Effectiveness of analgesic ear drops as add-on treatment to usual care in children with acute otitis media: the OPTIMA pragmatic randomised controlled trial

BackgroundClinical practice guidelines recommend oral analgesics for all children with acute otitis media (AOM), and antibiotics for selected cases. Analgesic ear drops could be a promising add-on treatment, but evidence for their effectiveness is limited. Despite being available over-the-counter, they are rarely used in daily practice. AimTo establish whether analgesic ear drops added to usual care provides superior ear pain relief over usual care alone in children presenting to general practice with AOM. Design and settingPragmatic, open label, two arm, individually randomised, superiority trial in 35 general practices in the Netherlands between October 2021 and January 2024. MethodsChildren with AOM and ear pain were randomly allocated to either 1) lidocaine hydrochloride 5mg/g ear drops 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics with or without antibiotics) or 2) usual care. The primary outcome, parent-reported ear pain score (0-10) over the first 3 days, was analysed with a linear regression model accounting for repeated measurements, adjusting for time, baseline ear pain score, age [≤]2 vs >2 years, uni-vs bilateral AOM, and baseline antibiotic prescribing. Secondary outcomes were reported descriptively. ResultsWith 29 of a planned 300 children enrolled between Oct 2021 and Jan 2024 (15 intervention, 14 control; mean age 2.6 years (SD 1.5), 62% boys), the trial was ended prematurely due to slow accrual. Analyses were conducted for 28 participants with complete data. No significant difference in mean parent-reported pain scores over the first three days was observed between children receiving analgesic ear drops in addition to usual care and those receiving usual care alone (mean difference 0.14, 95% CI -2.00 to 2.28). Local discomfort and difficulties during administration of the analgesic ear drops were reported in 71.4% (10/14) and 50% (7/14) of children, respectively. ReflectionsEarly termination of this trial does not allow for conclusions on the effectiveness of analgesic ear drops as add-on treatment in children with AOM. Our experience underscores the substantial challenges of delivering prospective trials in general practice, and underlines the need for collaborative and viable recruitment infrastructures. Combining individual participant trial data from existing trials may help provide more robust conclusions. Trial registrationThe Netherlands Trial Register; NL9500. Date of registration: 28 May 2021.