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Acute red ear in children: controlled trial of non-antibiotic treatment in general practice
1Primary Medical Care Group, University of Southampton, Aldermoor Health Centre.
Insights
Antibiotic treatment significantly reduces treatment failure in children with mild otitis media (acute red ear). This approach improves short-term outcomes, making it an appropriate management strategy for this common childhood infection.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Otitis media, commonly known as the "acute red ear," is a frequent childhood illness.
- Conservative management strategies are often considered for mild cases.
Purpose of the Study:
- To evaluate the efficacy and safety of conservative management versus antibiotic intervention for mild otitis media in children.
- To compare treatment outcomes, symptom duration, and recurrence rates.
Main Methods:
- A double-blind, placebo-controlled trial involving 232 children aged 3-10 years with mild otitis media.
- Participants received either amoxycillin or a placebo for seven days, with paracetamol as an analgesic.
- Outcomes were assessed through diary records, tympanometry, and follow-up for one year.
Main Results:
- Antibiotic treatment resulted in significantly lower treatment failure rates (1.7% vs 14.4%) compared to placebo.
- The placebo group experienced higher rates of fever, increased analgesic use, longer crying duration, and more school absences.
- No significant differences were observed in middle ear effusion prevalence, recurrence rates, or ENT referrals between groups.
Conclusions:
- Antibiotic use substantially improves short-term outcomes for children with mild otitis media.
- Current antibiotic management policies are deemed appropriate based on these findings.
- No predictive factors for adverse outcomes were identified.
Objective:
To examine the efficacy and safety of conservative management of mild otitis media ("the acute red ear") in children.
Design:
Double blind placebo controlled trial.
Setting:
17 group general practices (48 general practitioners) in Southampton, Bristol, and Portsmouth.
Patients:
232 children aged 3-10 years with acute earache and at least one abnormal eardrum (114 allocated to receive antibiotic, 118 placebo).
Interventions:
Amoxycillin 125 mg three times a day for seven days or matching placebo; 100 ml paracetamol 120 mg/5 ml.
Main Outcome Measures:
Diary records of pain and crying, use of analgesic, eardrum signs, failure of treatment, tympanometry at one and three months, recurrence rate, and ear, nose, and throat referral rate over one year.
Results:
Treatment failure was eight times more likely in the placebo than the antibiotic group (14.4% v 1.7%, odds ratio 8.21, 95% confidence interval 1.94 to 34.7). Children in the placebo group showed a significantly higher incidence of fever on the day after entry (20% v 8%, p less than 0.05), mean analgesic consumption (0.36 ml/h v 0.21 ml/h, difference 0.14, 95% confidence interval 0.07 to 0.23; p = 0.0022), mean duration of crying (1.44 days v 0.50 days, 0.94; 0.50 to 1.38; p less than 0.001), and mean absence from school (1.96 days v 0.52 days, 1.45; 0.46 to 2.42; p = 0.0132). Differences in recorded pain were not significant. The prevalence of middle ear effusion at one or three months, as defined by tympanometry, was not significantly different, nor was there any difference in recurrence rate or in ear, nose, and throat referral rate in the follow up year. No characteristics could be identified which predicted an adverse outcome.
Conclusions:
Use of antibiotic improves short term outcome substantially and therefore continues to be an appropriate management policy.