Abstract
Objective To compare both approaches for the treatment of nonsevere acute otitis media (AOM) in Iran. Methods This randomized clinical trial was performed at a pediatric infectious diseases clinic in Buali tertiary hospital in Sari, north of Iran, from 2016 to 2018. All participants in this study were previously healthy children with AOM diagnosis, who were 6 months to 6 years old. The patients were randomly assigned into two groups: the intervention (80 mg/kg/day amoxicillin for 7-10 days) and the control group (watchful waiting approach). AOM recovery and adverse drug reactions were evaluated after 72 hours, and the patients were followed for the frequency of AOM and middle ear effusion 1 and 3 months' postintervention. Results A total of 396 children have participated in this study. AOM recovery was significantly different in the two groups (73% vs. 44% in the intervention and control groups, respectively). Recurrence of AOM and middle ear effusion (MEE) persistence, one month following the intervention, have not shown any significant differences between the two groups. However, the AOM recurrence between 1 and 3 months was more frequent in the control group. The frequency of diarrhea was also higher in the intervention group compared to the control but no significant difference was found between the two groups regarding vomiting and skin rash. Conclusion The faster recovery from AOM is achieved when an antibiotic treatment regimen is applied, although the risk of potential side effects should be considered.
Highlights
Acute otitis media (AOM) is one of the most common childhood diseases
Results of a study in Sweden showed that pneumococcal conjugate vaccines reduce the incidence of otitis media up to 26% and delay the first episode of otitis media in infants and young children [15]
Three days after the intervention, most of the complaints disappeared in both groups, but the improvements were more significant in the antibiotic group. 28 (15%) patients from the intervention group and 59 (28%) patients from the control group still had otalgia (P < 0:01). 35(19%) of the interventions and 92(44%) of the controls had a fever (P < 0:01), and 19 (10%) of the interventions and 40 (19%) of the controls had irritability (P < 0:05) (Table 2)
Summary
Acute otitis media (AOM) is one of the most common childhood diseases. 75% of children experience at least one episode of ear infection before starting their school [1, 2]. AOM is one of the leading causes of healthcare visits in many countries. The worldwide AOM rate is estimated to be about 10.85% (709 million cases) each year, from which 51% of them are under the age of five [3]. Gender, race, genetics, socioeconomic status, neonatal feeding, smoke exposure, day care attendance, season, and the midline facial defects are the most common factors affecting the rate of AOM infections in children [1, 3, 4]. Otitis media is more common in boys aged 6 to 20 months [5]
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