Background: The prevention of otitis media, particularly among infants, remains a controversial issue. We evaluated the efficacy of insertion of tympanostomy tubes with and without adenoidectomy for preventing recurrent acute otitis media (AOM) in young children.
Methods: We randomly assigned 300 children aged 10 months to 2 years who had recurrent AOM to groups receiving tympanostomy tubes (Tymp) (n = 100), tympanostomy tubes with adenoidectomy (TympAde) (n = 100) or neither (Contr) (n = 100). All the children were followed up for 12 months.
Results: The primary outcome was intervention failure (2 AOM episodes in 2 months, 3 in 6 months or persistent effusion lasting for 2 months). Intervention failed in 21% of cases (21/100) in the Tymp group, 16% (16/100) in the TympAde group and 34% (34/100) in the Contr group. The absolute differences were -13% [95% confidence interval (CI) -25% to -1%, P = 0.04] between the Tymp and Contr groups and -18% (95% CI -30 to -6%, P =0.004) between the TympAde and Contr groups.
Conclusions: Insertion of tympanostomy tubes alone or with adenoidectomy was effective in preventing recurrent AOM episodes in children younger than 2 years of age.
Trial registration: ClinicalTrials.gov NCT00162994.