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Importance: Many treatments for clogged tympanostomy tubes (TTs) have been proposed, but none have met scientific rigor for safety and efficacy, including the popular empirical use of ototopical antibiotic drops. Dornase alfa, a recombinant molecule with the unique property of cleaving DNA, may be ideal in treating clogged TTs because both middle-ear effusion and the plug are abundant with DNA., Objective: To investigate the ototoxic effects of dornase alfa in a chinchilla model and its efficacy in a clinical trial in children with clogged TTs., Design, Setting, and Participants: The safety profiles of dornase alfa (full-strength and 1:10 strength) were evaluated in chinchilla middle ears using serial auditory brainstem response. The efficacy of ototopical dornase alfa (full-strength) was evaluated in children with clogged TTs in a prospective, single-blind randomized clinical trial. The animal study included 21 chinchillas and was conducted at Loma Linda University, Loma Linda, California, and the clinical trial was conducted at Children's Hospital Colorado, Aurora. A total of 40 children (50 ears with tubes) were enrolled., Interventions: In the animal study, chinchillas were assigned to 3 groups: controls (saline), full-strength dornase alfa, or 1:10 dornase alfa dilution. Children were randomly assigned to receive either topical dornase alfa or ofloxacin for clogged TT, 5 drops each ear twice a day for 7 days., Main Outcomes and Measures: Animal study: Auditory brainstem responses. Randomized trial of children participants: The primary outcome was patency of TT at day 14 assessed by otoscopy and tympanometry., Results: The chinchilla study showed similar auditory brainstem response degradation during a 6-hour period between the control (n = 5) and treatment groups (n = 21). In the clinical trial, a total of 40 clogged TTs (in 33 children, including 25 boys [76%]; mean age, 4.3 years; median [range] age, 3.4 [1.0-14.3] years) were analyzed. The number of unclogged TTs was higher in the dornase alfa group (13 [59%]) compared with the ofloxacin group (8 [44%]), with a difference of 15% (odds ratio, 1.8; 95% CI, 0.54-6.72)., Conclusions and Relevance: The chinchilla model suggests that dornase alfa is likely nonototoxic. The pilot clinical trial failed to show efficacy of dornase alfa to unclog TTs. With the difference seen between the treatment groups, a sample size estimate could be calculated for a future large-scale trial., Trial Registration: ClinicalTrials.gov identifier: NCT00419380.

Objective: To evaluate the safety and efficacy data on salivary gland injection botulinum toxin type A for the treatment of sialorrhea., Design and Setting: Retrospective cohort study in a tertiary academic children's hospital., Patients: A 10-year review (January 1, 2001, through December 31, 2010) of 69 children with sialorrhea who had undergone salivary gland injection of botulinum toxin type A., Interventions: Injection of botulinum toxin type A to the submandibular and parotid glands., Main Outcome Measures: Postinjection complications, supplemental treatments, and caregiver satisfaction., Results: A total of 69 children were included in the study (42 boys and 27 girls). The first injection was given at a mean age of 9.9 years with a mean follow-up of 3.1 years. Children underwent ultrasonography-guided 4-gland injection at a constant dosage range. The telephone survey response rate was 51%. Postinjection complications occurred in 19 patients (23 events)-14 (15 events) with minor and 5 (8 events) with major complications. Major complications included aspiration pneumonia (n = 3), severe dysphagia (n = 2), and loss of motor control of the head (n = 3), resulting in 5 hospitalizations and 2 nasogastric tube insertions. Complications were not associated with demographic or clinical factors except for a male preponderance (P = .05). Satisfaction scores were evenly distributed among respondents. Thirty-one children (45%) required supplemental treatments: medical treatment alone (n = 21), surgical treatment alone (n = 2), and combined medical and surgical treatment (n = 8)., Conclusions: Although our complication rate is within the published range, some of the major complications had significant morbidity. A subsequent surgical rate of 15% suggests the efficacy is less than universal. Thus, botulinum toxin type A injection for sialorrhea in children is a useful tool but has safety and efficacy limitations.

Objective: To determine the efficacy of intracapsular tonsillectomy using low-temperature plasma excision for improving the quality of the postoperative experience and for treating obstructive symptoms through 12 months postoperatively., Design: Prospective, randomized, controlled, single-blind study., Setting: Multiple private or institutional otolaryngology clinics., Patients: Fifty-five children (aged 3-12 years) with obstructive tonsillar hypertrophy., Intervention: Patients were randomly assigned and blinded to undergo either intracapsular tonsillectomy using low-temperature plasma excision (n = 27) or total tonsillectomy using conventional electrosurgery (n = 28)., Main Outcome Measures: Operative data, 14-day recovery variables, and obstructive symptoms were prospectively collected through 12 months., Results: During the first 14 days, significantly fewer children in the intracapsular group reported nausea (P = .01) or lost weight (P = .003). The intracapsular group had a significantly faster resolution of pain (P = .01), had an earlier return to a normal diet (P = .004), ceased taking pain medication sooner (P = .002), and returned to normal activity sooner (P = .04). Postoperatively, the intracapsular group had more residual tonsil tissue than the total tonsillectomy group (P = .002 for the 3- and 12-month visits). However, the incidence of recurring obstructive symptoms, pharyngitis, and antibiotic use was similar in both treatment groups during the 12 months., Conclusions: Postoperative morbidity normally associated with traditional (total) tonsillectomy was significantly reduced after intracapsular tonsillectomy using low-temperature plasma excision. The residual tonsillar tissue associated with this technique was of no clinical consequence.

Background: The Le Fort I maxillary osteotomy approach for skull base tumor removal in the pediatric age group has not been widely discussed in the literature except for sporadic case reports and limited case series., Objectives: To review our experience with the Le Fort I osteotomy and to propose that it be used as an alternative approach because of its many advantages for the removal of tumors of the central skull base and paranasal sinuses., Design: Case series., Setting: Tertiary academic center., Patients and Methods: A 5-year retrospective chart review of cases involving children who had undergone skull base tumor resection via the Le Fort I osteotomy approach., Interventions: Skull base tumor removal via the Le Fort I osteotomy approach., Main Outcome Measures: Tumor type, location, and size; intraoperative and postoperative complications; and residual tumor and/or tumor recurrence associated with the surgical approach., Results: Eleven patients (9 boys and 2 girls; mean age, 14.3 years) were identified through the chart review. The tumor types included 8 angiofibromas, 1 malignant fibrous histiocytoma, 1 giant cell tumor, and 1 cavernous hemangioma. All these lesions had extensive tumor growth into at least 1 of the following sites: pterygomaxillary space, sphenoidal sinus, and areas adjacent to the optic nerve, cavernous sinus, clivus, and anterior cranial fossa. The mean follow-up for this cohort was 12.8 months. No intraoperative complications were noted. Postoperative complications were reviewed with respect to the approach. To date, there have been no cases of residual tumor or tumor recurrence that can be attributed to the procedure., Conclusions: Our experience suggests that the Le Fort I osteotomy approach is a useful technique for the removal of extensive central skull base tumors and paranasal sinuses in the pediatric age group. It has distinct advantages over traditional anterior or lateral approaches, including a more direct line of vision and improved exposure and cosmesis.

Objective: To review the effectiveness of a perioperative management protocol and our experience with a large population of patients with von Willebrand disease (vWD) who require adenotonsillar surgery (T&A)., Design: A retrospective review of the medical records of all patients having the diagnosis of vWD who underwent T&A between January 1, 1992, and July 31, 1996., Setting: A tertiary care, university-based children's hospital., Interventions: Patients having a preoperative diagnosis of vWD received a single intravenous dose of desmopressin acetate, 0.3 pg/kg, approximately 20 minutes before the induction of anesthesia. Beginning January 15, 1994, a standard management protocol involving the postoperative administration of fluids and electrolytes was followed., Main Outcome Measures: Operative blood loss and the incidence of postoperative bleeding and of hyponatremia., Results: Of approximately 4800 patients who underwent T&A during the study period, 69 patients had a diagnosis of vWD. All 67 patients identified preoperatively received desmopressin; 2 were identified by postoperative workup as a result of excessive surgical bleeding. Minimal immediate postoperative bleeding was noted in 7 patients (10%), but none required intervention. Delayed bleeding occurred in 9 patients (13%); all were readmitted to the hospital for observation, 4 (6%) requiring operative cauterization. Substantial postoperative hyponatremia occurred in 3 patients, and 1 patient had seizure activity. Symptomatic hyponatremia has been avoided since a protocol of fluid and electrolyte administration was instituted., Conclusions: Although T&A can be performed safely in patients with vWD, it is not without an increased risk of postoperative hemorrhage. The administration of desmopressin has been reported to reduce the risk of bleeding, but it is not without risk. A protocol for fluid and electrolyte management is recommended.

Objective: To compare the postoperative course and complications after tonsillectomy or tonsillectomy and adenoidectomy in children with Down syndrome (group 1) with the postoperative course and complications in children in a control group (group 2)., Design: Retrospective review of medical records for the period January 1, 1986, through March 30, 1996., Setting: Tertiary care children's hospital., Patients: The study included 87 children in group 1 and 64 children in group 2 matched for age, sex, and year of surgery., Intervention: Tonsillectomy and adenoidectomy (group 1, 79 children; group 2, 57 children) and tonsillectomy (group 1, 8 children; group 2, 7 children)., Main Outcome Measures: Length of hospitalization and postoperative complications., Results: The length of hospitalization was significantly increased for the children in group 1 compared with that of children in group 2 (1.6 vs 0.80 days; P=.001, Mann-Whitney U test). Twenty-two children (25%) in group 1 required airway management or observation in the pediatric intensive care unit compared with no children in group 2 who required such care (P<.001, Fisher exact test). None of the children in either group required reintubation, continuous positive airway pressure, or tracheotomy. Respiratory complications requiring intervention were 5 times more likely in group 1 (22 [25%] vs 3 [5%]; P<.001, Fisher exact test). The median time until intake of clear liquids and duration of intravenous therapy were significantly increased in group 1 compared with group 2 (5.0 vs 4.0 hours, P=.03; 23.5 vs 16.0 hours, P=.001, respectively; Mann-Whitney U test)., Conclusions: Although tonsillectomy and adenoidectomy can be performed safely in children with Down syndrome, the rate of postoperative respiratory complications is higher and the duration until adequate oral intake is resumed is longer. We therefore recommend that children with Down syndrome be admitted to the hospital overnight after undergoing tonsillectomy and adenoidectomy.