title: The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial.
abstract: Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.
authors.affiliation: Southmead Hospital, North Bristol NHS Trust, Bristol, UK. arvind7@tesco.net
authors.forename: A K
authors.initials: AK
authors.lastname: Arya
authors.forename: P A
authors.initials: PA
authors.lastname: Rea
authors.forename: P J
authors.initials: PJ
authors.lastname: Robinson
mesh_terms: D000287:Administration, Topical; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002675:Child, Preschool; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005601:Framycetin / Q000008:administration & dosage / Q000627:therapeutic use*; D006096:Gramicidin / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D008876:Middle Ear Ventilation / Q000009:adverse effects*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies
chemical_list: D000890:Anti-Infective Agents; D004338:Drug Combinations; D006096:Gramicidin; D005601:Framycetin; C023881:Sofradex; D003907:Dexamethasone