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Am Fam Physician. 1998;57(5):1138-1140

Most children with acute otitis media have ear pain. Along with discomfort, otalgia results in fussiness, sleep disturbance and parental anxiety. However, the management of ear pain has been inadequately studied. Physicians commonly recommend acetaminophen, which has a slow onset of action and produces mixed results. A proprietary otic solution, consisting of a mixture of antipyrine, benzocaine and oxyquinolone sulfate dissolved in dehydrated glycerin, has been developed for instillation into the ear canal. It reputedly induces analgesia immediately after coming into contact with the tympanic membrane and has no reported side effects. Hoberman and associates compared the efficacy of this otic solution with an olive oil placebo for the management of pain in children with acute otitis media.

Children between five and 19 years of age presenting to the emergency department with ear pain and acute otitis media were eligible for the study. Children who had received analgesia at home or in the emergency department within the preceding five hours were excluded. The diagnosis of otitis media required the presence of pain with a middle ear effusion and at least one other indicator of acute inflammation, including marked redness, distinct bulging or fullness of the tympanic membrane. Two visual analog scales were used to assess ear pain and were first administered at the time of diagnosis to determine a baseline level of pain. Children receiving a score of 3 or greater were eligible for the study. A total of 54 children were enrolled in the study, with an equal number randomized to receive either five drops of the otic solution or five drops of olive oil. All of the children also received acetaminophen, 15 mg per kg, in a single dose. The visual analog scales were re-administered at 10, 20 and 30 minutes after the instillation of ear drops.

At entry, both groups had essentially the same baseline pain scores. After 10 minutes, 33 percent of the treatment group and 15 percent of the placebo group reported a 50 percent reduction in pain. At 20 minutes, 50 percent of patients in the treatment group versus 44 percent of patients in the placebo group reported a 50 percent reduction in pain. At 30 minutes, the difference was 78 percent for the group receiving the otic solution and 56 percent for the group receiving placebo. None of these differences were statistically significant. When ear pain reduction of 25 percent was assessed, the results also favored the group receiving the otic solution at 10, 20 and 30 minutes. The only difference that reached statistical significance was the number of patients (96 versus 70 percent) who achieved ear pain reduction of 25 percent at 30 minutes. A small number of children did report dramatic and immediate pain relief with the otic solution, whereas pain relief with the olive oil, when attained, was gradual. One patient receiving the otic solution and six patients receiving placebo reported no pain relief at the end of the evaluation period.

The authors conclude that in children with acute ear pain associated with otitis media, a topical otic solution provides adequate analgesia within 30 minutes of administration and, in some instances, much sooner, and appears to be superior to olive oil for this purpose.

editor's note: Acute ear pain results in many telephone calls to family physicians, not infrequently during the middle of the night or on weekends. Acetaminophen is usually recommended but has a slow onset of action (usually from 30 to 60 minutes) and thus often does not adequately relieve the child's pain or the parent's anxiety. A potential benefit to using a topical analgesic with a rapid onset of action for ear pain might be fewer phoned-in prescriptions for amoxicillin until the child can be examined. There may even be spontaneous remission in the interim, allowing the physician to forgo antibiotic therapy altogether.—j.k.

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