David P. Losh, MD

BACKGROUND: Most patients who present with AOM receive antibiotics despite current controversy over whether antibiotics actually benefit patients. Health care providers have to balance concerns about antibiotic resistance with those regarding parental satisfaction.

POPULATION STUDIED: The study included 315 children aged 6 months to 10 years from general outpatient practices in southwest England who presented with acute ear pain with erythema, bulging, or perforation of the tympanic membrane on otoscopic examination. Children were excluded if they had pink tympanic membranes consistent with fever or crying alone, a history and examination consistent with otitis media with effusion and chronic suppurative otitis media, serious chronic disease, antibiotic use within the previous 2 weeks, previous complications of AOM, or if they appeared toxic.

STUDY DESIGN AND VALIDITY: This was a nonblinded controlled clinical trial with patients randomized to receive either immediate antibiotics (a prescription to be filled following the visit) or delayed antibiotics (instructions to return to clinic to pick up an prescription left at the reception desk in 3 days if the child was worse or not improving). When a patient was diagnosed with AOM, the physician opened an opaque envelope containing an advice sheet that allocated the patient to 1 of the 2 study groups. The advice sheet provided information on the benefits of the intervention, which the physician shared with the patient and parent to support the placebo effect of either intervention. The authors appropriately accounted for all study participants and used an intention-to-treat analysis.

OUTCOMES MEASURED: The authors measured duration and degree of pain, number of episodes of distress, amount of acetaminophen used, number of school days missed, and parental satisfaction scores as reported by parents in a daily diary.

RESULTS: Of 384 children eligible for the study, 315 were randomized, and 285 completed the study. A total of 132 of the 135 patients allocated to receive immediate antibiotics actually used them; 36 of the 150 children (24%) allocated to delayed prescription used antibiotics. Symptoms resolved in both groups in an average of 3 days. The children who received immediate antibiotics had significantly fewer days of earache (mean difference = -1.10 days; 95% confidence interval [CI], -0.54 to -1.48) and used fewer teaspoons of acetaminophen (mean difference = -0.52 tsp; 95% CI, -0.79 to -0.26). There was no difference between the 2 groups in mean pain scores, number of episodes of distress, or absence from school. Any effect of antibiotics seemed to occur only after the first 24 hours of illness. Diarrhea occurred in 19% of children who received antibiotics immediately, compared with 9% in the delayed group. Ninety-one percent of the parents in the immediate antibiotics group and 77% of those in the delayed antibiotics group were very satisfied with the treatment approach. Eighty-three percent of the parents whose children received antibiotics immediately believed that they would need to see the physician for future episodes, compared with 63% in the delayed antibiotics group; 76% versus 46% of parents in the immediate and delayed antibiotic groups, respectively, believed that antibiotics were very effective for AOM.

BACKGROUND: Most patients who present with AOM receive antibiotics despite current controversy over whether antibiotics actually benefit patients. Health care providers have to balance concerns about antibiotic resistance with those regarding parental satisfaction.

POPULATION STUDIED: The study included 315 children aged 6 months to 10 years from general outpatient practices in southwest England who presented with acute ear pain with erythema, bulging, or perforation of the tympanic membrane on otoscopic examination. Children were excluded if they had pink tympanic membranes consistent with fever or crying alone, a history and examination consistent with otitis media with effusion and chronic suppurative otitis media, serious chronic disease, antibiotic use within the previous 2 weeks, previous complications of AOM, or if they appeared toxic.

STUDY DESIGN AND VALIDITY: This was a nonblinded controlled clinical trial with patients randomized to receive either immediate antibiotics (a prescription to be filled following the visit) or delayed antibiotics (instructions to return to clinic to pick up an prescription left at the reception desk in 3 days if the child was worse or not improving). When a patient was diagnosed with AOM, the physician opened an opaque envelope containing an advice sheet that allocated the patient to 1 of the 2 study groups. The advice sheet provided information on the benefits of the intervention, which the physician shared with the patient and parent to support the placebo effect of either intervention. The authors appropriately accounted for all study participants and used an intention-to-treat analysis.

OUTCOMES MEASURED: The authors measured duration and degree of pain, number of episodes of distress, amount of acetaminophen used, number of school days missed, and parental satisfaction scores as reported by parents in a daily diary.

RESULTS: Of 384 children eligible for the study, 315 were randomized, and 285 completed the study. A total of 132 of the 135 patients allocated to receive immediate antibiotics actually used them; 36 of the 150 children (24%) allocated to delayed prescription used antibiotics. Symptoms resolved in both groups in an average of 3 days. The children who received immediate antibiotics had significantly fewer days of earache (mean difference = -1.10 days; 95% confidence interval [CI], -0.54 to -1.48) and used fewer teaspoons of acetaminophen (mean difference = -0.52 tsp; 95% CI, -0.79 to -0.26). There was no difference between the 2 groups in mean pain scores, number of episodes of distress, or absence from school. Any effect of antibiotics seemed to occur only after the first 24 hours of illness. Diarrhea occurred in 19% of children who received antibiotics immediately, compared with 9% in the delayed group. Ninety-one percent of the parents in the immediate antibiotics group and 77% of those in the delayed antibiotics group were very satisfied with the treatment approach. Eighty-three percent of the parents whose children received antibiotics immediately believed that they would need to see the physician for future episodes, compared with 63% in the delayed antibiotics group; 76% versus 46% of parents in the immediate and delayed antibiotic groups, respectively, believed that antibiotics were very effective for AOM.

BACKGROUND: Most patients who present with AOM receive antibiotics despite current controversy over whether antibiotics actually benefit patients. Health care providers have to balance concerns about antibiotic resistance with those regarding parental satisfaction.

POPULATION STUDIED: The study included 315 children aged 6 months to 10 years from general outpatient practices in southwest England who presented with acute ear pain with erythema, bulging, or perforation of the tympanic membrane on otoscopic examination. Children were excluded if they had pink tympanic membranes consistent with fever or crying alone, a history and examination consistent with otitis media with effusion and chronic suppurative otitis media, serious chronic disease, antibiotic use within the previous 2 weeks, previous complications of AOM, or if they appeared toxic.

STUDY DESIGN AND VALIDITY: This was a nonblinded controlled clinical trial with patients randomized to receive either immediate antibiotics (a prescription to be filled following the visit) or delayed antibiotics (instructions to return to clinic to pick up an prescription left at the reception desk in 3 days if the child was worse or not improving). When a patient was diagnosed with AOM, the physician opened an opaque envelope containing an advice sheet that allocated the patient to 1 of the 2 study groups. The advice sheet provided information on the benefits of the intervention, which the physician shared with the patient and parent to support the placebo effect of either intervention. The authors appropriately accounted for all study participants and used an intention-to-treat analysis.

OUTCOMES MEASURED: The authors measured duration and degree of pain, number of episodes of distress, amount of acetaminophen used, number of school days missed, and parental satisfaction scores as reported by parents in a daily diary.

RESULTS: Of 384 children eligible for the study, 315 were randomized, and 285 completed the study. A total of 132 of the 135 patients allocated to receive immediate antibiotics actually used them; 36 of the 150 children (24%) allocated to delayed prescription used antibiotics. Symptoms resolved in both groups in an average of 3 days. The children who received immediate antibiotics had significantly fewer days of earache (mean difference = -1.10 days; 95% confidence interval [CI], -0.54 to -1.48) and used fewer teaspoons of acetaminophen (mean difference = -0.52 tsp; 95% CI, -0.79 to -0.26). There was no difference between the 2 groups in mean pain scores, number of episodes of distress, or absence from school. Any effect of antibiotics seemed to occur only after the first 24 hours of illness. Diarrhea occurred in 19% of children who received antibiotics immediately, compared with 9% in the delayed group. Ninety-one percent of the parents in the immediate antibiotics group and 77% of those in the delayed antibiotics group were very satisfied with the treatment approach. Eighty-three percent of the parents whose children received antibiotics immediately believed that they would need to see the physician for future episodes, compared with 63% in the delayed antibiotics group; 76% versus 46% of parents in the immediate and delayed antibiotic groups, respectively, believed that antibiotics were very effective for AOM.