OBJECTIVE: Determine whether watchful waiting is non-inferior to immediate oral antibiotics for uncomplicated acute otitis media among urban Aboriginal and Torres Strait Islander children.
STUDY TYPE: Non-inferiority unblinded randomised controlled trial.
SETTING AND PARTICIPANTS: Eight Aboriginal Medical Services across three Australian states and territories between 25 August 2014 and 2 June 2023. Children (aged 1.5-16 years) with type B tympanograms and bulging tympanic membrane or acute pain/irritability were randomised by site and age (1.5-6 years and 7-16 years), with stratification using randomly allocated, permuted blocks of four and six in length.
MAIN OUTCOME MEASURES: Watchful waiting compared with immediate oral antibiotics using modified intention-to-treat (using only available data) and per-protocol analyses of Day 7 clinical resolution with non-inferiority threshold set at 10 percentage points.
RESULTS: Children were randomly allocated to watchful waiting (134), six of whom were lost to follow-up or immediate antibiotics (129) with three lost to follow-up. Resolution occurred in 57/106 (53.8%) watchful waiting and 68/113 (60.2%) immediate antibiotic group of those with complete Day 7 data (-6.4 percentage points difference; 90% confidence interval [CI], -17.4 to 4.6) (modified intention-to-treat analysis). Per-protocol analysis similarly demonstrated reduced resolution in the watchful waiting group (49/97; 50.5%) compared with immediate antibiotics (67/112; 59.8%) with -9.3 percentage points difference (90% CI, -20.6 to 2.0). There was less Day 3 diarrhoea in watchful waiting (3/90; 3.3%) than in the immediate antibiotic group (13/93 [14.0%]; -10.7 percentage points difference; 95% CI, -18.6 to -2.7) but no other differences in vomiting, diarrhoea or rash (Days 3-14). Day 7 analgesia use was higher in the watchful waiting (53/107 [49.5%]) than immediate antibiotic group (37/116 [31.9%]; 17.6 percentage points difference; 95% CI, 4.9 to 30.1). There were no intervention-related severe adverse events or perforations.
CONCLUSION: Although our results are numerically similar to those reported in other low-risk populations and no unexpected safety signals were observed in the watchful waiting arm, non-inferiority was not established. Larger, adequately powered trials are required to determine whether watchful waiting is non-inferior in this population.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN#12613001068752.
The: Acute otitis media is a common reason for childhood antibiotic prescriptions. Aboriginal and Torres Strait Islander children are at high risk of complications, yet management evidence from urban settings, where most live, is lacking. The New: Watchful waiting had slightly lower resolution and more analgesia use on Day 7, comparable with international studies of low‐risk children, although non‐inferiority was not demonstrated. There were no perforations or between‐group differences in Week 7 middle ear effusions. Parent/carers were equally satisfied with each option. The Implications: Watchful waiting is acceptable management for urban Aboriginal and Torres Strait Islander children with uncomplicated acute otitis media.