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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 23  |  Issue : 3  |  Page : 146-150

Comparative assessment of grommets with topical intranasal steroid in cases of otitis media with effusion


Department of ENT, MGIMS, Wardha, Maharashtra, India

Date of Web Publication31-Aug-2017

Correspondence Address:
Sushil Suresh Chavan
Department of ENT, MGIMS, Sewagram, Wardha, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/indianjotol.INDIANJOTOL_46_17

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  Abstract 

Aim: This study of 56 patients is to assess the effectiveness of grommet insertion compared with non-surgical treatment steroids (topical intranasal) in otitis media effusion (OME) cases and study complications related to the grommet and topical intranasal steroid. Material: A total subjects of various age groups attending out patient department of ENT, Kasturba Hospital, MGIMS Sevagram, Hospital, Wardha from june 2013 to august 2015 who meet the inclusion criteria and give their written consent in local language will be included in the study. Method: Comparison of medical and surgical management were done. Medical management include topical intranasal steroids by Mometasone fuorate. The recommended dose for treatment of the nasal symptoms is 1 spray (50 microgram of mometasone furoate in each spray). Recommended duration of spray is 2 to 4 weeks and the stated achievement of effect of spray is approximately 1 to 2 weeks. Surgical management include myringotomy with grommet insertion. Generally, myringotomy is performed in conjunction with the insertion of a polyethylene tube called as grommet. Infants and small children are best managed by performing this procedure under a general anesthetic. In older children and adults, local anesthetic can be used as a single block in posterior canal wall so as it block Arnold“s nerve. Results: From this present study cases of children 10 (47.62%) patients shows improvement and 17 (48.57%) adult patient shows improvement having minimal difference. Similarly failure of treatment in children is 1 (4.76%) complications in 2 (9.52%) and in adult patients 0 (0%) complication in 2 (5.71%) it was not showing significant differences. p value was not significant and showing that the differences in value was not having any level of significance in same group. It is concluded that topical nasal steroids are not so effective as surgical drainage of exudative material (myringotomy). Conclusion: Use of steroid causes nasal irritation and temporary relief only and in some patient causes only retention of fluid. Sometimes grommet retained in tympanic membrane and not extruded out needed manual removel. Beside that Overall results are in the favour of myringotomy with grommet insertion as a better modality.

Keywords: Grommet, intranasal steroids, myringotomy, otitis media effusion


How to cite this article:
Chavan SS, Nagpure PS. Comparative assessment of grommets with topical intranasal steroid in cases of otitis media with effusion. Indian J Otol 2017;23:146-50

How to cite this URL:
Chavan SS, Nagpure PS. Comparative assessment of grommets with topical intranasal steroid in cases of otitis media with effusion. Indian J Otol [serial online] 2017 [cited 2017 Oct 22];23:146-50. Available from: http://www.indianjotol.org/text.asp?2017/23/3/146/213868


  Introduction Top


Otitis media with effusion (OME) or glue ear is very common in children, especially between the age of 1 and 3 years with the prevalence of 10%–30% and a cumulative incidence of 80% at the age of 4 years but always shows incidence in various age groups. OME is defined as middle ear effusion without signs or symptoms of an acute infection; OME is the chronic accumulation of mucus within the middle ear and sometimes the mastoid air cell system as shown in [Figure 1].
Figure 1: (a) Otoendoscopic view of the left tympanic membrane. (b) Outcome of myringotomy (grommet insertion) a normal tympanic membrane

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OME occurs commonly during childhood, with as many as 90% of children (80% of individual ears) having at least one episode of OME by age 10 years. OME disproportionately affects some subpopulations of children. Those with cleft palate, Down syndrome, and other craniofacial anomalies are at high risk for anatomic causes of OME and compromised the function of the  Eustachian tube More Details. Individuals of American Indian, Alaskan, and Asian backgrounds are believed to be at greater risk, as are children with adenoid hyperplasia. In addition, children with sensorineural hearing loss will likely be more affected by the secondary conductive hearing loss that occurs with OME. Although rare, OME also occurs in adults. This usually happens after patients develop a severe upper respiratory infection such as sinusitis, severe allergies, or rapid change in air pressure after an Aeroplane or a scuba dive. The incidence of prolonged OME in adults is not known, but it is much less common than in children. Many episodes of OME resolve spontaneously within 3 months, but 30–40% of children have recurrent episodes, and 5–10% of cases last more than 1 year. Despite the high prevalence of OME, its long-term impact on child developmental outcomes such as speech, language, intelligence, and hearing remains unclear. The near universality of this condition in children and the high expenditures for treating OME make this an important topic for a comparative effectiveness review. A variety of supplemental examination techniques assists with identification. Tympanometry is a supplemental diagnostic tool that indirectly measures middle ear pressure and tympanic membrane mobility. “Flat” tympanogram (Type B tympanogram) is consistent with OME. In addition, children with OME often have a conductive hearing loss on pure-tone audiometry that measures 25 decibels (dB) or 10 dB above the hearing level of children with normal hearing.

Pathophysiology

OME has several potential causes. The leading causes include viral upper respiratory infection, acute otitis media (AOM), and chronic dysfunction of the Eustachian tube; other potential explanations include ciliary dysfunction, proliferation of fluid-producing goblet cells, allergy and residual bacterial antigens and biofilm. More recent research suggests that mucoglycoproteins cause the hearing loss and much of the fluid presence that is the hallmark of OME. The presence of fluid in the middle ear decreases tympanic membrane and middle ear function, leading to decreased hearing, a “fullness” sensation in the ear, and occasionally pain from the pressure changes. In the majority of children, AOM is considered to have been triggered by a viral upper respiratory tract infection that damages the epithelium of the Eustachian tube, resulting in retention of middle ear fluid. There will be a full spectrum of fluid types made up of a mixture of the secretions of the epithelial cells, the goblet cells and the mucus glands along with the inflammatory exudate which comes through the intracellular spaces from the inflamed submucosa.

The main finding is that it is the mucins that come from the secretions that are responsible for the variable viscosity of the middle ear fluids. Once OME has become established, the normal, flat cuboidal middle ear and mastoid mucosa is patchily replaced by thickened pseudostratified mucus secreting epithelium with varying degrees of specialization, such as the development of cilia.


  Materials and Methods Top


A total of 56 patients of various age groups attending outpatient department of ENT, tertiary care center and Institute of Health Science from June 2013 to August 2015 who meet the inclusion criteria and give their written consent in local language will be included in the study. Impedance audiometry was used for confirmation of the diagnosis and Pure Tone Audiometry for the hearing measurement.

Criteria for inclusion

  1. Clinically diagnosed case of OME
  2. Audiometrically evaluated patient having conductive hearing loss (air-bone gap >15 dB)
  3. Tympanometry having 'B' Type curve.


Criteria for exclusion

  1. Patient on oral steroid therapy and any other medical intervention
  2. Patient having anomalies like cleft palate were excluded from this study.


Medical management includes topical intranasal steroids by mometasone furoate. The recommended dose for treatment of the nasal symptoms is 1 spray (50 μg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 μg) for the children 2–11 years of age. For adults and adolescents 12 years of age and older in which the recommended dose is 2 sprays (50 μg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 μg). Recommended duration of spray is 2–4 weeks and the stated achievement of the effect of spray is approximately 1–2 weeks.

Surgical management

It includes myringotomy with grommet insertion. In general, myringotomy is performed in conjunction with the insertion of a polyethylene tube called as grommet. Infants and small children are best managed by performing this procedure under a general anesthetic. In older children and adults, local anesthetic can be used as a single block in posterior canal wall so as it block Arnold's nerve. The radial incision in the tympanic membrane is usually made in the anteroinferior quadrant. There are many commercially available PE tubes. Depending on the design of the tube, it stays in the drum for few months to several years. The tube is extruded as the tympanic membrane heals. Counterbalancing this advantage of the T-tube is the heightened likelihood of permanent tympanic membrane perforation and cholesteatoma formation associated with the longer indwelling tube. In addition, like the short-term tubes, the long-term tubes can become obstructed with inspissated debris and require replacement. Consequently, long-term tubes are reserved for use in individuals with chronic Eustachian tube dysfunction.

Technique

Ear canal is cleaned of wax and debris. The field should be visualized under an operating microscope. A small radial or circumferential incision as shown in [Figure 2] is made in the anteroinferior quadrant of tympanic membrane. For insertion of Grommet (ventilation tube), incision should be just enough to admit the tube. Grommet inserted [Figure 3] and fluid drained out.
Figure 2: Circumferential incision

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Figure 3: Grommet in situ

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  Results Top


Selection of patients

Fifty-six patients were identified and included in the study. All the patients selected were visited to the department of otolaryngology and head neck surgery, in tertiary care hospital. For this study, selection of patients was done in continuation. Statistical analysis was done using descriptive and inferential statistics using Chi-square test and software used in the analysis were SPSS 17.0 version and Graph Pad Prism 5.0 version (GraphPad Software, Inc. Suite 230 La Jolla, CA 92037 USA) and P < 0.05 is considered as statistical significance.

Age and gender variation

In this study, out of 56 patients, 21 (age <14 years) were children and 35 (age >14 years) were adult patients. It showed no significant difference about the occurrence of disease. This means children and adult were affected equally. There were 11 (19.64%) male children, 10 (17.86%) female children and 17 (30.36%) adult male and 18 (32.14%) female. It was found that there was equal distribution gender wise, showing insignificant P = 0.078 which is >0.05.

Distribution of otitis media with effusion according to symptoms

On clinical examination fullness of ear was found equally in children and adult (28.57%), Otalgia was found in 66.67% of children and 45.71% adult patients and100% of patients both children and adult showed hearing impairment. About 9.52% of children and 40% of adult patients had a history of nasal allergy. History of nasal allergy most commonly was observed in adult patients and almost absent in childhood (P = 0.0001). Moreover, Otalgia (P = 0.002) which <0.05. Besides that complaint such as fullness in ear (P = 0.96) and hearing impairment P = 0.67, were not showed a significant difference in children and adult group.

Mean duration of disease

In our study, duration of the disease did not show much variation both in children as well as in adult, i.e., 5.72 weeks in male children and 7.11 weeks in male adult. Similarly, in female children, it was 8.40 weeks, and female adult showed 6.55 weeks of duration, and the outcome was almost same in children, i.e., 7 weeks as in adult 6.8 weeks.

Hearing loss

Hearing impairment due to underlying disease, i.e., OME was observed. The inference was drawn on the basis of who classification of impairment of hearing 2000. Out of 21 children, there were 7 (33.33%) children, and out of 35 adult 11 (31.43%) of adult had mild type of hearing loss, 11 (52.38%) children and 13 (37.14%) adult had moderate hearing loss. Moreover, 3 (14.29%) children and 11 (31.43%) adults had a severe conductive hearing loss. There is no study found before this which described hearing loss at different levels (no impairment, mild, moderate, severe, and profound).

Outcome of comparing myringotomy (grommet insertion) versus intranasal steroids

Hearing assessment done was compared among the group in which grommet was placed, and intranasal steroid was given both in children and adult. Similarly, failure rate and complications were also observed and studied separately. The comparison of grommet with intranasal steroids was done and results obtained. In grommet patients, 10 (47.62%) children and 17 (48.57%) adult were showed improvement as compared to steroid groups. Only 2 (9.52%) children and 10 (28.57%) adult patients showed improvement. Similarly, 1 (4.76%) child and 0 (0%) adult did not show improvement in grommet group as compare to steroids group more patients 8 (38.10%) children and 8 (22.86%) adult did not show improvement, comparison was also made about the difference in complication. In grommet group, 2 (9.52%) children and 2 (5.71%) adult showed complication whereas in steroids group 3 (14.29%) children 4 (11.43%) adults showed complications. There was more improvement, less complications, and less failure rate in patient treated with myringotomy with grommet insertion than in patients which received intranasal steroids. About 9.52% of children showed complication like extrusion of grommet before time; permanent perforation was observed in 5.71% adult patients after myringotomy and about 14.29% children and 11.43% adult patients showed nasal irritability due to prolonged use of nasal steroids sprays. P =0.0001 and is statistically significant, i.e., <0.05.


  Discussion Top


Fifty six patients were included in this study for medical and surgical intervention. All the patients were equally divided for myringotomy (ventilation tube insertion) and topical intranasal steroid treatment. Results were obtained on the basis of variations in age, sex, hearing loss, symptomatically variations, and improvement in surgical versus medical treatment.

Chang et al. conducted a study over differences between children and adults with OME treated with CO2 laser myringotomy in July 2011 in this study children (aged ≤14 years) and adults (aged ≥ 15 years) with OME of varying duration were included. CO2 laser myringotomy was indicated when conservative treatment, i.e., oral antibiotic therapy for more than 2 weeks, had failed.[1] Hemlin et al. 1997 reported 6-month data on OME resolution, but only provided these data for a subset of 15 (13%) patients who were considered cured at prior follow-up visits. No study assessed the effect of steroids on hearing or speech in the longer term. Given concern about treating what is often a self-limiting condition with systemic steroids, in this study, we were particularly interested to examine evidence for the effectiveness of topical intranasal steroids. No study documented hearing loss prospectively before study entry.[2] Seven studies included audiometry data in their outcomes, but hearing loss results of only three studies Macknin1985; Podoshin1990; Williamson 2002 these studies resulted that steroid treatment did not improve hearing loss and are only attempted to measure the effect of steroids on subjective symptoms.[3],[4],[5] Nuss and Berman 1990; Heary et al. 1990 included studies published in abstract form only and a non-randomized, open study. They concluded that combination therapy (oral steroids plus antibiotics) is worth considering in children with OME persisting beyond 8 weeks before surgical intervention.[6],[7] Rosenfeld and Post 1992 performed a meta-analysis of six randomized trials and concluded that children receiving oral steroids for seven to 14 days were three times more likely than control subjects to have both ears free of effusion at the end of therapy.[8] Berman 1994 and colleagues performed a meta-analysis of clinical effectiveness to establish cost-effectiveness of treatment for OME.[9] Tracy et al. 1998 stated Topical intranasal steroids may be safer than systemic preparations because the glucocorticoid is rapidly degraded in the nasal mucosa to less active metabolites and any unchanged drug that is absorbed is metabolized in the first pass through the liver.[10] Armstrong 1954 discuss the insertion of grommets (ventilation or tympanostomy tubes) into the eardrum is one of the most common operations in childhood. The primary indication for the operation is restoration of normal hearing with long-standing (more than three to 6 months) bilateral OME. The operation consists of an anterior, inferior myringotomy, with or without aspiration of the middle ear fluid and insertion of a small plastic or metallic ventilation tube or “grommet.” The rationale for the procedure is to improve ventilation and pressure regulation in the middle ear The procedure has been controversial for many years.[11] Mandel et al. 1987 in the three randomized trials, there was no evidence of a clinically important benefit to language development from screening and treating children with OME with grommets. Although there was a beneficial effect on the resolution of OME and improved hearing in the short-term (6 months), this effect largely disappeared in the long-term that is 12 months.[12] Butler et al. 2002 and Roberts et al. 2002 were undertaken a study to evaluate the effect of a new method of auto-inflation as an alternative treatment of secretory otitis media. Up to 80% of all children experience one or more episodes of Eustachian tube dysfunction and secretory otitis media before school age. Common treatment of this condition is the insertion of a ventilation tube in the tympanic membrane. Because of the very high incidence of secretory otitis media in childhood, insertion of ventilation tubes is the most frequently performed operation under general anesthesia in children. In addition to possible anesthetic complications, insertion of ventilation tubes may be associated with purulent suppuration, pathologic findings in the eardrum, and hearing impairment. One hundred children were consecutively randomized to undergo either auto-inflation, using a new device, or placed in a control group.[13],[14] Tos et al. were carried out a study of children between 3 and 10 years of age and were entered into the study after having had secretory otitis media for at least 3 months, as verified by tympanometric findings. Tympanometry was repeated at 2 weeks and at 1, 2, and 3 months after the children were entered into the study. After 2 weeks of auto-inflation, the tympanometric conditions were improved in 64% of ears, unchanged in 34%, and deteriorated in the remaining 2%. In the control group, tympanometric findings were improved in 15% of ears, unchanged in 71%, and deteriorated in the remaining 14%.[15] The point prevalence of otitis media with effusion in secondary school children in Pokhara Nepal after conducting study in school going children. This study aims to establish a reliable prevalence of OME in children between the ages of 9 and 16 years in order states that only age was found to be a significant predictor for developing OME; OME prevalence decreasing with increasing age. Results of this study are difficult to compare to existing literature due to the heterogeneity of age and diagnostic criteria in studies conducted. Caylan et al. conducted a study in Northeastern Turkey in children aged between 5 and 12 years and reported a prevalence of OME of 11.2%.[16] Apostolopoulos et al. reported the point prevalence of OME among school children in Greece aged between 6 and 12 years to be 6.5%, however, both type B and type C tympanogram traces were used to diagnose OME, so it is likely that this figure is an overestimate.[17] Rovers et al. 2000 stated that the very young children (under the age of 2 years) are more prone to problems with OME than older children.[18] Language learning under and over the age of 3 years is very different, and a stratification by age would have been appropriate. Included only children under the age of 2 years, and most of the children in the Pittsburgh study were under the age of 2 years, and all were randomized and treated before the age of 3 years by Paradise et al. 1999.[19] Raza et al. observed out of the 350 referred cases, pneumatic otoscopy by otolaryngologists diagnosed OME in 147 (42%, 95% confidence interval = 37.9–47.1). Out of these, 112 (76%) had retracted tympanic membrane, 25 (17%) had bulging of tympanic membrane, and 10/147 (6.08%) cases showed dullness of tympanic membrane with no additional features. Tympanometry confirmed fluid behind the tympanic membrane in 145/147 (98.6%) cases. Tuning fork tests showed negative Rinne's test in 122 (83%). Pure tone audiometry diagnosed deafness in 138/147 (93.8%) cases. The result shows OME with hearing loss is common in children having recurrent upper respiratory tract infection and nonspecific ear-related symptom.[20]


  Conclusion Top


  1. Topical nasal steroids are not as effective as myringotomy drainage of exudative material
  2. Placement of grommet for a long time gives proper drainage and clearance of disease
  3. Steroid use causes nasal irritation and temporary relief only
  4. Sometimes grommet retained in tympanic membrane needs manual removal
  5. Grommet seems to be more effective to cure disease
  6. Nonhealing perforation may result in some patients with grommet insertion
  7. Overall results are in the favor of myringotomy with grommet insertion.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Chang CW, Yang YW, Fu CY, Shiao AS. A Division of Otology, Department of Otorhinolaryngology-Head and Neck Surgery, Taipei Veterans General Hospital, Taipei, Taiwan, Division of Biostatistics, Institute of Public Health, National Yang Ming University, Taipei, Taiwan, National Yang-Ming University School of Medicine, Taipei, Taiwan. J Chin Med Assoc 2012;75:29-35.  Back to cited text no. 1
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2.
Hemlin C, Carenfelt C, Papatziamos G. Single dose of betamethasone in combined medical treatment of secretory otitis media. Ann Otol Rhinol Laryngol 1997;106:359-63.  Back to cited text no. 2
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Macknin ML, Jones PK. Oral dexamethasone for treatment of persistent middle ear effusion. Pediatrics 1985;75:329-35.  Back to cited text no. 3
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4.
Persico M, Podoshin L, Fradis M. Otitis media with effusion: A steroid and antibiotic therapeutic trial before surgery. Ann Otol Rhinol Laryngol 1978;87(2 Pt 1):191-6.  Back to cited text no. 4
    
5.
Williamson I. Otitis media with effusion. Clin Evid 2002;(8):511-8.  Back to cited text no. 5
    
6.
Nuss R, Berman S. Medical management of persistent middle ear effusion. Am J Asthma Allergy Pediatricians 1990;4:17-22.  Back to cited text no. 6
    
7.
Heary C, Hokanson J, Ury H, Chang C, Coplan B, Hall M. Lack of efficacy of short-term prednisone, trimethoprim sulfamethoxazole, alone or combined, in persistent otitis media with effusion: Season of entry as a possible determinant of outcome. Am J Dis Child 1990;144:420.  Back to cited text no. 7
    
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Rosenfeld RM, Post JC. Meta-analysis of antibiotics for the treatment of otitis media with effusion. Otolaryngol Head Neck Surg 1992;106:378-86.  Back to cited text no. 8
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9.
Stool SE, Berg AO, Berman S, Carney CJ, Cooley JR, Culepper L, et al. Otitis Media with Effusion in Young Children: Clinical Practice Guideline, Number 12. Rockville MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, Agency for Health Care Policy and Research Publication; 1994.  Back to cited text no. 9
    
10.
Tracy JM, Demain JG, Hoffman KM, Goetz DW. Intranasal beclomethasone as an adjunct to treatment of chronic middle ear effusion. Ann Allergy Asthma Immunol 1998;80:198-206.  Back to cited text no. 10
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Armstrong BW. A new treatment for chronic secretory otitis media. AMA Arch Otolaryngol 1954;59:653-4.  Back to cited text no. 11
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12.
Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. Results of a double-blind, randomized trial. N Engl J Med 1987;316:432-7.  Back to cited text no. 12
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Butler CC, Van Der Voort JH. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev 2002;(4):CD001935.  Back to cited text no. 13
    
14.
Roberts JE, Burchinal MR, Zeisel SA. Otitis media in early childhood in relation to children's school-age language and academic skills. Pediatrics 2002;110:696-706.  Back to cited text no. 14
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Tos M, Stangerup SE, Holm-Jensen S, Sørensen CH. Spontaneous course of secretory otitis and changes of the eardrum. Arch Otolaryngol 1984;110:281-9.  Back to cited text no. 15
    
16.
Caylan R, Bektas D, Atalay C, Korkmaz O. Prevalence and risk factors of otitis media with effusion in Trabzon, a city in Northeastern Turkey, with an emphasis on the recommendation of OME screening. Eur Arch Otorhinolaryngol 2006;263:404-8.  Back to cited text no. 16
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17.
Apostolopoulos K, Xenelis J, Tzagaroulakis A, Kandiloros D, Yiotakis J, Papafragou K. The point prevalence of otitis media with effusion among school children in Greece. Int J Pediatr Otorhinolaryngol 1998;44:207-14.  Back to cited text no. 17
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Rovers MM, Straatman H, Ingels K, van der Wilt GJ, van den Broek P, Zielhuis GA. The effect of ventilation tubes on language development in infants with otitis media with effusion: A randomized trial. Pediatrics 2000;106:E42.  Back to cited text no. 18
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19.
Paradise JL, Bluestone CD, Colborn DK, Bernard BS, Smith CG, Rockette HE, et al. Adenoidectomy and adenotonsillectomy for recurrent acute otitis media: Parallel randomized clinical trials in children not previously treated with tympanostomy tubes. JAMA 1999;282:945-53.  Back to cited text no. 19
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Raza M, Jalil J, Shafique M, Ghafoor T. Frequency of Otitis Media with Effusion in Recurrent Upper Respiratory Tract Infection in Children. Combined Military Hospital, Gujranwala. Journal of the College of Physicians and Surgeons--Pakistan 2008;18:226-9.  Back to cited text no. 20
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