Tympanostomy tube placement in awake, unrestrained pediatric patients: A prospective, multicenter study.

OBJECTIVES: Tympanostomy tube (tube) placement is the most common pediatric otolaryngologic surgery in the United States. Most surgeries are performed in an operating-room setting under general anesthesia due to the lack of tolerable and reliable local anesthesia methods suitable for pediatric patients, and concerns regarding myringotomy procedures in a mobile child. This study evaluated the safety and efficacy of an iontophoresis system (IPS) to achieve local anesthesia in combination with a tube delivery system (TDS) for tube placement in pediatric patients in an office setting. METHODS: A prospective, single-arm study was conducted at 9 otolaryngology sites in the United States. Participants included pediatric patients aged 6 months to less than 22 years requiring tube placement. Patients were prepared for the procedure using behavioral support techniques and tube placement was attempted under local anesthesia using the IPS in conjunction with the TDS. No physical restraints were allowed and no anxiolytics, analgesics, or sedatives were permitted. Safety was assessed through the occurrence of adverse events and success rates for tube placement under local anesthesia were determined. Tolerability of the procedure was evaluated using the 5-point Wong-Baker FACES Pain Rating Scale and parental satisfaction was assessed using a postoperative survey. RESULTS: Seventy patients (127 ears) were enrolled in the study [mean (SD) age=7.0 (3.9) years]. No serious adverse events occurred in the 70 enrolled patients. Tube placement using the TDS was successful in 96.6% (114/118) of attempted ears. A single TDS was required in 105 ears, while more than 1 device was required in 9 ears. Of the 70 patients enrolled in study, 63 (90.0%) successfully received tubes in all indicated ears during their in-office visit. The mean (SD) change in pain score from pre-anesthesia to post-surgery was +0.9 (1.8). Favorable ratings for overall satisfaction with the in-office procedure were obtained from 96.9% (63/65) of respondents. Tube retention at 2 weeks was 99.1%. As only 15 patients were enrolled who were 3 years old or younger, the ability to generalize these results to younger patients is limited. CONCLUSIONS: In this study, use of the IPS and TDS technologies enabled safe, reliable, and tolerable placement of tubes in awake, unrestrained pediatric patients.

Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study.

BACKGROUND: Treatment options for chronic rhinosinusitis with recurrent polyposis (CRSwNP) after endoscopic sinus surgery (ESS) are limited, and include frequent use of systemic steroids and revision surgery. A bioabsorbable, steroid-eluting implant was studied for its ability to dilate sinuses obstructed by polyps and provide localized, controlled steroid delivery to reestablish sinus patency. This study assessed the initial feasibility, safety, and efficacy of steroid-eluting implants placed in the office setting in patients who were candidates for revision ESS. METHODS: Prospective, multicenter study enrolling 12 patients who had prior ESS but experienced recurrent polyposis refractory to medical therapy. Implants were placed bilaterally under topical anesthesia in-office. Follow-up through 6 months included endoscopic grading, patient-reported outcomes (22-item Sino-Nasal Outcomes Test [SNOT-22]) and need for revision ESS. RESULTS: Implants were successfully inserted in 21 of 24 (88%) ethmoid sinuses, resulting in 11 evaluable patients. No serious adverse events occurred. Within 1 month, mean bilateral polyp grade was reduced from 4.5 at baseline to 2.3 (p = 0.008) and sustained through 6 months (2.33; p = 0.008). Mean SNOT-22 score was significantly improved from 2.19 at baseline to 0.90 within 1 month (p = 0.001) and sustained to 6 months (1.03; p = 0.012). Sixty-four percent of patients were no longer revision ESS candidates at 6 months. CONCLUSION: The study provided initial clinical evidence of the feasibility, safety, and efficacy of in-office steroid-eluting implant placement in CRS patients with recurrent polyposis after ESS. Although further studies are needed, the results suggest this therapy may provide a safe and effective, office-based option for the treatment of obstructive polyposis.

Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis.

BACKGROUND: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent interventions. A bioabsorbable, steroid-releasing sinus implant has been studied in 2 prospective, randomized clinical trials for its ability to preserve sinus patency and reduce medical and surgical interventions after ESS in patients with CRS. The objective of this study was to perform a meta-analysis of the efficacy results from the 2 trials. METHODS: The 2 prospective, randomized, double-blinded, multicenter trials enrolled a total of 143 patients utilizing an intrapatient control design. Postoperative day 30 videos were obtained for each patient, randomly ordered, and presented to an independent panel of 3 otolaryngologists for grading of efficacy endpoints. The need for postoperative interventions, formation of polyposis, and adhesions were assessed. Results from the 2 studies were then pooled. RESULTS: Implants were successfully placed in all 286 ethmoid sinuses. According to the grading done by the panel, drug-releasing implants reduced postoperative interventions by 35% (p = 0.0008), lysis of adhesions by 51% (p = 0.0016), and oral steroid need by 40% (p = 0.0023), compared to controls. The relative reduction in frank polyposis was 46% (p < 0.0001). CONCLUSION: Early postoperative healing is a predictor of longer-term success after sinus surgery. Evaluation of postoperative outcomes by a blinded independent panel demonstrates that steroid-releasing implants that provide a sustained release of corticosteroid improve surgical outcomes by reducing frank polyp formation, sinus adhesions, and middle turbinate lateralization. Steroid-releasing implants reduce the need for surgical intervention, and the need for oral steroid treatment.

Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent.

BACKGROUND: Inflammation/polyp recurrence, adhesions, and middle turbinate lateralization are causes of suboptimal outcomes following sinus surgery and lead to increased rates of revision. A bioabsorbable, drug-eluting stent was evaluated for its ability to preserve sinus patency by providing controlled steroid delivery to the sinus mucosa. The study objective was to assess safety and efficacy of a steroid-eluting sinus stent when used following functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis (CRS). METHODS: Prospective, multicenter, randomized, double-blind clinical trial, enrolling 43 patients in 2 groups. One group (n = 38) used an intrapatient control design comparing drug-eluting to non-drug-eluting stents. The other group (n = 5) received bilateral drug-eluting stents to assess systemic safety. Endoscopic follow-up was performed for 60 days. Efficacy endpoints included assessment of inflammation, polyp formation, adhesions, and middle turbinate position. RESULTS: Stents were successfully deployed in all 86 sinuses. Compared to the control stent, the drug-eluting stent provided statistically significant reduction in inflammation at days 21 to 45 (p < 0.003), frequency of polyp formation (p = 0.0391), and frequency of significant adhesion (p = 0.0313). Reduced frequency of middle turbinate lateralization was also apparent though not statistically significant. No device-related adverse events occurred. Eluted steroid was unquantifiable systemically and there was no evidence of adrenal cortical suppression. CONCLUSION: This study demonstrates the safety and efficacy of a novel bioabsorbable, steroid-eluting stent for use in CRS patients. The steroid-eluting stent is effective in improving wound healing by preserving sinus patency, reducing inflammation, and minimizing adhesions via controlled local steroid delivery without measurable systemic exposure.

Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes.

OBJECTIVE: Comparison of topical ciprofloxacin/dexamethasone otic suspension (CIP/DEX) to ofloxacin otic solution (OFL) for treatment of granulation tissue in children with AOMT. STUDY DESIGN: 599 children aged >/=6 months to 12 years with AOMT of up to 3 weeks' duration were enrolled. Patients received either CIP/DEX 4 drops twice daily for 7 days or OFL 5 drops twice daily for 10 days. Granulation tissue severity was graded at clinic visits on days 1, 3, 11, and 18. RESULTS: Granulation tissue was present in 90 of 599 AOMT patients (15.0%) at baseline. CIP/DEX treatment was superior to OFL for reduction of granulation tissue at the day 11 visit (81.3% compared with 56.1%, P = 0.0067) and the day 18 visit (91.7% compared with 73.2%, P = 0.0223). Both topical otic preparations are safe and well tolerated in pediatric patients. CONCLUSION: CIP/DEX was superior to OFL in the treatment of granulation tissue in children with AOMT.