Assessing National Trends and Perceived Safety of Off-Label Ciprofloxacin-Dexamethasone Use by Pediatric Otolaryngologists.

OBJECTIVES: Off-label use of Ciprodex® (ciprofloxacin-dexamethasone: CPD), an antibiotic-steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off-label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility. METHODS: 15-item cross-sectional survey was distributed to American Society of Pediatric Otolaryngology members from January-April 2022. Univariate analyses were performed to compare responses for users of off-label CPD versus non-users. Ease of access was compared across geographies and practice types using multivariate logistic regressions. RESULTS: Of the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off-label CPD. Most common indications for off-label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63-1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55-682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01-0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002-0.33, p = 0.009) compared to academic free-standing children's hospitals. Two-thirds of respondents reported feeling "Very Comfortable" with the safety profile of off-label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off-label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off-label use. CONCLUSIONS: Our findings (26.6% response rate) suggest that off-label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off-label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off-label CPD and to improve its accessibility. LEVEL OF EVIDENCE: V Laryngoscope, 134:2922-2930, 2024.

Comparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy.

OBJECTIVE(S): Coblation, or radiofrequency ablation, and pulsed-electron avalanche knife (PEAK) plasmablade are newer approaches for tonsillectomy that reduce exposure to thermal heat. This study aims to describe and compare adverse events related to these devices for tonsillectomy. STUDY DESIGN: Retrospective cross-sectional study. SETTING: The US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried for reports involving coblation devices and the PEAK plasmablade from 2011 to 2021. Data were extracted from reports pertaining to tonsillectomy with and without adenoidectomy. RESULTS: There were 331 reported adverse events for coblation and 207 for the plasmablade. For coblation, 53 (16.0 %) of these involved patients and 278 (84.0 %) were device malfunctions. Similarly for the plasmablade, 22 (10.6 %) involved patients and 185 (89.4 %) were device malfunctions. The most frequent patient-related adverse event was burn injury, which was significantly more common with the plasmablade compared to coblation (77.3 % vs. 50.9 %, respectively, p = 0.042). For both the coblator and plasmablade, the most common device malfunction was intraoperative tip or wire damage (16.9 % vs. 27.0 %, respectively, p = 0.010). The Plasmablade tip caught fire in five reports (2.7 %) with one causing burn injury. CONCLUSIONS: While coblation devices and the plasmablade have demonstrated utility in tonsillectomy with or without adenoidectomy, they are associated with adverse events. Plasmablade use may require greater caution for intraoperative fires and patient burn injuries compared to coblation use. Interventions to improve physician comfort with these devices may help reduce adverse events and inform preoperative discussions with patients.

Assessing the safety of continued perioperative antithrombotic therapy in endoscopic airway surgery for laryngotracheal stenosis.

PURPOSE: Given the increasing utilization of endoscopic surgery, particularly for airway stenosis management in the era of COVID-19 due to prolonged intubation, it is important to examine whether continuing antithrombotic therapy perioperatively influences bleeding complications. We examined the impact of perioperative antithrombotic use on postoperative bleeding complications following endoscopic airway surgery for laryngotracheal stenosis. MATERIALS AND METHODS: Retrospective study from January 2016 to December 2021 of cases of patients ≥18 years who underwent endoscopic airway surgery for posterior glottic, subglottic, and tracheal stenosis at a single institution. Cases were excluded if they were an open airway surgery. The primary outcome was the occurrence of postoperative bleeding complications across cases of patients naive to and on baseline antithrombotic therapy, and those with preoperative continuation versus cessation of antithrombotic therapy. RESULTS: 258 cases across 96 patients met inclusion criteria. Of these 258 cases, 43.4 % (n = 112) were performed for patients on baseline antithrombotic therapy and 56.6 % (n = 146) for those not on antithrombotic therapy. Likelihood of perioperative continuation of apixaban was 0.052 (odds ratio, 95 % Confidence Interval: 0.002-0.330, p < 0.001). Likelihood of perioperative continuation of aspirin was 9.87 (odds ratio, 95 % Confidence Interval: 2.32-43.0, p < 0.001). Two instances of postoperative bleeding were found: both in patients who were on aspirin without perioperative cessation for COVID-related coagulopathy. CONCLUSIONS: Our findings suggest that perioperative continuation of aspirin is relatively safe in the setting of endoscopic surgery for airway stenosis management. Prospective investigations to increase understanding of perioperative antithrombotics for COVID-related coagulopathy are warranted.