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Trials. 2018 Sep 17;19(1):501. doi: 10.1186/s13063-018-2880-4.

Optimising pain management in children with acute otitis media through a primary care-based multifaceted educational intervention: study protocol for a cluster randomised controlled trial.

Author information

1
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Stratenum 5.143, PO Box 85500, 3508, GA, Utrecht, The Netherlands. r.t.vanuum-2@umcutrecht.nl.
2
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Stratenum 5.143, PO Box 85500, 3508, GA, Utrecht, The Netherlands.
3
Centre for Nutrition, Prevention and Healthcare, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.
4
evidENT, Ear Institute, University College London, London, UK.

Abstract

BACKGROUND:

Whilst current guidelines highlight the importance of pain management for children with acute otitis media (AOM), there is evidence to suggest that this is not implemented in everyday practice. We have developed a primary care-based multifaceted educational intervention to optimise pain management in children with AOM, and we trial its clinical and cost effectiveness.

METHODS:

This cluster randomised controlled trial aims to recruit 250 children aged 6 months to 10 years presenting with AOM to general practitioners (GPs) in 30 primary care centres (PCCs) across the Netherlands. GPs in the PCCs allocated to the intervention group receive a blended GP educational programme (online and face-to-face training). The intervention asks GPs to proactively discuss pain management with parents using an information leaflet, and to prescribe paracetamol and ibuprofen according to current guidelines. GPs in both groups complete an online module illustrating various otoscopic images to standardise AOM diagnosis. GPs in the PCCs allocated to the control group do not receive any further training and provide 'care as usual'. During the 4-week follow-up, parents complete a symptom diary. The primary outcome is the difference in parent-reported mean earache scores over the first 3 days. Secondary outcomes include both number of days with earache and fever, GP re-consultations for AOM, antibiotic prescriptions, and costs. Analysis will be by intention-to-treat.

DISCUSSION:

The optimal use of analgesics through the multifaceted intervention may provide symptom relief and thereby reduce re-consultations and antibiotic prescriptions in children with AOM.

TRIAL REGISTRATION:

Netherlands Trial Register, NTR4920 . Registered on 19 December 2014.

KEYWORDS:

Acute otitis media; Analgesics; Multifaceted intervention; Pain management; Primary care; RCT

PMID:
30223903
PMCID:
PMC6142388
DOI:
10.1186/s13063-018-2880-4
[Indexed for MEDLINE]
Free PMC Article

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