Ear discharge in children presenting with acute otitis media: observational study from UK general practice

Smith, Lindsay; Ewings, Paul; Smith, Caroline; Thompson, Matthew; Harnden, Anthony; Mant, David

doi:10.3399/bjgp10x483148

“…Kalm et al 1991 [8] mentioned that genetic factors may play a role in susceptibility to OM, HLA-A2 gene has been noted to be with R AOM, but not OME. RAOM was found in 3.5% of the patients group in our study and was noted to be associated significantly with ear discharge (p = 0.000) and significantly negatively correlated with ear pain (p = 0.000); this observation could be explained by what is mentioned by Smith et al 2010 [9], that ear discharge may define a group of children who have severe disease and more adverse outcome. Ear pain in our patient's group was expressed by parent's words in the form of ear tugging and excessive crying in 65% of cases, but interpretation of these symptoms may be influenced by the socioeconomic status [10], so ear pain and ear discharge which were the most significant symptoms of our group of patients, were not significantly correlated with otoscopic diagnosis of OM.…”

Section: Discussionsupporting

confidence: 67%

Assessment of Infants and Children with Symptoms Suggesting Otitis Media

Nasr¹,

Esayd²,

Abdelaal³

2014

OALib

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Symptoms suggesting occurrence of otitis media (OM) in infants and young children are not always right. Objective: Assessment of those infants and children with symptoms suggesting otitis media. Patients & Methods: 113 infants and children were complaining of ear symptoms suggesting otitis media as well as 63 infants and children of same age and sex were not complaining of any of these symptoms suggesting otitis media, were fully investigated prospectively, by full clinical and ear, nose examination as well as swab culture from the ear discharge. Results: There was no statistical significant difference between the prevalence of otitis related symptoms and the risk factors in both groups. There was no correlation found between the otoscopic diagnosis of OM and the main complaint suggesting OM in the patients, mainly ear pain and ear discharge. There was a positive significant correlation between otoscopic diagnosis of OM and fever, diarrhea, and bronchiolitis (significance was at 0.01, 0.01 and 0.05 levels respectively). Conclusion: Otoscopic examination is very important in any infant or child complaining of ear pain, ear discharge or complaining of otitis related symptoms.

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“…is active against all common otopathogens 3 ; is non-ototoxic; is widely and routinely available in the UK; is colourless so will not interfere with assessing otorrhoea;will provide complementary evidence to the ZonMw funded trial, which is using an antibiotic-steroid combination.…”

Section: Choice Of Comparatormentioning

confidence: 99%

“…problems at 3 months 3 . Estimates of parental costs (travel, over the counter (OTC) medicines and lost earnings) vary [5][6][7] , with even the lowest suggesting £4M in England and Wales per annum.…”

mentioning

confidence: 97%

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.

Curtis

¹

,

Taylor

²

,

Moore

³

et al. 2020

Preprint

0

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Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd.Methods: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months. Discussion: It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition. Trial registration:Name of Registry: ISCRTNRegistration Number: ISRCTN12873692 This contains all items required to comply with the World Health Organization Trial Registration Data SetDate of Registration: 24th April 2018 http://www.isrctn.com/ISRCTN12873692Name of Registry: EudraCT Registration Number: 2017-003635-10Date of Registration: 6TH September 2017

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“…In around 15% of cases, a rise in middle-ear pressure and/or inflammation weakening the tympanic membrane results in it bursting, discharging pus from the middle ear as a discharge (otorrhoea) [1]. Children with AOM and discharge (AOMd) have similar levels of pain and are more unwell at presentation than children with AOM [2,3]. Moreover, children with AOMd have a worse prognosis, and higher rates of pain at 1 week, as reported by parents (carers), repeat AOM episodes and hearing problems at 3 months [2].…”

mentioning

confidence: 99%

“…Children with AOM and discharge (AOMd) have similar levels of pain and are more unwell at presentation than children with AOM [2,3]. Moreover, children with AOMd have a worse prognosis, and higher rates of pain at 1 week, as reported by parents (carers), repeat AOM episodes and hearing problems at 3 months [2]. Estimates of parental costs (travel, over the counter (OTC) medicines and lost earnings) vary [4][5][6], with even the lowest suggesting £4 million in England and Wales per annum.…”

mentioning

confidence: 99%

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol

Curtis

¹

,

Moore

²

,

Cabral

³

et al. 2020

Trials

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Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd. Methods/design: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it

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Ear discharge in children presenting with acute otitis media: observational study from UK general practice

Abstract: BackgroundNational Institute for Health and Clinical Excellence (NICE) guidance to treat otitis media in older children immediately with antibiotics only if they have ear discharge is based on limited evidence.

Cited by 24 publications

References 20 publications

Assessment of Infants and Children with Symptoms Suggesting Otitis Media

Assessment of Infants and Children with Symptoms Suggesting Otitis Media

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.

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