Post‐Tympanostomy Otorrhea: A Randomized Clinical Trial of Topical Prophylaxis

Abstract

Myringotomy with the insertion of tympanostomy tubes has become the most frequently performed otolaryngologic procedure, and otorrhea is the most common post-tympanostomy complication. Many otolaryngologists routinely use prophylactic topical antibiotic solutions when performing tympanostomy tube placement. Relatively little has been written regarding early post-tympanostomy otorrhea and scarcely any examining the efficacy of such prophylaxis. The current study is a randomized clinical trial to critically evaluate the efficacy of prophylactic otic drops after tympanostomy tube placement. The ototoxic potential of these solutions, combined with constant pressures to decrease medication expenses and eliminate unnecessary use of antibiotics, makes determination of the shortest effective course of application paramount. Subjects were randomized at the time of surgery into one of three groups: one group received no prophylaxis, a second group received gentamicin otic drops immediately after tympanostomy tube placement in the operating room only, and the third group received an additional 48 hours of drops (4 drops in each ear, three times a day). All patients were seen within 2 weeks postoperatively. An overall early post-tympanostomy otorrhea incidence of 8.7% is documented with 12%, 8.8%, and 5.6% for each study group, respectively. While these findings may suggest possible efficacy of topical prophylaxis, a statistically significant difference between the treatment groups was not proved (p = 0.62). Further analysis by subdivision of the patients, on the basis of middle ear cavity finding at the time of surgery, reveals a highly significant statistical association of the occurrence of post-tympanostomy otorrhea in ears having mucoid effusions (p less than 0.001) as compared to ears without effusion or with serous effusions.(ABSTRACT TRUNCATED AT 250 WORDS)

Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement

“…The rate of otorrhea in the control group of our study was 39.39%, higher than observed in the control group of other prospective trials, 10-30% [5][6][7][8][9][10][11][12][13]. Part of the explanation for this difference was that we analyzed the patient as a whole instead of ''per-ear''.…”

“…In addition, some patients are unable to attend daycare/school settings with otorrhea, affecting quality of life. Several prospective studies using ototopical agents have shown a reduction in postoperative otorrhea [5][6][7][8][9][10][11][12][13][14]. In a meta-analysis of five Decrease in incidence of otorrhea with ciprofloxacin/dexamethasone drops prospective studies, ototopical antibiotics or antibiotic/steroid combinations administered perioperatively resulted in a reduction of post-operative otorrhea with the greatest benefit in patients with infection or purulent effusion at the time of surgery [4].…”

“…Many trials have studied the impact of ototopical agents on the rate of otorrhea in the post-operative period [5][6][7][8][9][10][11][12][13][14]. These studies have been conducted in patients at University academic settings.…”

Grommets in otitis media with effusion: the most frequent operation in children. But is it associated with significant complications?

“…A distinction should be made between early otorrhea, which appears within 2-4 weeks after the operation, and delayed otorrhea, which occurs several months postoperatively [40]. The prevalence of early otorrhea ranges from 10 to 20% [4,5,19,22,26,36,57,65,66,81], whereas delayed otorrhea seems to be more frequent, occurring in 26% of cases [36]. Other studies have reported even higher rates of otorrhea, up to 50% of cases within a 3-year observation period [41,42] and even 83% in a study on children up to 36 months old at the time of insertion.…”

“…The routine perioperative prophylactic use of local antibiotic ear drops flies in the face of evidence-based [19,66,81] A related meta-analysis found an 85% reduction of otorrhea when perioperative antibiotic drops were used [21], but the low incidence of this complication and the heterogeneity of the published studies prevented the authors from drawing a final conclusion; they therefore recommended the judicious use of these agents, with emphasis on those cases at higher risk of otorrhea, namely those with mucoid or purulent effusion. In terms of preventing biofilm formation, emphasis has been placed on the effect of a surface treatment of fluoroplastic grommets.…”