotomy & tube. “,**‘Healthy’ ears are those without effusion, known ossicular discontinuity or a history of prior mastoid surgery while ears with pathology have one of these 3 conditions. bPTA, pure tone average.
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34 (1996) 87-99
4. Discussion tubes While numerous efficacy studies have shown a role for both tympanostomy and antibiotic prophylaxis in the treatment of recurrent AOM and GM& prior work has shown that compliance with prophylactic antibiotics is poor in our urban, clinic population. In addition to prophylaxis for chronic otitis media compliance with other medical regimens has been shown to be lower in indigent populations. Only 18% of children in a Syracuse clinic completed a 10 day course of penicillin for acute pharyngitis [5] as compared to 56% of patients from a Rochester private practice [7]. A compliance rate of 49.1% was found for children treated for AOM in a Baltimore clinic with 40.7% of patients keeping their follow-up appointments [4]. Inner city hypertension patients have a much higher rate of non-compliance with drug therapy than other patient populations [lo]. Forty-four percent of pediatric seizure patients from an Atlanta clinic adhered to their medical regimen [15]. One-third of women of low socioeconomic status from several North Carolina clinics were non-compliant with referral for treatment of cervical dysplasia [20]. There is little data on postoperative complication rates in exclusively lower socioeconomic populations after minor surgical procedures. However, renal transplant patients from low income groups had a reduced rate of allograft survival at 5 years (76%) than patients from higher income groups (90%) and non-compliant patients had a reduced rate of graft survival at 5 years (76%) than compliant patients (89%), although both low income and non-compliance were independent risk factors [18]. Despite our concerns that there would be an increased complication rate in our urban pediatric clinic population, our results show that the incidence of complications with tympanostomy tubes is low. Therefore, myringotomy with insertion of middle ear ventilation tubes remains a reasonable treatment modality in an inner city population. When interpreting our data, it must be realized that a significant number of patients had only limited follow-up in clinic. 3.03% of patients had no follow-up after the insertion of tympanostomy tubes, 25.5% of patients had follow-up of < 1 year and 60.0% had follow-up of less than two years. The most poorly compliant patients are not represented in the findings and omission of complications from this group may have skewed the results. The incidence of myringotomy tube complications in our clinic population compares favorably and is often lower than complications reported by other authors (Table 1). Our lower rates of tympanic membrane perforation and otorrhea may be explained by our almost exclusive use of Armstrong grommet tubes which have lower reported incidences of these complications than long-term tubes such as T tubes [19,34]. It is difficult to interpret whether the use of postoperative topical polymyxin G sulfate-neomycin sulfate hydrocortisone drops influenced the incidence of postoperative otorrhea since our study was retrospective. There are mixed results in the literature for prospective studies of topical prophylaxis. Baker et al. [l] found that the use of topical gentamycin solution for 4 days postoperatively resulted in a highly significant reduction in the incidence of postoperative otorrhea within the first 2 weeks (19.6% for the control group versus 0% for the treated group). In contrast, the following studies did not find a statistically significant
N.A.
Goldstein
et al. I Int. J. Pediatr.
Otorhinolaryngol.
34 (1996)
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97
reduction in the incidence of postoperative otorrhea. Balkany et al. [3] compared 1 week of topical polymyxin-neomycin, 4 days of oral ampicillin and no therapy and found incidences of otorrhea of 6%, 13% and 19%, respectively within 4 weeks postoperatively. Epstein et al. [9] found that the use of 3 days of sulfacetamide/ prednisolone topical solution resulted in a 10.6% incidence of otorrhea within 1 week as compared to a 13.2% incidence in the control population. Scott et al. [27] found that the use of gentamycin otic solution in the operating room only, for 48 h postoperatively and no prophylaxis resulted in rates of otorrhea of 8.8%, 5.6% and 12% within 2 weeks. Our incidence of tympanosclerosis (11.1%) is lower than the incidences reported in prior studies (23.6-59.0%) which used both short and long-term tubes [17,2225,29,31-331. The development of post-intubation tympanosclerosis has been attributed to intratympanic membrane hemorrhage during myringotomy [24], the presence of a mucoid effusion at the time of myringotomy [29] and the length of time the tube is in place [23-25,291. Tympanosclerosis is not associated with significant hearing impairment [31,32]. It is unclear why our incidence of tympanosclerosis is so low. The higher rate of tympanosclerosis in our patients 4 years and older may be a reflection of the greater number of tubes and greater overall time the tubes have been in place in the older children. A prospective study using different types of myringotomy tubes would be needed to determine if the number and type of myringotomy tube influence the development of tympanosclerosis. Overall, hearing was better after the extrusion of the last set of tubes than prior to tube placement, and was normal (PTA I 20 dB) in all patients without further middle ear effusions. There was no case of neurosensory loss as a result of myringotomy tubes. 5. Conclusions
Our study shows that the incidence of complications of myringotomy tubes was low in our inner city, pediatric clinic population. We recommend myringotomy with insertion of tympanostomy tubes for the treatment of symptomatic refractory otitis media in children in an urban clinic. We specifically would advocate tube placement over antibiotic prophylaxis for children with hearing loss. References [I] Baker, S. and Chole, R.A. (1988) A randomized clinical trial of topical gentamycin after tympanostomy tube placement. Arch. Otolaryngol. Head Neck Surg. 114, 755-757. [2] Baldwin, R.L. and Aland, J. (1990) The effects of povidone-iodine preparation on the incidence of post-tympanostomy otorrhea. Otolaryngol. Head Neck Surg. 102 631-634. [3] Balkany, T.J., Barkin, R.M., Suzuki, B.H. and Watson W.J. (1983) A prospective study of infection following tympanostomy and tube insertion. Am. J. Otol. 4, 288291. [4] Becker, M.H., Drachman, R.H. and Kirscht, J.P. (1972) Predicting mothers’ compliance with pediatric medical regimens. J. Pediatr. 81, 842-854. [5] Bergman, A.B. and Werner, R.J. (1963) Failure of children to receive penicillin by mouth. N. Engl. J. Med. 268 133441338.
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