Acute otitis media in children Ear, Nose and Throat Acute otitis media in children
Conditions
Interventions
Randomsed controlled trial:
Eligible, consented children will be randomised in a ratio of 1:1:1 to receive either:
1. Usual care: patients will receive the current best
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Randomised Controlled Trial: 1. Children presenting within 72 hours of suspected AOM onset (other preceding respiratory tract infection symptoms may be longer) 2. Legal guardian (hereon parent) available to give immediate verbal (telephone) and written (within 24 hours) consent 3. Parent-reported ear pain in 24 hours pre-enrolment (unless child too young to report pain, when GP-ascertained otoscopic evidence alone sufficient) 4. GP-ascertained otoscopic evidence of acute inflammation (operationalised as per our previous trial6 as: dullness or cloudiness with erythema; or bulging) 5. Clinician willing to use a NICE recommended no or delayed antibiotic strategy 6. Parent able to give ear drops 7. Parent willing to able to complete symptom diary 8. Parent willing and available to receive follow-up telephone calls within first three days and at one week post recruitment Children with cystic fibrosis (CF) and severe learning difficulties will be included, to maintain generalizability. We are not aware of evidence that AOM is different in children with CF, and the treating clinician will be responsible for deciding if children are safe to receive delayed antibiotics. Parents will be able to complete pain scores for children with severe learning difficulties. Observational Cohort Study: 1. Children presenting within 72 hours of suspected AOM onset (other preceding respiratory tract infection symptoms may be longer) 2. Legal guardian (hereon parent) available to give immediate verbal (telephone) and written (within 24 hours) consent 3. Parent-reported ear pain in 24 hours pre-enrolment (unless child too young to report pain, when GP-ascertained otoscopic evidence alone sufficient) 4. GP-ascertained otoscopic evidence of acute inflammation (operationalised as per our previous trial) as: dullness or cloudiness with erythema; or bulging) 5. Parent willing to able to complete symptom diary 6. Parent willing and available to receive follow-up telephone calls within first three days and at one week post recruitment
Exclusion criteria
Exclusion criteria: Randomised Controlled Trial: 1. Requirement for immediate oral antibiotic for AOM (e.g. NICE recommend for children under 2 years with bilateral AOM or otorrhoea) or another infection 2. Alternative source of pain 3. GP-ascertained otoscopic appearances consistent with fever or crying (pink drum alone) 4. Diagnosis more suggestive of otitis media with effusion (glue ear) 5. Suspected or confirmed perforation (theoretical but unconfirmed risk of ototoxicity from active drops, seen in 7% of children with AOM5) 6. Known sensitivity to study medicine; child requiring immediate hospitalisation Observational Cohort Study: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any antibiotic consumed by day 7 (measured using symptom diary and telephone call at 1 week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcome: Ear pain over first 24 hours using the parent completed, validated numerical rating scale successfully used in our previous trials (symptom diary and telephone call in first three days) and child completed Faces Pain Scale Revised (FPS-R)14 for children aged 5 years) 6. NHS costs up to 7 days (symptom diary) and contacts to 3 months (primary care medical notes review) 7. Child's school/nursery absences, parent lost productivity and other expenses up to 7 days (symptom diary) 8. Child's quality of life (OMQ-14,19 modified for <3 years) at baseline and 3 months (postal questionnaire) 9. Qualitative outcomes to assess acceptability, barriers and adherence, a purposeful sample of parents and clinicians will be asked to participate in qualitative interviews to explore experiences of, and attitudes to AOM and its treatment | — |
Countries
United Kingdom
Outcome results
None listed