Management of middle-ear effusions in children.

A double-blind placebo controlled trial of Mucodyne (carbocisteine, Berk Pharmaceuticals), Actifed (triprolidine HC1 and pseudoephedrine HC1, Wellcome) and combined Mucodyne and Actifed in the treatment of middle-ear effusions is reported. The trial was undertaken to assess whether either preparation, alone or in combination, would reduce the number of children requiring surgical treatment for this condition. No statistical difference between the various groups in avoiding surgical treatment was detected. In those patients undergoing surgery, pre-operative treatment with Mucodyne was associated with a significantly greater number of ears restored to a normal appearance and middle ear function as measured by tympanometry. All patients relapsing after surgery belonged to the groups receiving placebo, Actifed or the combination of Mucodyne and Actifed prior to the operation.

RCT Entities:   Population Interventions Outcomes