Do anaesthetic ear drops reduce antibiotic consumption and ear pain in children presenting to primary care with acute otitis media? A three arm (placebo and usual care controlled) randomised trial.
Improving antibiotic stewardship is an international priority. Acute otitis media (AOM) is a common, distressing condition of childhood, frequently leading to primary care consultations and antibiotic prescribing. Current guidelines recommend 'no' or 'delayed' antibiotics for the majority, and encourage parents to manage the pain with oral analgesics. However, many parents report poor pain control and give antibiotics. In the first randomised controlled study to be conducted in European primary care, we hypothesised that anaesthetic ear drops would reduce antibiotic consumption (main study aim) and ear pain (key secondary objective) in children with AOM.
Design: multi-centre, randomised, parallel three-group (anaesthetic drops, placebo drops and usual care) trial set in UK primary care (ISRCTN09599764). Due to placebo supply problems, recruitment was initially restricted to two groups (anaesthetic drops and usual care). Eligibility: age one to ten-years; presenting within one week of suspected AOM; ear pain during the preceding 24 hours; and not thought to require immediate antibiotics. Interventions: two-group trial: (i) anaesthetic ear drops; (ii) usual care. Three-group trial: (i) anaesthetic ear drops; (ii) usual care; (iii) placebo ear drops. Outcomes: primary - parent reported antibiotic use at one week; key secondary outcome - parent reported ear pain (zero to 10 scale) at the end of day 2.
Due to a delay in provision of the placebo drops and lower than excepted antibiotic consumption in the usual care group, recruitment was curtailed with 74 and 32 children randomly allocated to the two- and three-group trials (original overall sample size target 450). Comparing active drops to usual care in the combined two- and three-group trials, 1/39 (3%) children allocated to active drops, and 11/38 (29%) children allocated to usual care, consumed antibiotics at one week (unadjusted OR 0.09, 95% CI 0.02 to 0.55, p=0.009; adjusted for delayed prescribing OR 0.13, 95% CI 0.01 to 1.13, p=0.064). In the three-group study, there was no evidence of a reduction in ear pain at day 2 comparing active with placebo drops group (adjusted difference in means -0.67, 95% CI -2.79 to 1.44, p=0.83).
Despite lower than expected recruitment and statistical power, the study provides modest evidence that anaesthetic ear drops reduce antibiotic consumption. Further research is needed to replicate effects on antibiotic consumption and to further investigate effects on pain. Anaesthetic ear drops remain a promising, novel treatment with the potential to transform the management of AOM in children.