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Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration.
Pediatrics 2001 June
OBJECTIVE: To characterize the occurrence of tube otorrhea after tympanostomy-tube placement (TTP) for persistent middle-ear effusion (MEE) in a group of otherwise healthy infants and young children.
METHODS: In a long-term, prospective study of child development in relation to early-life otitis media, we enrolled by 2 months of age healthy infants who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric group practices. We monitored their middle-ear status closely. Children who developed persistent MEE of specified durations within the first 3 years of life became eligible for random assignment to undergo TTP either promptly or after an extended period if MEE persisted. The present report concerns 173 randomly assigned children who underwent bilateral TTP between ages 6 and 36 months and were followed for at least 6 months thereafter. Episodes of tube otorrhea were treated with oral antimicrobial drugs and, if persistent, with ototopical medication.
RESULTS: Socioeconomic status, as estimated from maternal education and type of health insurance, was lowest at the urban sites and highest at the suburban sites. The tenure of the 230 tubes that were extruded during the observation period ranged from 19 days to 38.5 months (mean = 13.8 months; median = 13.5 months). During the first 18 months after TTP, the proportion of children who had tubes in place and who developed 1 or more episodes of otorrhea increased progressively, reaching 74.8% after 12 months and 83.0% after 18 months. The mean number of episodes per child was 0.79 in the first 6 months, 1.50 in the first 12 months, 2.17 in the first 18 months, and 2.82 in the first 24 months. Overall, otorrhea occurred earliest and was most prevalent among urban children and occurred latest and was least prevalent among suburban children. The mean estimated duration of episodes of tube otorrhea was 16.0 days (standard deviation = 16.9 days), the median was 10 days, and the range was 3 to 131 days. The duration was >30 days in 13.2% of the episodes. Six of the 173 children (3.5%) developed on 1 or more occasions tube otorrhea that failed to improve satisfactorily with conventional outpatient management. Five of these children were hospitalized to receive parenteral antibiotic treatment, 1 child twice and 1 three times, and 1 also underwent tube removal. The sixth child underwent tube removal as an outpatient.
CONCLUSIONS: Tube otorrhea is a common and often recurrent and/or stubborn problem in young children who have undergone tube placement for persistent MEE. The extent of the problem seems to be related inversely to socioeconomic status. Tube otorrhea does not always respond satisfactorily to outpatient management and for resolution may require parenteral antimicrobial treatment and/or tube removal.
METHODS: In a long-term, prospective study of child development in relation to early-life otitis media, we enrolled by 2 months of age healthy infants who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric group practices. We monitored their middle-ear status closely. Children who developed persistent MEE of specified durations within the first 3 years of life became eligible for random assignment to undergo TTP either promptly or after an extended period if MEE persisted. The present report concerns 173 randomly assigned children who underwent bilateral TTP between ages 6 and 36 months and were followed for at least 6 months thereafter. Episodes of tube otorrhea were treated with oral antimicrobial drugs and, if persistent, with ototopical medication.
RESULTS: Socioeconomic status, as estimated from maternal education and type of health insurance, was lowest at the urban sites and highest at the suburban sites. The tenure of the 230 tubes that were extruded during the observation period ranged from 19 days to 38.5 months (mean = 13.8 months; median = 13.5 months). During the first 18 months after TTP, the proportion of children who had tubes in place and who developed 1 or more episodes of otorrhea increased progressively, reaching 74.8% after 12 months and 83.0% after 18 months. The mean number of episodes per child was 0.79 in the first 6 months, 1.50 in the first 12 months, 2.17 in the first 18 months, and 2.82 in the first 24 months. Overall, otorrhea occurred earliest and was most prevalent among urban children and occurred latest and was least prevalent among suburban children. The mean estimated duration of episodes of tube otorrhea was 16.0 days (standard deviation = 16.9 days), the median was 10 days, and the range was 3 to 131 days. The duration was >30 days in 13.2% of the episodes. Six of the 173 children (3.5%) developed on 1 or more occasions tube otorrhea that failed to improve satisfactorily with conventional outpatient management. Five of these children were hospitalized to receive parenteral antibiotic treatment, 1 child twice and 1 three times, and 1 also underwent tube removal. The sixth child underwent tube removal as an outpatient.
CONCLUSIONS: Tube otorrhea is a common and often recurrent and/or stubborn problem in young children who have undergone tube placement for persistent MEE. The extent of the problem seems to be related inversely to socioeconomic status. Tube otorrhea does not always respond satisfactorily to outpatient management and for resolution may require parenteral antimicrobial treatment and/or tube removal.
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