An RCT 1 enrolled 283 children aged 6 months to 12 years at the emergency department of an academic hospital to receive antibiotics (mostly amoxycillin) either with instruction to start treatment immediately (standard prescription, SP) or to fill the prescription only if the child is not better or is worse 48 hours after today's visit (wait-and-see prescription, WASP). Children who appeared "toxic" as determined by the clinician were excluded. The otitis was unilateral in 83% in the SP group and 85% in the WASP group. All patients received ibuprofen and otic analgesic drops for use at home. More patients in the WASP group did not fill the prescription (62% vs 13%). There was no statistically significant difference between the groups in the frequency of subsequent fever, otalgia, or unscheduled visits.
A total of 223 children aged 6 months to 12 years with non-severe otitis media (assessed using an AOM-severity screening index) were randomized to immediate antibiotics (ABX) or watchful waiting (WW) 2. Of the children in the WW group, 66% completed the study without needing antibiotics. Compared with WW, symptom scores on days 1 to 10 resolved faster in subjects treated with immediate ABX. At day 12, among the immediate-ABX group, 69% of tympanic membranes and 25% of tympanograms were normal, compared with 51% of normal tympanic membranes and 10% of normal tympanograms in the WW group. Parent satisfaction with AOM care was not different between the 2 treatment groups at either day 12 or 30.
In an open RCT 3 315 children aged 6 months to10 years presenting with acute otitis media received either immediate antibiotics or delayed antibiotics (to be collected at the parents' discretion after 72 hours if the child was still not improving). 76% of the children in the delayed antibiotics group did not receive antibiotics, and 77% of the parents were very satisfied. Children prescribed antibiotics immediately had shorter illness (-1.1 days, 95% CI -0.54 to -1.48), fewer nights disturbed (-0.72, 95% CI -0.30 to -1.13), and slightly less paracetamol consumption (-0.52 spoons/day, 95% CI -0.26 to -0.79).
A Cochrane review 4 included four trials (1007 children), that compared immediate antibiotic treatment versus observation. No difference in pain was detectable at three to seven days (RR 0.75; 95% CI 0.50 to 1.12) and 11 to 14 days (RR 0.91, 95% CI 0.75 to 1.10) between immediate antibiotic treatment and expectant observation (observation with or without an antibiotic prescription). No serious complications occurred in either the antibiotic group or the expectant observation group. Additionally, no differences in the number of children with abnormal tympanometry findings at 4 weeks, tympanic membrane perforations and AOM recurrence was observed. Immediate antibiotic prescribing was associated with a substantial increased risk of vomiting, diarrhoea or rash as compared with expectant observation (RR 1.71; 95% CI 1.24 to 2.36; NNTH 9).
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