OTO-201 for the Treatment of Acute Otitis Externa: Results from a Phase 3 Randomized Clinical Study.

Objectives: OTO-201 is a ciprofloxacin otic suspension previously approved by the US Food and Drug Administration to treat children with bilateral otitis media with effusion requiring tympanostomy tube placement. In this phase 3, double-blind, randomized, prospective, sham-controlled, multicenter study, a single dose of OTO-201 was administered to the external auditory canal in subjects with unilateral or bilateral acute otitis externa.

Methods: Two hundred sixty-two subjects, 3 to 83 years of age, were randomized, and 260 subjects were included in the intent-to-treat analysis population: OTO-201 (0.

Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials.

Importance: Otorrhea after tympanostomy tube placement (TTP) in children is common. Although not approved by the US Food and Drug Administration, antibiotic ear drops are routinely used intraoperatively and prescribed for multidose, multiday postoperative administration by caregivers.

Objective: To investigate the safety and efficacy of a single-dose intratympanic, intraoperative, thermosensitive, otic suspension of ciprofloxacin (OTO-201) in children requiring TTP.

Randomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery.

Objective: This exploratory clinical trial evaluated the safety and clinical activity of a novel, sustained-exposure formulation of ciprofloxacin microparticulates in poloxamer (OTO-201) administered during tympanostomy tube placement in children.

Methods: Double-blind, randomized, prospective, placebo- and sham-controlled, multicenter Phase 1b trial in children (6 months to 12 years) with bilateral middle ear effusion requiring tympanostomy tube placement. Patients were randomized to intraoperative OTO-201 (4 mg or 12 mg), placebo, or sham (2:1:1 ratio).

Facial cutaneous necrosis associated with suspected levamisole toxicity from tainted cocaine abuse.

Objective: This study aimed to illustrate the otorhinolaryngologic manifestations of levamisole toxicity and illuminate the features of this diagnosis.

Methods: We describe a case of a known cocaine abuser with suspected levamisole toxicity who developed cutaneous necrosis of the cheeks, earlobes, nose, upper and lower lip, and the midline hard palate. We also review the existing clinical literature about this emerging phenomenon.

Can plastic tracheotomy tubes harm baby boys?

Pediatric tracheotomy tubes are often made from polyvinyl chloride (PVC). Di(2-ethylhexyl) phthalate (DEHP) is a common additive to PVC to increase tracheotomy tube flexibility and strength. Unfortunately, DEHP is a reproductive toxicant that alters the male reproductive system in animals, in vitro tests, and limited human data.

Does an oral appliance reduce palatal flutter and tongue base snoring?

Objectives: Oral appliances are designed to treat snoring and sleep apnea by advancing the mandible and tongue. We test the hypothesis that an oral appliance affects palatal snoring as well as tongue base obstruction.

Methods: Prospective observational cohort study.

Acoustical analysis of pediatric snoring: what can we learn?

Objective: Evaluate a database of pediatric patients who underwent snoring acoustical analysis for associations between snoring measurements, demographics, and obstructive sleep apnea/hypopnea syndrome (OSAHS) severity.

Study Design And Setting: A database of pediatric patients who underwent home testing with a polysomnogram device (SNAP Test, Glenview, IL) that includes acoustical snoring analysis was reviewed.

Results: Four hundred fifty-six patients were included (mean age, 6.

Validations of a portable home sleep study with twelve-lead polysomnography: comparisons and insights into a variable gold standard.

Objectives: Accurate and timely diagnosis for patients with obstructive sleep apnea (OSA) is imperative. Unfortunately, growing interest in this diagnosis has resulted in increased requests and waiting times for polysomnography (PSG), as well as a potential delay in diagnosis and treatment. This study evaluated the accuracy and viability of utilizing SNAP (SNAP Laboratories, LLC, Wheeling, Illinois), a portable home sleep test, as an alternative to traditional PSG in diagnosing OSA.

Does obstructive sleep apnea affect aerobic fitness?

Objectives: We sought to determine whether patients with obstructive sleep apnea (OSA) had an objective change in aerobic fitness during cycle ergometry compared to a normal population. The most accurate test of aerobic fitness is measurement of maximum oxygen consumption (VO2max) with cycle ergometry.

Methods: We performed a retrospective cohort analysis (247 patients with OSA) of VO2max from annual cycle ergometry tests compared to a large control group (normative data from 1.

Pediatric functional endoscopic sinus surgery: frequently asked questions.

Pediatric endoscopic sinus surgery is a controversial procedure that has evolved considerably over the past 2 decades. We present a current review of the literature regarding the treatment of children with refractory sinusitis with a focus on the use of endoscopic sinus surgery. Preoperative evaluation, surgical technique, postoperative care, and unusual applications are discussed.

Acoustical analysis of snoring: can the probability of success be predicted?

Purpose: Palatal flutter snoring is the most common form of snoring. However, other types of snoring do exist. Does identifying palatal snoring beforehand translate into improved subjective treatment success with palatal stiffening procedures?

Methods: Fifty-three patients presenting with snoring were evaluated with a commercially available device.

Submucosal minimally invasive lingual excision: an effective, novel surgery for pediatric tongue base reduction.

Objectives: The aim of this study was to develop an effective single intraoral, minimally invasive technique to reduce the enlarged tongue base in children with obstructive macroglossia.

Methods: We present the anatomic dissection of fresh cadavers and a representative case series of children who underwent submucosal minimally invasive lingual excision (SMILE) with a plasma-mediated radiofrequency device (coblation) under intraoral ultrasonic and endoscopic guidance. Multiple anatomic dissections determined the relative location of the hypoglossal nerve and lingual neurovascular bundle in relation to removable tongue base musculature.

Two babies, one heart, and no airway.

The medical literature on conjoined twins is replete with descriptions of the complexity of surgical separations. However, airway management, although quite challenging, is neglected in literature. We present experience with conjoined twins united anteriorly at the thorax and abdomen sharing one six-chambered heart.

Total nasopharyngeal stenosis: treatment with laser excision, nasopharyngeal obturators, and topical mitomycin-c.

Objective: Severe nasopharyngeal stenosis after uvulopalatopharyngoplasty (UPPP) is a dreaded complication. Very little has been written about successful treatment because attempts at correction frequently fail. Severe stenosis of the nasopharynx drastically worsens speech, swallowing, and obstructive sleep apnea (OSA).

Potential applications of the da Vinci minimally invasive surgical robotic system in otolaryngology.

Anatomic constraints and instrumentation design characteristics have limited the exploitation of endoscopic surgery in otolaryngology. The move toward less invasive and less morbid procedures has paved the way for the development and application of robotic and computer-assisted systems in surgery. Surgical robotics allows for the use of new instrumentation in our field.

Does increased electrocautery during adenoidectomy lead to neck pain?

Objectives: The objective was to assess the impact of electrocautery on complications in adenoidectomy. We sought to quantify cautery-related temperature changes in prevertebral fascia that may occur during the procedure, retrospectively evaluate the incidence of cautery-related complications, and prospectively assess the role of cautery in postoperative neck pain.

Methods: Three consecutive related trials were performed.

Neonatal suppurative submandibular sialadenitis: case report and literature review.

Acute submandibular sialadenitis is rare in the neonatal period and appears to be associated with prematurity. We describe a case of a premature neonate who developed suppurative submandibular sialadenitis from a hypervirulent strain of methicillin-resistant Staphylococcus aureus. The etiology, diagnosis, and treatment of this condition are discussed.

Seldinger-assisted videotelescopic intubation (SAVI): a common sense approach to the difficult pediatric airway.

Objectives: To describe the Seldinger-assisted videotelescopic intubation (SAVI) technique, a complementary method for aiding in difficult pediatric intubations that uses common equipment available to the practicing otolaryngologist.

Study Design: Technique description.

Methods: Detailed description of technique for use of a pediatric laryngoscope with video-assisted endotracheal tube (ETT) covered rigid tracheoscopy controlled intubation in difficult pediatric airways.

West Nile virus: a primer for the otolaryngologist.

Background: Since recognition in the United States with a 1999 New York City epidemic, West Nile virus has enduringly migrated westward, leaving few states unaffected. Infection rates are rising at an alarming rate, doubling every year since introduction, with more than 9800 cases in 2003 alone and more than 260 deaths. Patients may present with myriad symptoms including a maculopapular rash that affects the face and trunk and diffuse lymphadenopathy, both of which may result in the initial consultation of the otolaryngologist.

Endoscopic surgery of the anterior skull base.

Objectives/hypothesis: Traditional surgical approaches to the anterior skull base often involve craniotomy, facial incisions, disruption of skeletal framework, tracheotomy, and an extended hospital stay. As experience with endoscopic sinus surgery has grown, the techniques and equipment have been found to be adaptable to treatment of lesions of the anterior and central skull base. A minimally invasive endoscopic approach theoretically offers the advantages of avoiding facial incisions, osteotomies, and tracheotomy; surgery should be less painful, recovery quicker, and hospital stays should be shorter.