ADENOIDECTOMY FOR OTITIS MEDIA IN 2/3 YEAR OLD CHILDREN

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DESCRIPTION: Efficacy of adenoidectomy for the treatment and prevention of otitis media with effusion has been shown for children four years and older. In their "Clinical Practice Guidelines, Otitis Media with Effusion in Young Children", the Agency for Health Care Policy and Research of the U.S. Department of Health and Human Services concluded that "Adenoidectomy is not recommended for treatment of OME in a child age 1 through 3 years in the absence of specific adenoid pathology". This conclusion was based on the Panel's finding no clinical trials to support any judgement as to the efficacy of adenoidectomy in the primary management of otitis media with effusion in very young children, coupled with the risk of postoperative bleeding. By means of a well designed large-scale randomized controlled trial, the efficacy of adenoidectomy and myringotomy with and without tympanotomy tube insertion will be compared with that of myringotomy and tympanotomy alone in reducing the morbidity of bilateral otitis media with effusion of at least 3 months's duration associated with hearing loss (>20 dB) in children ages 2 and 3 years. The primary outcome measure will be percentage of time with middle ear effusion. Rates of episodes of acute otitis media, otorrhea, and otitis media with effusion, time to first recurrence, number of surgical procedures, treatment failures, hearing status, and other sequelae and complications will be recorded and compared among the three treatment groups. We estimate that 63 evaluable subjects need to be entered in each treatment arm to have a 90 percent power of detecting a benefit of at least 0.30 in percentage of time with middle ear effusion. The outcome of this trial should resolve the question of efficacy of adenoidectomy for otitis media with effusion in this age group.