Background: Watchful waiting with the option of delayed antimicrobial treatment for acute otitis media is recommended in several guidelines. Our aim was to study whether delayed, as compared with immediate, initiation of antimicrobial treatment worsens the recovery from acute otitis media in young children.
Methods: Children (6-35 months) with acute otitis media received either delayed or immediate antimicrobial treatment with amoxicillin-clavulanate for 7 days. The delayed antimicrobial treatment group (n = 53) consisted of placebo recipients from a randomized-controlled trial to whom antimicrobial treatment was initiated after a watchful waiting period. The immediate antimicrobial treatment group (n = 161) consisted of children allocated to receive antimicrobial treatment immediately.
Results: Improvement during antimicrobial treatment (which includes both symptoms and otoscopic signs) was observed in 91% and 96% of children in the delayed and immediate antimicrobial treatment groups, respectively (P = 0.15). Median watchful waiting period was 48 hours. Delayed initiation of antimicrobial treatment was associated with prolonged resolution of fever, ear pain, poor appetite and decreased activity, but not ear rubbing, irritability, restless sleep or excessive crying. Parents of children in the delayed antimicrobial treatment group missed more work days (mean 2.1 versus 1.2 days, P = 0.03). Diarrhea, vomiting and rash were equally common in both groups.
Conclusions: Our results indicate that delayed initiation of antimicrobial treatment does not worsen the recovery from acute otitis media, as measured by improvement during treatment. However, watchful waiting before the initiation of delayed antimicrobial treatment might be associated with transient worsening of a child's condition, prolongation of symptoms and economic losses.