Objective - To assess the effectiveness of a homeopathic ear drop for treatment of otalgia in children with acute otitis media (AOM).Methods - Children with AOM were enrolled in the study at the time of diagnosis and randomized to receive either standard therapy alone or standard therapy plus a homeopathic ear drop solution that was to be used on as needed basis for up to 5 days. Parents of children in both treatment groups rated the severity of 5 AOM symptoms twice daily for 5 days in a symptom diary. A symptom score was computed for each assessment with lower scores denoting less severe symptoms. Parents of children randomized to receive ear drops also recorded information regarding symptoms being treated and response to treatment.Results - A total of 119 eligible children were enrolled in the study; symptom diaries were received from 94 (79%). Symptom scores tended to be lower in the group of children receiving ear drops than in those receiving standard therapy alone; these differences were significant at the second and third assessments (P = 0.04 and P = 0.003, respectively). In addition, the rate of symptom improvement was faster in children in the ear drop group compared with children in standard therapy alone group (P = 0.002). The most common reason for administration of ear drops was ear pain, recorded for 93 doses; improvement was noted after 78.4% of doses for this indication. There were no significant side effects related to use of the ear drops.Conclusions - This study suggests that homeopathic ear drops were moderately effective in treating otalgia in children with AOM and may be most effective in the early period after a diagnosis of AOM. Pediatricians and other primary health care providers should consider homeopathic ear drops a useful adjunct to standard therapy.