A randomized double-blind controlled trial of phosphorylcholine-coated tympanostomy tube versus standard tympanostomy tube in children with recurrent acute and chronic otitis media.

Abstract

To compare the postoperative complication rates of phosphorylcholine-coated fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy tubes. A prospective randomized double-blind controlled trial in children with recurrent acute otitis media and chronic otitis media with effusion; 240 children were randomized to receive a phosphorylcholine-coated tube in one ear and an uncoated tube in the other. Postoperatively, patients were assessed at 2 weeks and 4, 8, 12, 18, and 24 months to ascertain the incidence of otorrhea, tube lumen blockage, and early extrusion. Out of 240 children, 5 withdrew and 16 were lost to early follow-up. The mean age was 43.8 months. There were no statistically significant differences in the incidence of postoperative otorrhea, tube blockage, and extrusion. Phosphorylcholine-coated fluoroplastic ventilation tubes do not offer any advantages over uncoated standard fluoroplastic tympanostomy tubes.