Acute otitis media, Children, Ear pain, Analgesics, General Practice
Conditions
Interventions
Participating general practices will be randomised to either the intervention arm or to the ’usual care’ arm.
Intervention: A primary-care based multifaceted intervention: 1) a blended learning targe
2) an interactive parent information leaflet
and 3) a prescription of paracetamol and ibuprofen to be filled by parents the same day. In the blended learning GPs will be trained to a) address pain management during consultation by using effectiv
b) adhere to the 2014 guideline “AOM in children” and the 2007 “Pain Relief’ guideline issued by the Dutch College of General Practitioners which recommend a high dose paracetamol at fixed time interv
c) use an interactive leaflet during consultation
and d) prescribe paracetamol and ibuprofen (as add-on if needed).
Control: In the control group, the GPs will provide ‘care as usual’.
Antibiotics will be prescribed according to the discretion of
Sponsors
University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 6 months to 10 years presenting to their GP with ear pain resulting in a GP diagnosis of AOM according to the diagnostic criteria of the practice guideline “AOM in children” issued by the Dutch College of General Practitioners.
Exclusion criteria
Exclusion criteria: • Ventilation tubes in place • Down’s syndrome • Craniofacial malformation such as cleft palate • Known immunodeficiencies • Renal failure/insufficiency • Children that were previously included in the trial • A sibling that was previously included in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean ear pain score during the first 3 days after the initial visit to the GP as measured by the Wong-Baker FACES® Pain Rating Scale (WBS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days with ear pain and ear pain severity; 2. Number of days with fever; 3. Proportion of children with ear pain at various time points (24 hours, 2 to 3 days, 4 to 7 days); 4. GP reconsultations because of AOM; 5. (Delayed) antibiotic prescriptions because of AOM; 6. Health-related quality of life (HRQoL) of the child and its parents; 7. Parental days off work, days lost from nursery or school for children; 8. Complications of AOM, including acute mastoiditis, meningitis and intracranial abscess; 9. Adverse effects of analgesics; 10. Costs (cost-effectiveness). | — |
Contacts
Public ContactRick van Uum
UMC Utrecht
Outcome results
None listed