Tympanostomy Tube Placement In Children Research Articles

Racial and Ethnic Disparities in Otolaryngology Office Visit and Tympanostomy Tube Placement in Children with Otitis Media.

Racial disparities are pervasive in access to pediatric surgery. The goal of this study was to test the hypotheses that, compared with White children, non-White and Hispanic children: (1) were less likely to attend evaluations by otolaryngologists after a diagnosis of otitis media (OM) eligible for surgical referral, and (2) these children were less likely to receive tympanostomy tube (TT) after surgical consultation. The OptumLabs Data Warehouse is a de-identified claims database of privately insured enrollees. Guidelines on the management of OMs suggest that children should be evaluated for surgery if they have recurrent acute OM or chronic OM with effusion. A cohort of children who were diagnosed with OM were constructed. For Hypothesis 1, the primary outcome was otolaryngology office visit within 6 months of a diagnosis of recurrent or chronic OM. For Hypothesis 2, the outcome was TT placement within 6 months following the otolaryngology office visit. Cox regression models were used to determine the relationship between race/ethnicity and the primary outcomes. Among 187,776 children with OMs, 72,774 (38.8%) had otolaryngology visits. In a multivariate Cox model, the hazard ratios of attending otolaryngology visit for Black, Hispanic, and Asian children were 0.93 (95% CI,0.90, 0.96), 0.86 (0.83, 0.88), and 0.74 (0.71, 0.77), compared with White children. Among the children evaluated by otolaryngologists, 46,554 (63.97%) received TT. Black, Hispanic, and Asian children with recurrent acute OM had lower likelihood of receiving TT. Racial disparities in attending otolaryngology office visit contributed to the disparities in receiving TT. Level 3 Laryngoscope, 2024.

Efficacy of tympanostomy tube placement with adjuvant adenoidectomy in children less than 4 years of age

ObjectiveAbout 8.6 % of children in the United States undergo tympanostomy tube (TT) placement every year. Of these, 24.1 % require a second set of tubes. Adjuvant adenoidectomy in children over 4 years is thought to improve the efficacy of TT. The goal of this study is to characterize the efficacy of adjuvant adenoidectomy at the time of TT placement in children under 4 years, to further improve middle ear function. MethodsAll patients undergoing TT placement alone or TT placement with adenoidectomy from 2014-2016 were reviewed. The primary outcome was need for subsequent tube placement. ResultsA total of 409 patients were included in the study (60.6 % male, 39.4 % female). Median age at initial TT placement was 18 months (range 5–48 months); extreme outliers for age were removed from further analysis. Patients were followed for 1–8 years. 250 patients received TT alone while 159 received TT with adenoidectomy. 120 required a second set of tubes. There was a statistically significant benefit to those undergoing adjuvant adenoidectomy with TT placement: 33.6 % of those receiving TT alone required subsequent tubes, whereas only 22.6 % of patients who underwent TT with adjuvant adenoidectomy required reinsertion (X2 = 5.630, p = 0.018). Adjuvant adenoidectomy in patients 0–48 months was associated with decreased likelihood of requiring subsequent tube placement (OR = 0.578, p = 0.018). There was an increased likelihood of experiencing otorrhea in those receiving TT alone compared to the TT with adenoidectomy group (X2 = 4.353, df = 1, p = 0.0369). ConclusionAdjuvant adenoidectomy at the time of initial TT placement may have a role in the management of chronic middle ear disease in patients younger than 4 years. However, further studies and prospective randomized studies are needed to explore if this benefit can also be seen in children without chronic rhinosinusitis or nasal obstruction. The benefit-risk ratio from adenoidectomy and modifications in anesthesia technique in the case of adjuvant adenoidectomy should also be further explored.

Long-term efficacy of balloon dilation of the pediatric Eustachian tube: A six-year matched cohort study

PurposeBalloon dilation of the Eustachian tube (BDET) has not been evaluated extensively in children outside of retrospective case series. The purpose of this study is to report the long-term safety and efficacy of this procedure in children with matched controls. Materials and methodsThis is a two-center retrospective matched cohort study. Children having undergone tympanostomy tube (TT) placement and adenoidectomy with recurrence of symptoms underwent BDET at an academic affiliated multi-specialty practice. Comparison was made with children receiving TT at a tertiary medical center, matching for number of prior TT, prior adenoidectomy, age, and sex. Outcome measures were risk of failure and the need for additional surgery. Kaplan-Meier survival plots were used to compare risk of failure. ResultsThirty-three Eustachian tubes were dilated in 20 patients, aged 14 months-14 years. All patients had previously undergone TT insertion and adenoidectomy. Patients undergoing BDET had normal post-operative tympanograms in 80 % of cases. Mean follow up was 6.7 years with 2 patients failing in the BDET group and 8 in the TT insertion group. Dilated patients had a significantly lower risk of failure than those who underwent TT insertion (adjusted HR: 0.18; 95 % CI: 0.04, 0.81; p = 0.03). The probability of being failure free at six years was 88 % (95 % CI: 71, 95 %) in the BDET cohort and 53 % (95 % CI: 33, 70 %) in the TT insertion cohort. There were no complications. ConclusionsBDET appears to be safe and possibly superior to TT placement in children with refractory Eustachian tube dysfunction. Level of evidence2b.

Tympanostomy Tube Placement in Children with Autism Spectrum Disorder.

The frequency of tympanostomy tube (TT) placement among United States children with autism spectrum disorder (ASD) is not known. We explored the rate of TT placement in children with ASD in the United States and compared this to children without ASD. We further examined demographic and behavioral factors that might vary between the two groups. We utilized data from the National Health Interview Survey (NHIS) administered in 2014. This survey samples a representative population of patients across the United States and includes children under 18 years of age. The 2014 version of the NHIS survey was chosen as it identifies both autism and TT placement among sampled patients. Descriptive statistics and univariable and multivariable logistic regression analyses were performed. In total, 11,730 children (239 [2.0%] with ASD) were included. Overall, 34 (14.2%) children with ASD underwent TT placement versus 987 (8.6%) in children without ASD (p=0.002) ASD diagnosis was associated with increased odds of TT placement (1.52 OR, 95% CI 1.04-2.22). Male sex, white race, and non-Hispanic ethnicity were also associated with increased odds of TT placement. Age at the time of TT surgery was not different between those with versus without ASD. Children with ASD have an increased rate of TT placement compared to children without ASD. The reason(s) for this increased rate might include the following: higher rates of infection in ASD, over-diagnosis of ear infection or hearing disability in a difficult-to-examine population, and/or a predilection toward aggressive treatment in this at-risk group. 3-National database study Laryngoscope, 133:2407-2412, 2023.

Predictive factors for repeated tympanostomy tube placement in children

To determine the rate and risk factors for additional tympanostomy tube (TT) placement after first set of TT extrusion in children. Single-centre cohort study. Clinical records of children undergoing TT placement from January 2015 to December 2017 were reviewed and factors related to the need for subsequent TT were evaluated. A total of 183 children were included, with a mean age of 5.45 ± 2.672 years old. All surgeries were performed simultaneously with adenoidectomy and 64.3% with tonsillectomy. The mean TT retention time was 12.13 ± 6.033 months and the rate of second TT insertion was 21.9%. The TT retention time was significantly lower in children who needed a second TT (8.97 ± 3.962 vs 13.05 ± 6.229, p < .001). Other factors significantly associated with the need for a second TT in the univariate analysis were the presence of otorrhoea and snoring after TT placement ( p = .042 and p = .02), RAOM ( p = .016), passive smoking ( p = .038) and rhinorrhoea ( p = .008). However, on multivariate analysis only TT retention time (OR = .831, 95% CI: .727–.950) and RAOM as an indication for surgery (OR: 5.767; 95% CI: 1.696–19.603) were predictors of a second TT. Gender, age, asthma, prematurity, and low birth weight were not significantly associated with a second TT. RAOM and a short TT retention time were significantly associated with additional TT placement, enhancing the need for and importance of follow up of these children after TT extrusion. Determinar la tasa y los factores de riesgo para la colocación de tubos de timpanostomía (TT) adicional después de la extrusión de los primeros TT en niños. Estudio retrospectivo de los registros médicos de los niños sometidos a la colocación de TT desde enero del 2015 hasta diciembre del 2017; se evaluaron los factores relacionados con la necesidad de TT posterior. Se incluyó a 183 niños, con una edad media de 5,45 ± 2,672 años. Todas las cirugías se realizaron simultáneamente con adenoidectomía y el 64,3% con amigdalectomía. El tiempo medio de retención del TT fue de 12,13 ± 6,033 meses y la tasa de segunda inserción del TT fue del 21,9%. El tiempo de retención del TT fue significativamente menor en los niños que necesitaron un segundo TT (8,97 ± 3,962 vs. 13,05 ± 6,229, p < 0,001). Otros factores asociados significativamente a la necesidad de un segundo TT en el análisis univariable fueron la presencia de otorrea y ronquidos tras la colocación del TT (p = 0,042 y p = 0,02, respectivamente), la otitis media aguda de repetición (OMAr) (p = 0,016), el tabaquismo pasivo (p = 0,038) y la rinorrea (p = 0,008). Sin embargo, en el análisis multivariado solo el tiempo de retención del TT (OR = 0,831, IC del 95%: 0,727-0,950) y la OMAr como indicación de cirugía (OR: 5,767; IC del 95%: 1,696-19,603) fueron predictores de un segundo TT. El sexo, la edad, el asma, la prematuridad y el bajo peso al nacer no se asociaron significativamente con un segundo TT. La OMAr y un corto tiempo de retención del TT se asociaron significativamente con la colocación de un segundo TT, lo que refuerza la necesidad e importancia del seguimiento de estos niños tras la extrusión del TT.

Predictive factors for repeated tympanostomy tube placement in children

ObjectivesTo determine the rate and risk factors for additional tympanostomy tube (TT) placement after first set of TT extrusion in children. Materials and methodsSingle-centre cohort study. Clinical records of children undergoing TT placement from January 2015 to December 2017 were reviewed and factors related to the need for subsequent TT were evaluated. ResultsA total of 183 children were included, with a mean age of 5.45±2.672 years old. All surgeries were performed simultaneously with adenoidectomy and 64.3% with tonsillectomy. The mean TT retention time was 12.13±6.033 months and the rate of second TT insertion was 21.9%. The TT retention time was significantly lower in children who needed a second TT (8.97±3.962 vs 13.05±6.229, p<.001). Other factors significantly associated with the need for a second TT in the univariate analysis were the presence of otorrhoea and snoring after TT placement (p=.042 and p=.02), RAOM (p=.016), passive smoking (p=.038) and rhinorrhoea (p=.008). However, on multivariate analysis only TT retention time (OR=.831, 95% CI: .727–.950) and RAOM as an indication for surgery (OR: 5.767; 95% CI: 1.696–19.603) were predictors of a second TT. Gender, age, asthma, prematurity, and low birth weight were not significantly associated with a second TT. ConclusionsRAOM and a short TT retention time were significantly associated with additional TT placement, enhancing the need for and importance of follow up of these children after TT extrusion.

Outcome of the ‘waiting until spontaneous extrusion’ strategy for long-term tympanostomy tube placement in children with cleft palate

Background Otitis media with effusion (OME) in children with cleft palate (CP) is known to be refractory to treatment and most of these patients undergo surgery for ventilation tube (VT) placement. Objectives To identify the outcomes of children with CP using long-term VT with a ‘waiting until spontaneous extrusion’ strategy. Material and methods We retrospectively reviewed the medical records of all children with CP who visited our department from December 2016 to November 2017 and who received long-term VT placement in our department. Risk factors related to residual perforation and recurrence of OME were analyzed. Results A total of 106 children were included in this study. Our statistical analysis of 94 ears followed for more than three months after VT loss revealed that longer VT placement was associated with residual perforation, and shorter VT placement was associated with OME recurrence. Although a longer duration of VT placement was associated with an increased rate, extremely long-term VT placement was not associated with residual perforation, as expected. Half of the VTs were spontaneously extruded at 40 months after insertion. Conclusions and Significance Long-term VT insertion using a waiting until spontaneous extrusion strategy is a potential option for children with CP.

The limits of pandemic precautions: Tympanostomy tube placement in children with cleft palate during COVID-19

PurposeCoronavirus Disease-2019 (COVID-19) mitigation measures have led to a sustained reduction in tympanostomy tube (TT) placement in the general population. The present aim was to determine if TT placement has also decreased in children at risk for chronic otitis media with effusion (COME), such as those with cleft palate (CP). Materials and methodsA cohort study with medical record review was performed including consecutive children, ages 0–17 years, undergoing primary palatoplasty at a tertiary children's hospital February 2019–January 2020 (pre-COVID) or May 2020–April 2021 (COVID). Revision palatoplasty (n = 29) was excluded. Patient characteristics and middle ear status pre-operatively and at palatoplasty were compared between groups using logistic regression or Wilcoxon rank-sum. ResultsThe pre-COVID and COVID cohorts included 73 and 87 patients, respectively. Seventy (44%) were female and median age at palatoplasty was 13.5 months for CP ± cleft lip (CP ± L) and 5.5 years for submucous cleft palate (SMCP). In patients with CP ± L, TT were placed or in place and patent at palatoplasty in 28/38 (74%) pre-COVID and 37/50 (74%) during COVID (P = 0.97). In patients with SMCP, these proportions were 5/35 (14%) and 6/37 (16%), respectively (P = 0.82). Examining only patients <2 years of age also revealed no difference in TT placement pre-COVID versus COVID (P = 0.99). Finally, the prevalence and type of effusion during COVID was similar to pre-COVID. ConclusionsReduced infectious exposure has not decreased TT placement or effusion at palatoplasty. Future work could focus on non-infectious immunologic factors underlying the maintenance of COME in these children.

Issues of tympanostomy tube placement in children with otitis media with effusion

Issues of tympanostomy tube placement in children with otitis media with effusion

In Response to Letter to the Editor Regarding In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery

In Response to Letter to the Editor Regarding <i>In</i>‐<i>Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery</i>

Combined intranasal fentanyl and dexmedetomidine plus inhaled nitrous oxide sedation in children needing myringotomy and ventilation tube insertion with a specific handheld device

ObjectivesWe report a case series of one-time 4 mcg/kg dose of intranasal dexmedetomidine and 1 mcg/kg of intranasal fentanyl plus inhaled nitrous oxide for procedural sedation in children with otitis media with effusion (OME) for tympanostomy tube placement with a specific handheld device (Solo TTD, AventaMed ®). MethodsA retrospective review was conducted in a tertiary paediatric teaching hospital on patients with OME referred from December 2018 to December 2019 in need of procedural sedation for myringotomy and ventilation tube insertion (VTI). Sixteen of twenty-four consecutively admitted subjects received a one-time dose (4 mcg/kg) of intranasal dexmedetomidine and 1mcg/Kg of intranasal fentanyl followed by inhaled nitrous oxide (iN2O) at 50% with the intended goal to achieve a Ramsay Sedation Score 4 allowing a motionless procedure with adequate analgesia. Parents’ satisfaction for the procedure was measured by mean of a Likert scale (from 0 to 5 points). ResultsSixteen patients underwent procedural sedation for myringotomy with VTI. Sedation was achieved successfully in fifteen patients (93,75%), with a mean induction time of 29 min (range 19–43) and a mean recovery time of 74 min (range 54–110). The patient who did reach an adequate sedation level underwent an intravenous line positioning and a dose of ketamine. No adverse effects were reported, and the parents’ judgment average on the Likert scale was 4,93. VTI procedure was successful in all ears. ConclusionsA combination of intranasal dexmedetomidine, fentanyl, and iN2O could be considered as a possible option for procedural sedation in children with OME undergoing procedural sedation for tympanostomy tube placement in children with Solo TTD device.

Rate and risk factors for post-adenotonsillectomy complications in children under 24months and 24 to 36months old.

The primary purpose of this study was to assess the overall rate of postoperative complications after adenotonsillectomy in children under 24months old relative to children 24-36months old. Our secondary goal focused on quantifying specific preoperative risk factors that predispose children to postoperative complications. We retrospectively reviewed 248 patients who underwent adenotonsillectomy at our ENT office from 2006 to 2011. We stratified these patients into two groups: under 2years old; and 2-3years old. We identified 42 preoperative risk factors and 22 postoperative complications for each age group and conducted tests of statistical significance. We found that children under 24months old had a statistically significant higher postoperative complication rate of 38% compared to 22.3% in children 2-3years old (p=0.0320, chi-squared test). For specific complications, younger children had a higher rate of respiratory distress within 24h (p=0.0355), endotracheal re-intubation (p=0.0281), and retractions (p=0.0281). The only identified risk factors aside from age demonstrating statistical significance were nasal steroid sprays used preoperatively in children under 24months (p=0.005) and concurrent tympanostomy tube placement in children 24-36months (p=0.026). Our data demonstrates that children under 2years of age have an overall increased rate of postoperative complications after adenotonsillectomy when compared to children between 2 and 3years old, with a significantly higher rates of early respiratory distress, endotracheal re-intubation, and retractions. This study is one of the largest that compares postoperative complication rates and risk factors after adenotonsillectomy in this age group.

Table of contents

The LaryngoscopeVolume 130, Issue S4 p. v-v Issue InformationFree Access Table of contents First published: 10 April 2020 https://doi.org/10.1002/lary.28683AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume130, IssueS4Supplement: In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube DeliveryMay 2020Pages v-v RelatedInformation

Preventing unnecessary tympanostomy tube placement in children

ObjectiveIn 2013 the American Academy of Otolaryngology published tympanostomy tube guidelines for children; Action Statement 6 recommends against tube placement without middle ear effusion (MEE) at time of assessment. To date, little research has directly evaluated this recommendation in reducing the need for ear tubes. We evaluated the effectiveness of this recommendation and potential risk factors that influence the success of watchful waiting. MethodsRetrospective chart review collecting demographics, daycare status, smoking exposure, and time of year of visit. Children aged 6 months to 12 years without MEE on presentation, but with 3 or more episodes of acute otitis media (AOM) in 6 months or 4 or more episodes in 12 months, were assigned to watchful waiting (WW) treatment. These patients were followed every 4 months or returned sooner with additional infections. Any continued AOM, or MEE on follow up leading to tube placement, defined WW failure. Results123 patients met criteria, with 81 still in WW to date (66% success rate). 42 children failed WW and received tympanostomy tubes (34% failure rate). There were no statistically significant associations between age, race, gender, smoking exposure, daycare, or month of presentation between children who failed WW compared to children receiving tubes. ConclusionsTympanostomy tube guidelines mitigate unnecessary tube placement in a majority of children with recurrent AOM without MEE. To our knowledge, this is the first study supporting the 2013 recommendations, with a 66% success rate. Additionally, no significant associations between modifying risk factors in those who failed watchful waiting were identified.

Second tympanostomy tube placement in children with recurrent acute otitis media.

To determine the rate and predictors of electing for a second bilateral myringotomy and tympanostomy tube placement (BMT) in children with recurrent acute otitis media (RAOM). Retrospective chart review. Charts of 600 children who underwent BMT for RAOM between 2012 and 2014 were reviewed. The overall rate of a second BMT was 15.2% (91/600) and occurred a median of 1.58 years after the initial BMT. The most common indication was continued RAOM with extruded tubes. There was a higher rate of second BMT in patients of younger age (1.06 vs. 1.32 years old, P < .001) and those with a positive family history of RAOM/BMT in a first-degree relative (odds ratio [OR]: 1.67, 95% confidence interval [CI]: 1.02-2.73, P = .041). Identification of middle ear fluid intraoperatively (OR: 1.99, 95% CI: 1.22-3.26, P = .005) but not preoperatively (OR: 1.88, 95% CI: 0.98-3.57, P = .051) was associated with higher rates of second BMT. Children with bilateral intraoperative fluid (OR: 2.25, 95% CI: 1.42-3.58, P < .001) or fluid both preoperatively and intraoperatively (OR: 2.25, 95% CI: 1.40-3.61, P = .001) had greater higher risk of requiring second BMT. In this series, the finding of blocked tubes or tube otorrhea at the first postoperative visit were not predictive of an increased risk of second BMT. Children who underwent BMT for RAOM were more likely to undergo second BMT if they were of younger age, had a family history of RAOM/BMT, or were found to have middle ear fluid intraoperatively. The overall second BMT rate for children with RAOM is lower than in studies examining all BMT indications. 4. Laryngoscope, 128:1476-1479, 2018.

Tympanostomy Tube Placement in Children Using a Single-Pass Tool with Moderate Sedation.

Insertion of tympanostomy tubes is a common elective pediatric surgical procedure and is typically performed under general anesthesia. The potential to reduce general anesthetic requirements for young children has led to increased interest in alternatives for tympanostomy tube placement. A tympanostomy tube system, developed to enable tympanostomy tube placement in a single pass on conscious patients under moderate sedation, was evaluated. A prospective study on 128 children and 253 tympanostomy tube placements conducted at 4 centers in the United States demonstrated an 88.3% success rate in performing the procedure under moderate sedation with adverse events within normal rates reported in the literature. The feasibility of completing tympanostomy tube placement under moderate sedation enables avoidance of general anesthesia and provides additional choices to physicians and parents.

The Treatment of Otorrhea in Children with Cleft Palate: An Institutional Review

We conducted a retrospective observational chart review to characterize otorrhea in patients with cleft palate (CP) after tympanostomy tube placement in terms of the bacteria profile, treatment effectiveness, and overall disease burden. A total of 157 patients over 6 years were reviewed. Fifty of the 157 patients (31.8%) experienced postoperative otorrhea. Of the 50 patients with otorrhea, all received topical antibiotics, 30 received oral antibiotics, and 12 received povidone-iodine irrigations. The average duration of otorrhea was 5.2 months for patients with povidone-iodine irrigations and 8.5 months for those without povidone-iodine irrigations. Methicillin-resistant Staphylococcus aureus was the most commonly cultured microorganism. The average number of total healthcare visits over a 12-month period was 13.6 per patient. We conclude that postoperative otorrhea is a common problem after tympanostomy tube placement in children with CP and places a significant burden on these patients and the healthcare system. The bacteriologic profile may be different in this population compared with the non-CP population with otorrhea after tympanostomy, and a search for more effective treatment options is warranted, including further investigation into povidone-iodine irrigations.

Intranasal fluticasone associated with delayed tympanostomy tube placement in children with eustachian tube dysfunction

ObjectivesPediatric patient caregivers may prefer to avoid a surgical intervention and request a medical management option for eustachian tube dysfunction (ETD). However, there are limited published data evaluating the efficacy of intranasal fluticasone in the medical management of ETD as an alternative to tympanostomy tube placement. The objectives of this study were to: 1) determine if intranasal fluticasone (INF) prevented tympanostomy tube placement in children with ETD, and 2) describe differences in patient response to INF related to cleft lip and/or palate (CLP) and Down syndrome. MethodsCase series with planned chart review at a Tertiary academic hospital. We reviewed pediatric patients treated with INF for ETD. Inclusion criteria included ETD, no prior intranasal or oral steroid therapy, and no prior tympanostomy tube placement. Outcomes included time-to- tympanostomy tube placement with or without INF and therapy compliance. Kaplan-Meier survival analyses with log-rank tests and Fisher's exact tests were used to examine outcome variables. Results676 fulfilled inclusion criteria. 393 (58.7%) were male, and 355 (52.5%) Caucasian with mean age of 27.1 months old. 92 (13.6%) had CLP and 46 (6.8%) had Down Syndrome. 266 (39.4%) received INF, and 202 (88.2%) were compliant at their next visit. 474 (70.1%) had tympanostomy tubes placed. Children treated with INF were less likely to have tympanostomy tubes placed than children not treated (52.6% vs. 81.5%; p < 0.0001). Using survival analyses, INF use was associated with significantly longer mean time-to-tympanostomy tube than no INF use (199.4 vs. 133.7 days; p < 0.0001). INF did not reduce time-to-tympanostomy tube in patients with CLP (p = 0.05) or Down Syndrome (p = 0.27). ConclusionINF significantly reduces the number of children requiring tympanostomy tube placement for ETD. The CLP and Down Syndrome anatomical variants may attenuate INF efficacy. Further in vivo characterization of INF action on eustachian tube tissues will help further substantiate these observations.

Behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation

ObjectiveTympanostomy tube insertion is the most common pediatric surgery, but it typically requires general anesthesia. To facilitate in-office tube placement without general anesthesia, two complementary technologies have recently been developed comprising an iontophoresis system for delivering local anesthesia and an integrated tube delivery system. The purpose of this study was to evaluate behavioral support techniques used during a clinical study of the new technology for pediatric in-office tube placement without general anesthesia or physical restraints. MethodsAs part of an IRB-approved, prospective, nine-center clinical study, pediatric patients requiring tube insertion underwent in-office treatment using the new procedure. The behavior management techniques included preparation, distraction, coaching, and reinforcement for cooperation. The entire procedure was videotaped and two independent coders used the validated FLACC (Face, Legs, Activity, Cry, Consolability) scale to code behavioral distress across five procedural phases. ResultsSeventy pediatric patients aged 8 months to 17 years (M=7.0 years; 51% female) were enrolled in the study and 68 had video recordings available for analysis. Of the 68 recordings analyzed, 63 patients completed the procedure and had tubes placed without sedation. Mean FLACC scores ranged from 0.05 to 2.38 (M=1.25, SD=0.82) and median FLACC scores ranged from 0 to 1 (Mdn=0, IQR=0.05), which indicate “mild” distress. During iontophoresis, eardrum tap (anesthesia assessment), and tube delivery, older children displayed lower distress and girls had higher FLACC scores during the eardrum tap procedural phase. ConclusionWhen combined with the evidence-based behavioral techniques, office-based local anesthesia and tube delivery resulted in minimal distress, suggesting that the new procedure may be a viable method of conducting tympanostomy tube placement in children without having to use general anesthesia.Clinicaltrials.gov identifier: NCT01496287.

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).Results:Eighty-three patients (52 male/31 female; mean age, 2.80 years) were followed for safety (otoscopic exams, cultures, audiometry, and tympanometry) and clinical activity, defined as treatment failure (physician-documented otorrhea and/or otic or systemic antibiotic use ≥3 days post surgery). At baseline, 14.3% to 36.8% of children showed positive cultures of middle ear effusion samples in at least 1 ear. Through day 15, treatment failures accounted for 14.3%, 15.8%, 45.5%, and 42.9% of patients (OTO-201 4 mg, OTO-201 12 mg, placebo, and sham, respectively); treatment failure reductions for OTO-201 doses were significant compared to pooled control (P values = .023 and .043, respectively). Observed OTO-201 safety profile was indistinguishable from placebo or sham.Conclusions:Results of this first clinical trial suggest that OTO-201 was well tolerated and shows preliminary clinical activity in treating tympanostomy tube otorrhea.