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Water Precautions and Tympanostomy Tubes: A Randomized, Controlled Trial

Authors

  • Nira A. Goldstein MD,

    Corresponding author
    1. ENT Research Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.
    2. Department of Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.
    Current affiliation:
    1. Dr. Goldstein is currently with the Division of Pediatric Otolaryngology, State University of New York Downstate Medical Center, Brooklyn, New York.
    • Nira A. Goldstein, MD, Division of Pediatric Otolaryngology, State University of New York Downstate Medical Center, 450 Clarkson Avenue, Box 126, Brooklyn, New York 11203, U.S.A.
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  • Ellen M. Mandel MD,

    1. ENT Research Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.
    2. Department of Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.
    3. Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, U.S.A.
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  • Marcia Kurs-Lasky MS,

    1. Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, U.S.A.
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  • Howard E. Rockette PhD,

    1. Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, U.S.A.
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  • Margaretha L. Casselbrant MD, PhD

    1. ENT Research Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.
    2. Department of Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.
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  • Presented in part at the 16th Annual Meeting of the American Society of Pediatric Otolaryngology, Scottsdale, AZ, May 10, 2001.

    Supported by grants from the Children's Hospital of Pittsburgh General Clinical Research Center (5M01 RR00084) and the Children's Hospital of Pittsburgh Research Advisory Committee SEED Money (n.a.g.).

Abstract

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.

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