Abstract

BackgroundPain management in acute otitis media (AOM) is often suboptimal, potentially leading to unnecessary discomfort, GP reconsultation, and antibiotic prescribing.AimTo assess the effectiveness of a GP-targeted educational intervention to improve pain management in children with AOM.Design and settingPragmatic, cluster randomised controlled trial (RCT). GPs in 37 practices (intervention n = 19; control n = 18) across the Netherlands recruited 224 children with GP-confirmed AOM and ear pain (intervention n = 94; control n = 130) between February 2015 and May 2018.MethodGPs in practices allocated to the intervention group were trained (online and face-to-face) to discuss pain management with parents using an information leaflet, and prompted to prescribe weight-appropriate dosed paracetamol. Ibuprofen was additionally prescribed if pain control was still insufficient. GPs in the control group provided usual care.ResultsMean ear pain scores over the first 3 days were similar between groups (4.66 versus 4.36; adjusted mean difference = −0.05; 95% confidence intervals [CI] = −0.93 to 0.83), whereas analgesic use, in particular ibuprofen, was higher in the intervention group. The total number of antibiotic prescriptions during the 28-day follow-up was similar (mean rate 0.43 versus 0.47; adjusted rate ratio [aRR] 0.97; 95% CI = 0.68 to 1.38). Parents of children in the intervention group were more likely to reconsult for AOM-related complaints (mean rate 0.70 versus 0.41; aRR 1.73; 95% CI = 1.14 to 2.62).ConclusionAn intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit. GPs are advised to carefully weigh the potential benefits of ibuprofen against its possible harms.

Highlights

  • Ear pain is the predominant symptom of childhood acute otitis media (AOM)[1] and central to children’s and parents’ experience of the illness.[2]

  • Mean ear pain scores over the first 3 days were similar between groups (4.66 versus 4.36; adjusted mean difference = –0.05; 95% confidence intervals [CI] = –0.93 to 0.83), whereas analgesic use, in particular ibuprofen, was higher in the intervention group

  • Parents of children in the intervention group were more likely to reconsult for AOM-related complaints

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Summary

Introduction

Ear pain is the predominant symptom of childhood acute otitis media (AOM)[1] and central to children’s and parents’ experience of the illness.[2]. The PIPS study[9] found increased doctor reconsultations and complications, and the Internet Doctor trial found more prolonged illness, both as a result of NSAID prescribing.[10] Recent trials in urinary tract infection (UTI)[11,12,13] suggest higher complication rates may result from treating UTI with NSAIDs, and there is mounting observational evidence that the use of NSAIDs for infections may result in harm.[14,15,16,17] In children with AOM who experience insufficient pain relief with paracetamol alone (in weight-appropriate doses), the added benefit of ibuprofen remains unclear. Pain management in acute otitis media (AOM) is often suboptimal, potentially leading to unnecessary discomfort, GP reconsultation, and antibiotic prescribing

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