Persistent Bilateral Otitis Media Research Articles

A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion

PurposeTo study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2–12 years with adenoidal hypertrophy and its impact on change in quality of life. MethodA prospective randomized double blind interventional placebo control study was conducted. Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2–12 years were enrolled in this study. Among these sixty two patients had persistent bilateral otitis media with effusion more than three months. These were randomly divided into two groups, group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period. Patients were evaluated with symptom, pure tone audiometry wherever possible, pneumatic otoscopic examination and tympanogram at 0, 8 and 24weeks. ResultsResolution of otitis media with effusion in study group (28 out of 30) was significantly higher as compared control group (16 out of 32) (p value 0.0004). A significant improvement in hearing and symptoms was seen in the study group (p<0.04). Statistically significant change in quality of life was seen with mometasone nasal spray (37.11) as compared to saline nasal spray (11.02) (p value 0.0001). ConclusionMometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy.

Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial

To determine the adjuvant effects of adenoidectomy with short-stay ventilation tubes to hearing and revision surgery in children over 3.5 years with persistent otitis media with effusion. Randomised controlled three armed trial: observation, short-stay ventilation tube or ventilation tubes with adjuvant adenoidectomy. Five follow-up visits over 2 years. Eleven UK Otorhinolaryngology Departments. Children with bilateral otitis media with effusion and better ear hearing level (HL) ≥20 dB persistent for 3 months. Of the 425 eligible children, 376 (88%) accepted randomisation. Pure-tone hearing thresholds, eligibility for and actual revision surgery rates, otoscopic sequelae and complications of adenoidectomy. Loss to follow-up at 3, 12 and 24 months was 2%, 6% and 5% respectively. Of the 376 randomised children, 253 (67%) had complete data for all five follow-up visits. Adenoidectomy did not add to the benefit to hearing thresholds of ventilation tubes of 8.8 dB (CI: 7.1-10.5) averaged over 3-6 months postoperatively. Averaged over 12, 18 and 24 months, adenoidectomy provided 4.2 dB of benefit (CI: 2.6-5.7) whilst ventilation tubes gave no benefit. Standardised effect sizes through two years showed equal benefit from ventilation tubes (0.50 sd) and adenoidectomy (0.61 sd) which are additive (1.11 sd). Adenoidectomy halved the numbers meeting a 25 dB HL bilateral cut-off for eligibility for repeat tube surgery from 31% to 14% at 12 months and from 33% to 15% at 18 months. The actual reduction in re-insertion surgery (absolute risk difference) was 21%. In tubed ears, tympanosclerosis occurred in 27%, but otorrhoea in only <2% and permanent perforations in <1%. These events did not occur in control ears. In children that had adenoidectomy, one of 165 (0.6%) had haemorrhage that required return to theatre. Adjuvant adenoidectomy doubles benefit from short-stay ventilation tubes by extending better hearing through the second year in children aged 3.25-6.75 years with persistent otitis media with effusion with at least a 20 dB HL in both ears. The duration of benefit of adenoidectomy is related to the duration of function of the type of the ventilation tubes used. Adenoidectomy also substantially reduces eligibility for revision surgery.

Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial

Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial

Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial

Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial

Topical intranasal corticosteroids in 4‐11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial

Clinical OtolaryngologyVolume 35, Issue 2 p. 125-133 Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial First published: 11 April 2010 https://doi.org/10.1111/j.1749-4486.2009.02090.xCitations: 2Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Citing Literature Volume35, Issue2April 2010Pages 125-133 RelatedInformation

A double-blind randomised placebo-controlled trial of topical intranasal corticosteroids in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care

To determine the clinical effectiveness and cost-effectiveness of topical mometasone in children with bilateral otitis media with effusion (OME). A double-blind randomised placebo-controlled trial with an intention to treat analysis; the 10.6% of patients lost to follow-up at 1 month were censored in the analysis. 76 Medical Research Council General Practice Research Framework practices throughout the UK between 2004 and 2007. A sample of 217 children aged 4-11 years was selected from those presenting to their GP with one or more episodes of otitis media or ear-related problems in the previous 12 months whom the research nurse confirmed had bilateral glue ear using microtympanometry (B B or B C2 types using a modified Jerger classification) at randomisation. Mometasone 50 micrograms in each nostril or placebo spray once daily for 3 months. The primary outcome was the proportions of children cleared of OME assessed by tympanometry at 1 month. Secondary outcomes included clearance at 3 months and 9 months; adverse events; OM8-30 scores (a functional health status responsive disease-specific measure); hearing loss; days with otalgia; cost-effectiveness; and health utilities. Of the topical steroid group, 40.6% (39/96) demonstrated tympanometric clearance (C1 or A type) in one or both ears at 1 month, compared with 44.9% (44/98) of the placebo group. The absolute risk reduction at 1 month was -4.3% (95% CI -18.05% to 9.26%); the odds ratio (OR) was 0.84 (95% CI 0.48 to 1.48). Four covariates were pre-specified for inclusion in logistic regression analysis: age as a continuous variable (p = 0.94), season (p = 0.70), atopy (p = 0.61) and clinical severity (p = 0.006). The adjusted OR (AOR) at 1 month for the main outcome was 0.93 (95% CI 0.50 to 1.75). Secondary analysis at 3 months showed 58.1% of the steroid group had resolved and 52.3% of the placebo group, AOR 1.45 (95% CI 0.74 to 2.84). At 9 months 55.6% of the treated group remained clear in at least one ear and 65.3% of the placebo group, AOR 0.82 (95% CI 0.39 to 1.75). Adverse events (although relatively minor) occurred in 7-22% of children and included nasal stinging, epistaxis, dry throat and cough. The OM8-30 scores (p = 0.55) reported hearing difficulty (p = 0.08), and days with otalgia (p = 0.46) were not significantly different between groups at 3 months. The economic evaluation found the active treatment arm to be dominated by placebo, accruing slightly (but not significantly) higher costs and fewer quality-adjusted life-years (QALYs), with a 24.2% probability that topical steroids are a cost-effective use of NHS resources at a ceiling ratio of 20,000 pounds per QALY gained. Use of topical intranasal corticosteroids is very unlikely to be a clinically effective treatment for OME (glue ear) in the primary care setting. Current Controlled Trials ISRCTN38988331.

Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial

Objective To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion.Design Double blind randomised placebo controlled trial.Setting 76 Medical Research Council General Practice...

Use of Adenoidectomy and Adenotonsillectomy in Children with Otitis Media with Effusion

We conducted a prospective study of 48 children, aged 2 to 14 years, who had persistent bilateral otitis media with effusion, enlarged adenoids, and a bilateral conductive hearing loss. Half of these patients underwent adenoidectomy and the other half adenotonsillectomy. All patients were followed every 2 weeks for up to 6 months. At 2 months postoperatively, the overall success rate in terms of the resolution of middle ear effusion was 85.1%. Success rates were 82.6% in the adenoidectomy group and 87.5% in the adenotonsillectomy group; the difference was not statistically significant. Our findings demonstrate that both adenoidectomy and adenotonsillectomy are effective for the treatment of persistent otitis media with effusion, and they confirm the findings of other studies. Based on our findings and those of other investigators, we offer a four-step approach to the management of these children.

Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting

The objective was to study the generalizability of trial results by comparing randomized patients to eligible but nonrandomized patients who received the same management. Implementation of trial results is only justifiable when the results can be generalized to the total domain population. The design was a multicentre randomized controlled trial on the effect of early screening and treatment with ventilation tubes on infants with otitis media with effusion. Randomized ( n = 187) and nonrandomized eligible patients ( n = 133) were followed up. The study population comprised children who were detected by auditory screening at the age of 9–12 months and who were subsequently diagnosed with persistent bilateral otitis media with effusion for 4–6 months. A significant difference was found in the distribution of some prognostic factors: more randomized children had older siblings, did not attend day care and had mothers with a lower educational level than the nonrandomized children. These factors, however, did not modify the outcome. No differences were found in mean hearing levels between the randomized and nonrandomized children: in both the randomized and nonrandomized children ventilation tubes improved the hearing level, especially after 6 months. However, in the long term (12 months), the hearing levels were equal again. The results of the randomized and nonrandomized patients were comparable. The results of this trial appear to be generalizable to the total domain population. The procedure of following up both randomized and nonrandomized patients is recommended when there is concern about selective participation and reduced generalizability.

Tympanic membrane atrophy, scarring, atelectasis and attic retraction in persistent, untreated otitis media with effusion and following ventilation tube insertion

Two hundred and twenty two children with persistent bilateral otitis media with effusion (OME) were treated with unilateral ventilation tube insertion and no treatment to the contralateral ear. The tympanic membrane changes in the operated and unoperated ears were compared during a 12 year follow-up. Segmental atrophy resulted from tube insertion whereas minor scarring and thickening of the pars tensa was related to the middle ear condition. Eighty three percent of untreated ears and 85% of those treated with tubes did not develop atelectasis. Sixty percent of untreated ears and 64% of treated ears did not develop attic retraction. Very few cases (1.5 and 2%) in untreated and treated ears, respectively developed severe atelectasis. The overall duration of OME was assessed from the pre-operative history of hearing loss, the 3 month period of pre-operative observation and the post-operative time with effusion. There is a relationship between duration of the disease and development of both atelectasis and attic retraction.

The effect of treatment with ventilating tubes on language development in preschool children with otitis media with effusion

The effect of bilateral tube insertion on language development was studied in a randomized controlled trial of 43 preschool children with persistent bilateral otitis media with effusion (OME). Improvement in language scores was observed in both the treatment and non-treatment groups. There was a minor difference in favour of the treatment group which did not reach statistical significance. Although there is a growing consensus that otitis media with effusion can have negative effects on language development in young children, it has not yet been proved that this effect can be reversed by treatment with ventilating tubes.