Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System.

OBJECTIVE: Evaluate 2-year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in-office. STUDY DESIGN: Prospective, single-arm. SETTING: Eighteen otolaryngology practices. METHODS: Children age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead-In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated. RESULTS: Tubes were placed in-office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In-Office cohorts were 15.82 (95% confidence interval [CI]: 15.41-19.05) and 16.79 (95% CI: 16.16-17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow-up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes. CONCLUSION: In-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet-type tubes and complication rates consistent with traditional tube placement in the OR.

Nasal Obstruction in the Infant.

Neonatal nasal obstruction is common in both the hospital and clinic settings. Causes can range from rhinitis to congenital masses, with a wide variety of congenital nasal masses described. A complete history and physical examination are necessary for correct diagnosis and management. Arhinia and bilateral choanal atresia will present with complete obstruction leading to forced mouth breathing. Partial obstruction will require assessment of nasal patency with possible nasal endoscopy and imaging. Medical and surgical options for treatment are discussed.

In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.

OBJECTIVES/HYPOTHESIS: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting. STUDY DESIGN: Prospective individual cohort study. METHODS: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces Pain Scale-Revised (FPS-R) instrument, which ranges from 0 (no pain) to 10 (very much pain). RESULTS: Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures. CONCLUSIONS: In-office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. LEVEL OF EVIDENCE: 2b Laryngoscope, 130:S1-S9, 2020.

Advanced practice providers and children's hospital-based pediatric otolarynology practices.

INTRODUCTION: Advanced practice providers (APPs), including nurse practitioners and physician assistants, have been deployed in children's hospital-based academic pediatric otolaryngology practices for many years. However, this relationship in terms of prevalence, roles, financial consequences and satisfaction has not been examined. The objective of this study is to explore how APPs impact healthcare delivery in this setting. METHODS: Pediatric otolaryngology chiefs of all academic children's hospitals in the US were electronically surveyed about the ways APPs intersected clinically and financially in their respective practice. RESULTS: A total of 29 of 36 children's hospital-based pediatric otolaryngology practices completed the survey, of which 26 practices (90%) utilized APP. There were large variances within the APP practice cohort in faculty size (mean/median/range = 9.4/8.5/3-29); annual patient visits (mean/median = 18,373/17,600); number of practice site (mean/median/range = 4.3/4/2-9) and number of outpatient APP (mean/median/range = 6.3/5/1-30). No factors (faculty size, annual visits and number of practice sites) differentiated between the APP and non-APP practices. Among APP practices, significant correlation (p<.00001) was observed between size of APP cohort to faculty size and annual visits. 69% of the practices did not differentiate job functions of nurse practitioners and physician assistants. 85% of the practices utilized APPs in all practice sites and 19% utilized APPs in the operating room. 77% of APPs billed independently and 46% had on-site supervision. The most prevalent APP salary bracket based on 0-5, 6-10 and > 11 years of tenure were $76-100K (65%), $100-150K (77%) and $100-150K (86%), respectively. In 46% of the practices, APPs were able to generate enough revenue to cover more than 75% of their salary and 23% of practices generated a profit. 81% of the chiefs ranked the effectiveness of APPs as high (4 and 5) on a 5-point Likert scale. DISCUSSION: The majority of academic pediatric otolaryngology practices employed APPs. Despite the diversity seen in practice complexity, APP functionality and financial impact, most found the APP model to be beneficial in improving patient care, patient access and faculty productivity.

Basic choking education to improve parental knowledge.

OBJECTIVE: To evaluate the effect of an educational intervention on parental knowledge of choking hazards and prevention. METHODS: A quasi experimental study was performed utilizing an internet based educational video intervention for parents with a child 6 months to 4 years old presenting to a Pediatric Otolaryngology clinic at a Level 1 pediatric hospital. Following the clinic visit, participants were sent a choking video (intervention) or general safety video (control) with a pretest and posttest knowledge survey (via email). An additional posttest knowledge survey was sent 30 days later as a surrogate measure for knowledge retained over time. Frequencies, chi square test, Independent t-test and McNemar's test were used for statistical analyses. RESULTS: 202 participants viewed the video and completed both the pretest and immediate posttest knowledge survey. Average change in total knowledge scores from the pretest to immediate posttest was statistically significant between the intervention (µâ€¯= 1.88, σ = 1.20) and control group (µâ€¯= 0.14, σ = 1.05); t (200) = -10.99, P < .001. This finding was consistent when assessing change from the pretest to 30 day posttest between the intervention (µâ€¯= 1.41, σ = 1.32) and control group (µâ€¯= 0.17, σ = 1.41); t (118) = -4.95, P < .001. A majority of the knowledge questions (5 of 7) showed a significant change in score from the pretest to immediate posttest (P = .001-.027). Additional analyses revealed accuracy on 4 of 7 knowledge questions significantly changed from the pretest to 30 day later posttest (P < .001- .002). CONCLUSION: The brief educational video overall improved parental knowledge of choking hazards and prevention immediately after the video and 30 days later. Importantly, improved parental knowledge may decrease rates of choking among children.

Otologic Pathology and Hearing Loss in Children with Down Syndrome, 6 - 18 Years Old.

Ihis article is a retrospective, sin- gle-center, single-surgeon review of all patients with Down syndrome (Trisomy 21) seen at a free- standing children's hospital between January 2000 and December 2011. The aim was to assess for un- recognized otologic pathology and hearing impair- ment in all new patients between six and 18 years old. Two-hundred-nine patients were seen during the study time frame. Fifty-one patients underwent ear tube surgery with eight patients undergoing surgery for at least three sets of ear tubes. Four patients underwent more advanced ear surgeries for perforation, severe retraction with conductive hearing loss, or acquired cholesteatoma.'Ihere were no cervical subluxations or dislocations periopera- tively. 'Ihirty-six of 47 patients between six and 18 years old had some degree of hearing impairment. 'he success rate of otologic surgery is similar to the non-Down syndrome population. A more compre- hensive database should be developed to ascertain the incidence ofhearingimpairmentin school-aged children with Down syndrome.

Disorders of the neonatal nasal cavity: Fundamentals for practice.

Neonatal nasal obstruction is a well-known clinical entity. Fortunately, it is rarely life-threatening and usually resolves with conservative management. As with most conditions, a systematic history and thorough physical examination are crucial for correct diagnosis and management. The initial diagnosis may be elusive and require either serial or more in-depth evaluations. Occasionally, examination may reveal structural abnormalities necessitating surgical intervention. Fortunately most of these abnormalities are amenable to surgery; however, a select few are notoriously difficult to treat.

Time out for surgeons: when is the attending surgeon too tired?

Pediatric surgical subspecialty workforce shortages are here to stay without any expected solution for the short-term. Individual surgeons, hospital administrators, risk management and patient-safety teams need to recognize that patient safety must take precedence over clinical productivity and financial "bottom lines." Pushing attending surgeon work hours beyond the limits of exhaustion impairs patient safety. Just as resident surgeon work hours have been appropriately curtailed in the name of patient safety, so must attending surgeon work hours. This issue needs to be addressed by hospital patient safety committees, professional societies, and by state and national regulating authorities.

Evaluation of pediatric sensorineural hearing loss: a survey of pediatric otolaryngologists.

OBJECTIVES: We sought to determine the trends in the evaluation of pediatric patients with sensorineural hearing loss (SNHL) and to determine evaluation patterns based on respondents' demographic data. METHODS: All members of the American Society of Pediatric Otolaryngology were invited to voluntarily and anonymously complete an online survey. The survey was available from September 2009 to January 2010 and addressed demographic data and tests obtained in evaluating new pediatric patients with SNHL at different age points and with different degrees of hearing loss. RESULTS: The response rate was 22.9% (79 of 345). For all ages and all types of SNHL, the most common consultations were genetics (26% to 76%) and ophthalmology (31% to 66%) consultations. Computed tomography of the temporal bones (49% to 66%), genetic testing (25% to 68%), and electrocardiography (13% to 43%) were the most commonly performed tests. Although there was no consistent difference in practice patterns by gender or years of practice, there were differences in the use of thyroid function tests, TORCH titers, and autoimmune studies by hospital affiliation. CONCLUSIONS: Type of SNHL and age are factors in the evaluation of pediatric patients with SNHL. Additionally, evaluation patterns differ according to region and hospital affiliation. The results of this study may provide guidance for otolaryngologists in making information-based and cost-effective evaluations.

A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion.

We conducted a prospective, randomized, placebo-controlled, double-blind study to determine if the leukotriene inhibitor montelukast is effective in eliminating persistent middle ear drainage in patients with otitis media with effusion (OME). Our study population was made up of patients aged 2 to 6 years who had had confirmed OME in one or both ears for at least 2 months. Patients were randomized to receive either placebo or 4 mg of montelukast daily for 1 month. The main outcome measure was clearance of middle ear effusion as demonstrated by otoscopy and tympanometry 1 month after the initiation of treatment. Our goal was to recruit 120 patients; however, an interim analysis was conducted after 38 patients had completed their regimen (19 patients in each group) when it became apparent that montelukast was not having any effect in clearing the effusions. Indeed, the OME had cleared in only 3 montelukast patients (15.8%) and 4 controls (21.1%); the difference was not statistically significant (p > 0.90). Based on this early trend, the study was terminated at this point. We conclude that montelukast appears to be no more effective than placebo in eliminating persistent middle ear effusion.

Act to keep patients safe: device-related adverse event reporting.

Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events.

Auditory function after a prolonged course of ciprofloxacin-dexamethasone otic suspension in a murine model.

OBJECTIVE: To test for ototoxicity after prolonged ototopical fluoroquinolone use in the middle ear space using a murine model. DESIGN: Nonrandomized controlled trial. SUBJECTS: Twelve CBA/J mice. INTERVENTIONS: The mice received daily intratympanic injections of ciprofloxacin-dexamethasone otic suspension for 21 days. The contralateral ear received daily intratympanic injections of sterile isotonic sodium chloride solution (saline) as a control. MAIN OUTCOME MEASURES: Click-evoked auditory brainstem response (ABR) thresholds were obtained before injection and 10 days and 3 months after injection. RESULTS: Mean (SEM) preinjection ABR thresholds were 47.17 (2.74) dB peak equivalent sound pressure level (peSPL) in ciprofloxacin-dexamethasone-treated ears and 45.08 (1.56) dB peSPL in saline-treated ears (P = .38). Mean (SEM) postinjection ABR thresholds in ciprofloxacin-dexamethasone-treated ears were 44.25 (1.25) dB peSPL after 10 days and 43.00 (1.51) dB peSPL after 3 months. Mean (SEM) postinjection ABR thresholds in saline-treated ears were 48.00 (1.51) dB peSPL after 10 days and 45.92 (1.79) dB peSPL after 3 months. There were no significant differences in ABR thresholds for ciprofloxacin-dexamethasone-treated ears (P = .29, P = .10) or saline-treated ears (P = .07, P = .59). CONCLUSION: Ciprofloxacin-dexamethasone suspension did not cause either immediate or delayed ototoxicity after 21 days of intratympanic administration in the CBA/J mouse model.

Transnasal endoscopic repair of choanal atresia: why stent?

OBJECTIVE: To analyze the outcome of transnasal endoscopic repair of choanal atresia in children without stenting. DESIGN: Retrospective review. SETTING: Academic pediatric referral center. PATIENTS: Thirteen children ages 2 days to 13 years old (mean 45 months) who presented with unilateral (8) or bilateral (5) choanal atresia and underwent transnasal endoscopic surgery between January 1997 and May 2002. No stents were used. All patients received combinations of oral steroids, topical nasal steroids, and oral antibiotics. Patency was defined as less than 50% restenosis. RESULTS: The 4 patients who underwent office serial examination alone after surgery remained patent. Seven of the 9 patients who underwent reexamination under general anesthesia had varying amounts of emerging granulation tissue or minor synechia formation that resolved with microdebrider excision. All serial office endoscopies demonstrated no restenoses. No office dilations were performed. There were no long-term complications. One patient (2 days old) who underwent tracheoesophageal fistula repair and bilateral choanal atresia repair on the same day required a blood transfusion. Both patients with tracheostomies were decannulated. CONCLUSIONS: Transnasal endoscopic repair of choanal atresia, both unilateral and bilateral, is safe, and is effective without stenting. Postoperative failure of endoscopic approaches may be a result of prolonged mucosal trauma from stenting rather than any deficiency inherent in the surgical technique. Adjuctive therapy may not offer any advantage in promoting patency.

Minimizing Upper Lip and Incisor Teeth Paresthesias in Approaches to Transsphenoidal Surgery.

Currently popular transsphenoidal approaches to the pituitary include sublabial, external rhinoplasty, alotomy, and transnasal techniques. The conventional sublabial approach remains the workhorse method despite postoperative lip edema, potential difficulty for denture wearers, and troublesome persistent upper lip and incisor teeth numbness. We traced the courses of the nasopalatine, infraorbital, and anterior superior alveolar nerves in 41 cadaveric half-head dissections to determine the exact contribution to upper lip and incisor teeth innervation. We then conducted a retrospective patient survey of 25 sublabial, 28 external rhinoplasty, 23 alotomy, and 12 transnasal approaches to the hypophysis to assess the incidence of upper lip and incisor teeth paresthesias lasting longer than 1 month. We conclude that rhinoplastic techniques are superior to the sublabial approach in limiting upper lip and incisor teeth numbness without compromising neurosurgical exposure for hypophysectomy.