OBJECTIVES/HYPOTHESIS: The objective was to determine whether there is an increased incidence of otorrhea in young children with tympanostomy tubes who swim and bathe without water precautions as compared with children who use water precautions in the form of ear plugs. STUDY DESIGN: Prospective, randomized, investigator-blinded, controlled trial. METHODS:Two hundred one children (age range, 6 mo-6 y) who had undergone bilateral myringotomy and tube insertion were randomly assigned into one of two groups: swimming and bathing with or without ear plugs. Children were seen monthly for 1 year and whenever there was intercurrent otorrhea. RESULTS:Ninety children with and 82 children without ear plugs returned for at least one follow-up visit. Mean (SD) duration of follow-up was 9.4 (4.1) months for the children with ear plugs and 9.1 (4.4) months for the children without ear plugs. Forty-two children (47%) who wore ear plugs developed at least one episode of otorrhea, as compared with 46 (56%) who did not use ear plugs (logistic regression adjusting for stratification variables, P = .21). The mean (SD) rate of otorrhea per month was 0.07 (0.31) for the children who wore ear plugs as compared with 0.10 (0.31) for the children who did not wear ear plugs (Poisson regression adjusting for stratification variables, P = .05). CONCLUSION: There is a small but statistically significant increase in the rate of otorrhea in young children who swim and bathe without the use of ear plugs as compared with children who use ear plugs. Because the clinical impact of using ear plugs is small, their routine use may be unnecessary.
RCT Entities:
OBJECTIVES/HYPOTHESIS: The objective was to determine whether there is an increased incidence of otorrhea in young children with tympanostomy tubes who swim and bathe without water precautions as compared with children who use water precautions in the form of ear plugs. STUDY DESIGN: Prospective, randomized, investigator-blinded, controlled trial. METHODS: Two hundred one children (age range, 6 mo-6 y) who had undergone bilateral myringotomy and tube insertion were randomly assigned into one of two groups: swimming and bathing with or without ear plugs. Children were seen monthly for 1 year and whenever there was intercurrent otorrhea. RESULTS: Ninety children with and 82 children without ear plugs returned for at least one follow-up visit. Mean (SD) duration of follow-up was 9.4 (4.1) months for the children with ear plugs and 9.1 (4.4) months for the children without ear plugs. Forty-two children (47%) who wore ear plugs developed at least one episode of otorrhea, as compared with 46 (56%) who did not use ear plugs (logistic regression adjusting for stratification variables, P = .21). The mean (SD) rate of otorrhea per month was 0.07 (0.31) for the children who wore ear plugs as compared with 0.10 (0.31) for the children who did not wear ear plugs (Poisson regression adjusting for stratification variables, P = .05). CONCLUSION: There is a small but statistically significant increase in the rate of otorrhea in young children who swim and bathe without the use of ear plugs as compared with children who use ear plugs. Because the clinical impact of using ear plugs is small, their routine use may be unnecessary.