The use of perioperative SofradexR 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.

Common agents used to unblock blood clots within tympanostomy tubes: An ex vivo study and review of literature

“…A recent study (2005) examined antibiotic drops and oxymetazoline in the immediate postoperative period and observed blockage rates showed no difference in the rate of postoperative otorrhea or tube patency, indicating that oxymetazoline and antibiotic drops have equal efficacy for this purpose [3]. Other studies comparing antibiotic drops vs. no drops have had conflicting results; while one study showed a significant decrease in postoperative otorrhea (p < 0.01), but no effect on postoperative blood clot blockage (p > 0.05) [9]; the other showed a significant decrease in postoperative TT blockage using perioperative antibiotic drops [8].…”

“…Many studies have been undertaken in the in vivo model, testing differing solutions [3,[7][8][9]. A recent study (2005) examined antibiotic drops and oxymetazoline in the immediate postoperative period and observed blockage rates showed no difference in the rate of postoperative otorrhea or tube patency, indicating that oxymetazoline and antibiotic drops have equal efficacy for this purpose [3].…”

A randomised clinical trial of single or extended dosing ciprofloxacin versus no intervention for prevention of ventilation tube otorrhoea and obstruction (PreVenTO2)

“…Similar to our study, they found a statistically significant reduction in the rate of otorrhoea with the use of OTO‐201. In contrast, two other studies found no difference in incidence of VTO at 6 weeks between groups randomised to a single dose of Sofradex and no drops 23,27 . It is possible, however, that despite rigorous methodology, smaller sample sizes may not have been sufficient to capture group differences.…”

A simple method to prevent the obstruction of post-tympanoplasty ventilation tubes

“…The simultaneous insertion of ventilation tubes during tympanoplasty is carried out with the aim of providing prolonged middle-ear ventilation and preventing recurrent atelectasis 1 , 2 . The routine post-operative use of eardrops to help prevent ventilation tube obstruction has been described, but cannot be applied in a similar manner to post-tympanoplasty grommets as the ear canal remains packed with dressings for several weeks post-operatively 3 …”