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, 19 (1), 501

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


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

Rick T van Uum et al. Trials.


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.

Conflict of interest statement

Ethics approval and consent to participate

The trial is conducted according to the principles of the Declaration of Helsinki (10th version, October 2013) [52] and the Dutch Conduct Code Health Research (Gedragscode Gezondheidsonderzoek “Goed Gedrag”) [53]. The Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands, reviewed the study protocol (protocol WAG/om/14/021633) and confirmed that an official approval was not required since the Medical Research Involving Human Subjects Act (WMO) does not apply to our trial since participation in the study does not add to the risks inherent to the condition (AOM) and its management in Dutch primary care.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.


Fig. 1
Fig. 1
Overview and schedule of enrolment, data collection, and assessments (SPIRIT Figure). 1Baseline data includes age, gender, medical history, day-care attendance, vaccination status, exposure to tobacco smoke, family composition, and items discussed by general practitioner (GP) during acute otitis media (AOM) consultation. 2Symptoms include earache (on Wong-Baker Faces Scale rating), ear discharge, fever, runny nose, cough, disturbed sleep, diarrhoea, obstipation, vomiting, decreased fluid intake, abdominal pain, and rash. 3Medication use includes specification of type of medication, dosing frequency, actual dosage given, over-the-counter medication, (delayed) antibiotic prescription. 4Productivity loss is captured as composite of number of days absence from work (parent) or day-care (child), number of hours a nanny was required, and costs of nanny employment. 5Adverse events include gastrointestinal complaints, as well as serious adverse events such as renal failure, gastrointestinal bleeding, and hypersensitivity reactions. 6GP re-consultation includes out-of-hours consultation and referral to secondary care (i.e. emergency room visits, hospital admissions, and surgical procedures). PCC primary care centre

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    1. Damoiseaux RAMJ, Venekamp RP, Eekhof JAH, Bennebroek Gravenhorst FM, Schoch AG, Wittenberg J, et al. NHG-standaard Otitis media acuta bij kinderen. Huisarts Wet. 2014;57(12):648.
    1. Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Tunkel DE, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013;131(3):e964–e999. doi: 10.1542/peds.2012-3488. - DOI - PubMed
    1. Coco A, Vernacchio L, Horst M, Anderson A. Management of acute otitis media after publication of the 2004 AAP and AAFP clinical practice guideline. Pediatrics. 2010;125(2):214–220. doi: 10.1542/peds.2009-1115. - DOI - PubMed
    1. Forrest CB, Fiks AG, Bailey LC, Localio R, Grundmeier RW, Alessandrini AE. Improving adherence to otitis media guidelines with clinical decision support and physician feedback. Pediatrics. 2013;131:e1071–e1081. doi: 10.1542/peds.2012-1988. - DOI - PubMed
    1. Pulkki J, Huikko S, Rautakorpi U-M, Honkanen P, Klaukka T, Mäkelä M, et al. Management of pain in acute otitis media in Finnish primary care. Scand J Infect Dis. 2006;38(4):265–267. doi: 10.1080/00365540500434679. - DOI - PubMed

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