Lack of efficacy of middle-ear inflation: treatment of otitis media with effusion in children.

A randomized controlled trial was conducted to evaluate the efficacy of autoinflation of the middle ear in the treatment of otitis media with effusion. Forty-one children with middle ear effusion not responsive to antimicrobial therapy enrolled in the study. Of these subjects, 75 percent had effusion duration over 3 months. A system consisting of a disposable anesthesia mask attached to a flowmeter was used to teach children to perform autoinflation based on a modified Valsalva technique. Subjects were stratified according to their ability to achieve tubal opening as assessed by tympanometry and tubosonometry. Subjects were randomly assigned to either treatment or observation group and were followed weekly for 2 weeks; subjects in the treatment group attempted inflation three times each day for 2 weeks. Of the 19 subjects who were in the autoinflation group, only one (5.3 percent) was effusion-free at the two-week endpoint and of the 21 subjects in the control, only two (9.5 percent) were without middle-ear effusion. Autoinflation was ineffective for treatment of children with otitis media with effusion in our study.

RCT Entities:   Population Interventions Outcomes