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.

Details

Title
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
van Uum, Rick T. 1   VIAFID ORCID Logo  ; Venekamp, Roderick P. 1 ; Sjoukes, Alies 1 ; van de Pol, Alma C. 1 ; de Wit, G. Ardine 2 ; Schilder, Anne G. M. 3 ; Damoiseaux, Roger A. M. J. 4 

1  Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands 
2  Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; National Institute of Public Health and the Environment, Centre for Nutrition, Prevention and Healthcare, Bilthoven, The Netherlands (GRID:grid.31147.30) (ISNI:0000 0001 2208 0118) 
3  Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands (GRID:grid.31147.30); evidENT, Ear Institute, University College London, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201) 
4  Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands (GRID:grid.83440.3b) 
Pages
501
Publication year
2018
Publication date
Dec 2018
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-018-2880-4
ProQuest document ID
2795309850
Copyright
© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.