scholarly journals Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Respati W. Ranakusuma ◽  
Amanda R. McCullough ◽  
Eka D. Safitri ◽  
Yupitri Pitoyo ◽  
Widyaningsih Widyaningsih ◽  
...  
Keyword(s):  
Pilot Study ◽  
Sample Size ◽  
Otitis Media ◽  
Middle Ear ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Controlled Study ◽  
Antibiotic Prescribing ◽  
Open Label ◽  
Oral Corticosteroids

Abstract Background Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM. Methods We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months–12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing middle ear inflammation by reducing MEE. Results We screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference − 7.4 mm, 95% confidence interval (CI) − 13.4 to − 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study. Conclusions It is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this. Trial registration Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

scholarly journals Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amanda Jane Leach ◽  
Edward Kim Mulholland ◽  
Mathuram Santosham ◽  
Paul John Torzillo ◽  
Peter McIntyre ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Otitis Media ◽  
Conjugate Vaccine ◽  
Otitis Media With Effusion ◽  
Controlled Trial ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Open Label ◽  
Suppurative Otitis Media ◽  
Link Type

Abstract Background Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months. Methods In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2–4-6 months (_PPP), Synflorix™ (S) at 2–4-6 months (_SSS), or Synflorix™ at 1–2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM). Results Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM. Conclusions Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life. Trial registration ACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.govNCT01174849 registered 04/08/2010.

scholarly journals Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study)

2018 ◽  
Vol 4 (1) ◽  
Author(s):  
Respati W. Ranakusuma ◽  
Amanda R. McCullough ◽  
Eka D. Safitri ◽  
Yupitri Pitoyo ◽  
Widyaningsih ◽  
...  
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Oral Prednisolone ◽  
Controlled Study ◽  
Open Label

Myringotomy in acute otitis media. A controlled study

JAMA ◽  
1966 ◽  
Vol 197 (11) ◽  
pp. 849-853 ◽  
Author(s):  
O. F. Roddey
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Controlled Study

Acute otitis media increases middle ear susceptibility to nasal injection of

1994 ◽  
Vol 110 (1) ◽  
pp. 115-121 ◽  
Author(s):  
P ANTONELLI ◽  
S JUHN ◽  
C LE ◽  
G GIEBINK
Keyword(s):  
Otitis Media ◽  
Middle Ear ◽  
Acute Otitis Media

scholarly journals Adenoidectomy for middle ear disease in cleft palate children: a systematic review

2021 ◽  
Author(s):  
Cecilia Rosso ◽  
Antonio Mario Bulfamante ◽  
Carlotta Pipolo ◽  
Emanuela Fuccillo ◽  
Alberto Maccari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cleft Palate ◽  
Otitis Media ◽  
Middle Ear ◽  
Acute Otitis Media ◽  
Case Series ◽  
Velopharyngeal Insufficiency ◽  
Middle Ear Disease ◽  
Conductive Hearing

Abstract Purpose Cleft palate children have a higher incidence of otitis media with effusion, more frequent recurrent acute otitis media episodes, and worse conductive hearing losses than non-cleft children. Nevertheless, data on adenoidectomy for middle ear disease in this patient group are scarce, since many feared worsening of velopharyngeal insufficiency after the procedure. This review aims at collecting the available evidence on this subject, to frame possible further areas of research and interventions. Methods A PRISMA-compliant systematic review was performed. Multiple databases were searched with criteria designed to include all studies focusing on the role of adenoidectomy in treating middle ear disease in cleft palate children. After duplicate removal, abstract and full-text selection, and quality assessment, we reviewed eligible articles for clinical indications and outcomes. Results Among 321 unique citations, 3 studies published between 1964 and 1972 (2 case series and a retrospective cohort study) were deemed eligible, with 136 treated patients. The outcomes were positive in all three articles in terms of conductive hearing loss improvement, recurrent otitis media episodes reduction, and effusive otitis media resolution. Conclusion Despite promising results, research on adenoidectomy in treating middle ear disease in the cleft population has stopped in the mid-Seventies. No data are, therefore, available on the role of modern conservative adenoidectomy techniques (endoscopic and/or partial) in this context. Prospective studies are required to define the role of adenoidectomy in cleft children, most interestingly in specific subgroups such as patients requiring re-tympanostomy, given their known risk of otologic sequelae.

scholarly journals 23. Regional Variation in Outpatient Antibiotic Prescribing in a Commercially-insured Population, United States, 2017

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S12-S12
Author(s):  
Destani J Bizune ◽  
Danielle Palms ◽  
Laura M King ◽  
Monina Bartoces ◽  
Ruth Link-Gelles ◽  
...  
Keyword(s):  
United States ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Urgent Care ◽  
Antibiotic Prescribing ◽  
Tier 2 ◽  
Regional Variability ◽  
Patient Age ◽  
Patient Âgé ◽  
Tier 3

Abstract Background Studies have shown that the Southern United States has higher rates of outpatient antibiotic prescribing compared to other regions in the country, but reasons for this variation are unclear. We aimed to determine whether the regional variability in outpatient antibiotic prescribing for respiratory diagnoses can be explained by differences in patient age, care setting, comorbidities, and diagnosis in a commercially-insured population. Methods We analyzed the 2017 IBM® MarketScan® Commercial Database of commercially-insured individuals aged < 65 years. We included visits with acute respiratory tract infection (ARTI) diagnoses from retail clinics, urgent care centers, emergency departments, and physician offices. ARTI diagnoses were categorized as: Tier 1, antibiotics are almost always indicated (pneumonia); Tier 2, antibiotics are sometimes indicated (sinusitis, acute otitis media, pharyngitis); and Tier 3, antibiotics are not indicated (asthma, allergy, bronchitis, bronchiolitis, influenza, nonsuppurative otitis media, viral upper respiratory infections, viral pneumonia). We calculated risk ratios and 95% confidence intervals (CI) stratified by US Census region and ARTI tier using log-binomial models controlling for patient age, comorbidities (Elixhauser and Complex Chronic Conditions for Children), and setting of care, with Tier 3 visits in the West, the strata with the lowest antibiotic prescription rate, as the reference for all strata. Results A total of 100,104,860 visits were analyzed. In multivariable modeling, ARTI visits in the South and Midwest were highly associated with receiving an antibiotic for Tier 2 conditions vs. patients in other regions (Figure 1). Figure 1. Multivariable model comparing risk of receiving an antibiotic for an ARTI by region and diagnostic tier in urgent care, retail health, emergency department, and office visits, MarketScan® 2017, United States Conclusion Regional variability in outpatient antibiotic prescribing for Tier 2 and 3 ARTIs remained even after controlling for patient age, comorbidities, and setting of care. It is likely that this variability is in part due to non-clinical factors such as regional differences in clinicians’ prescribing habits and patient expectations. Targeted and enhanced public health stewardship interventions are needed to address cultural factors that affect antibiotic prescribing in outpatient settings. Disclosures All Authors: No reported disclosures

An Open-Label, Double Tympanocentesis Study of Levofloxacin Therapy in Children With, or at High Risk for, Recurrent or Persistent Acute Otitis Media

2006 ◽  
Vol 25 (12) ◽  
pp. 1102-1109 ◽  
Author(s):  
Adriano Arguedas ◽  
Ron Dagan ◽  
Michael Pichichero ◽  
Eugene Leibovitz ◽  
Jeffery Blumer ◽  
...  
Keyword(s):  
High Risk ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Open Label

Aerobic and Anaerobic Bacteria in the Middle ear and ear Canal in Acute Otitis Media

1982 ◽  
Vol 93 (sup386) ◽  
pp. 100-102 ◽  
Author(s):  
J. Luotonen ◽  
A. M. M. Jokipii ◽  
P. Sipilä ◽  
J. Väyrynen ◽  
L. Jokipii ◽  
...  
Keyword(s):  
Otitis Media ◽  
Middle Ear ◽  
Anaerobic Bacteria ◽  
Acute Otitis Media ◽  
Ear Canal ◽  
Aerobic And Anaerobic
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