In Children With Effusion Do Topical Antibiotics at Tympanostomy Tube Reduce Postoperative Otorrhea?

Tympanostomy tube insertion is one of the most common procedures performed worldwide in children. Otorrhea following tube insertion can be challenging to manage and lead to poor quality of life for the patient. Reported rates vary widely from 4% to 70%. Predisposing factors include patient age, eustachian tube function, immune function, indication for tube placement, and extrinsic factors such as water exposure. Earlier research has explored methods for antiseptic preparation of the external ear, postoperative oral antibiotics, tympanostomy tubes coated with antibiotics, and topical saline application to reduce otorrhea rates. Many of the studies assessing topical antibiotics' benefits are heterogeneous. Some studies are randomized by ear, while others are by the patient; some include topical antibiotics alone and others in combination with topical steroids, and there are varying treatment durations. This review investigates whether administering a single dose of topical antibiotics to children with middle ear effusion during tympanostomy tube placement reduces postoperative otorrhea, a practice that is not currently standard. A Cochrane review published in 2013 assessed a wide range of interventions for preventing otorrhea following tympanostomy tube insertion [1]. They performed a meta-analysis of three studies and found that a single application of either ciprofloxacin or gentamicin at the time of surgery significantly reduced the prevalence of postoperative otorrhoea from 13% in 268 ears with no treatment to 6% in 267 ears (RR 0.47, 95% CI 0.27–0.83, NNTB 14.9). These studies included patients with no effusion and those with effusion at the time of tube insertion. One study included in the meta-analysis by Scott and Strunk [2] randomized 53 children. Among the study participants, 62% had tubes placed for chronic otitis media with effusion (COME) and 37% for recurrent acute otitis media (RAOM); 44% had a dry middle ear, 18% had serous effusion, and 38% had mucoid effusion—purulent effusions were excluded. All patients who developed postoperative otorrhoea had mucoid effusion at the time of surgery; this correlation was statistically significant (p < 0.001). Another study in this meta-analysis performed by Nawasreh and Al-Wedyan [3] randomized 150 children by ear to receive no drops, a single dose of ciprofloxacin 0.3% drops intraoperatively, or intraoperative drops followed by 5 days of topical treatment. A total of 292 tubes were inserted for COME and RAOM in the study; 14.2% had a dry middle ear, 35.6% contained serous effusion, 48.2% had mucoid effusion, and 2% were purulent. They found a reduced rate of otorrhoea in the mucoid effusion group from 32.4% in those who received no treatment to 13.1% in those who received a single dose of ciprofloxacin and to 5.9% in those who received 5 days of treatment (p = 0.02). This Cochrane review also evaluated saline irrigation of the middle ear. It included two arms from a study: middle-ear irrigation of 1 mL of saline until the middle ears were cleared of “sticky effusion” versus no irrigation after tube insertion [1]. Postoperative otorrhoea was reduced from 30% in controls to 16% in irrigated ears (RR 0.52, CI 0.27–1.00, NNTB = 7). They concluded that if a surgeon has a high rate of postoperative otorrhea, then saline irrigation or topical antibiotics at the time of tube insertion would significantly reduce the rate. They did not define what was considered a high rate. If antibiotics were chosen, they recommend a single application at the time of surgery rather than a prolonged course to minimize cost and potential ototoxicity. More recently, a randomized control trial (RCT) performed by Wang et al. [4] randomized children into one of three arms: single intraoperative application of ciprofloxacin drops, extended 5-day postoperative application, and no drops. Patients were then evaluated at 6 weeks by blind assessors. Children treated with topical antibiotics received ciprofloxacin 0.3% (Ciloxan), either five drops into each ear following tympanostomy tube insertion intraoperatively or five drops intraoperatively and twice daily application for 5 days. Tragal pressure was applied following the application of ciprofloxacin, and cotton wool was placed to ensure patient blinding. Primary endpoints were tympanostomy tube otorrhea and blockage. Researchers randomized 296 children, and 512 ears were included. Children with purulent effusion at the time of myringotomy were excluded from the study. The most common indication for tympanostomy tube was COME in 66%, with the remainder being performed for RAOM. The middle ear was dry in 41.4%, mucoid effusion was found in 38.3%, and serous effusion in 20.3%. They found a 9% overall rate of otorrhea at 6 weeks. Patients who received intraoperative antibiotics were less likely to develop otorrhea than the control group (p = 0.006), with an absolute risk reduction of 8.89%. There was no statistically significant difference in otorrhea rates between the control and extended 5-day application group. They did not perform a subgroup analysis to assess whether children with effusion at the time of surgery had higher rates of otorrhea than those with a dry middle ear, but overall, the majority of ears included had effusion (58.6%). The National Institute for Health and Care Excellence (NICE) guideline for “Otitis media with effusion in under 12s” includes a recommendation for surgeons to “Consider a single dose of ciprofloxacin ear drops given intraoperatively during grommet insertion to prevent otorrhea and tube blockage.” [5] Their rationale was based on moderate-quality evidence, including the RCT performed by Wang et al., that ciprofloxacin drops had benefits in terms of reduction of postoperative otorrhea. They also acknowledged that otorrhea can be painful for children and difficult for families to manage. It is also unlikely that a single dose of topical ciprofloxacin would impact antibiotic resistance. To reduce the rate of postoperative otorrhea, a single dose of topical antibiotic should be administered at the time of tympanostomy tube insertion. Level of evidence: 1. The authors have nothing to report. The authors declare no conflicts of interest.