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A randomized double‐blind controlled trial of phosphorylcholine‐coated tympanostomy tube versus standard tympanostomy tube in children with recurrent acute and chronic otitis media
Author(s) -
Hong Paul,
Smith Neil,
Johnson Liane B.,
Corsten Gerard
Publication year - 2011
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.21156
Subject(s) - medicine , grommet , randomized controlled trial , otitis , surgery , phosphorylcholine , tympanostomy tube , effusion , incidence (geometry) , complication , anesthesia , biochemistry , chemistry , physics , structural engineering , optics , engineering
Objective: To compare the postoperative complication rates of phosphorylcholine‐coated fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy tubes. Methods: 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. Results: 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. Conclusions: Phosphorylcholine‐coated fluoroplastic ventilation tubes do not offer any advantages over uncoated standard fluoroplastic tympanostomy tubes. Laryngoscope, 2011