Ototopical therapies for post tympanostomy tube otorrhoea in children.
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ABSTRACT:
SUBMITTER: Mather MW
PROVIDER: S-EPMC9636450 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
Publications
Ototopical therapies for post tympanostomy tube otorrhoea in children.
Mather Michael W MW Talks Benjamin B Dawe Nicholas N Powell Jason J
Translational pediatrics 20221001 10
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Project description:Objectives/hypothesisEvaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.Study designProspective individual cohort study.MethodsThis 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).ResultsChildren 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.ConclusionsIn-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 evidence2b Laryngoscope, 130:S1-S9, 2020.
| S-EPMC7187287 | biostudies-literature
Project description: Not available
| S-EPMC10605420 | biostudies-literature
Project description:Objectives(1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices.Study designProspective, multicenter, single arm.SettingPatients were recruited in 8 community-based practices in the United States between June and September 2017.Subjects and methodsThis study evaluated tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog scale from 0 mm (no pain) to 100 mm (worst possible pain). Mean pain score was compared to a performance goal of 45 mm, where statistical superiority represents mild pain or less. Technical success and safety through 3 weeks postprocedure were evaluated.ResultsTwenty-nine (29/30, 96.7%) patients had tube(s) successfully placed in all indicated ears. One patient demonstrated inadequate tympanic membrane anesthesia, and no tube placement was attempted. The mean (SD) pain score of 9.4 (15.7) mm was statistically superior to the performance goal. There were no serious adverse events. Seven nonserious events were related to device, procedure, or drug: inadequate anesthesia (1), vertigo (1), and dizziness (1) at the time of procedure and ear discomfort (1), tube occlusion (2), and medial tube migration (1) postprocedure.ConclusionLidocaine iontophoresis provides acceptable tympanic membrane anesthesia for safe, tolerable, and successful in-office tube placement using an integrated myringotomy and tube delivery system.
| S-EPMC7040928 | biostudies-literature
Project description:BackgroundBecause previous studies have indicated that otitis media may be a polymicrobial disease, we prospectively analyzed middle ear effusions of children undergoing tympanostomy tube placement with multiplex polymerase chain reaction for four otopathogens.MethodsMiddle ear effusions from 207 children undergoing routine tympanostomy tube placement were collected and were classified by the surgeon as acute otitis media (AOM) for purulent effusions and as otitis media with effusion (OME) for non-purulent effusions. DNA was isolated from these samples and analyzed with multiplex polymerase chain reaction for Haemophilus influenzae, Streptococcus pneumoniae, Alloiococcus otitidis, and Moraxella catarrhalis.Results119 (57%) of 207 patients were PCR positive for at least one of these four organisms. 36 (30%) of the positive samples indicated the presence of more than one bacterial species. Patient samples were further separated into 2 groups based on clinical presentation at the time of surgery. Samples were categorized as acute otitis media (AOM) if pus was observed behind the tympanic membrane. If no pus was present, samples were categorized as otitis media with effusion (OME). Bacteria were identified in most of the children with AOM (87%) and half the children with OME (51%, p < 0.001). A single bacterial organism was detected in middle ear effusions from children with AOM more often than those with OME (74% versus 33%, p < 0.001). Haemophilus influenzae was the predominant single organism and caused 58% of all AOM in this study. Alloiococcus otitidis and Moraxella catarrhalis were more frequently identified in middle ear effusions than Streptococcus pneumoniae.ConclusionsHaemophilus influenzae, Streptococcus pneumoniae, Alloiococcus otitidis, and Moraxella catarrhalis were identified in the middle ear effusions of some patients with otitis media. Overall, we found AOM is predominantly a single organism infection and most commonly from Haemophilus influenzae. In contrast, OME infections had a more equal distribution of single organisms, polymicrobial entities, and non-bacterial agents.
| S-EPMC3475091 | biostudies-literature
Project description:BackgroundTympanostomy tube insertion (TTI) is one of the primary treatments for Otitis media with effusion (OME) in children, a common condition in children. However, there is still no conclusion on the better choice of tube position, and no relevant research has been found in the literature. This study analyzed the results of the two commonly selected tube insert positions, anteroinferior quadrant (AQ) and posteroinferior quadrant (PQ), in order to determine which is the better choice.MethodsChildren with bilateral OME who received TTI in Beijing Tongren Hospital from May 2020 to January 2021 were selected as subjects. one side on AQ and the other side on PQ randomly. Follow-up visits were arranged at 1 week, 1 month, 6 months and 12 months after surgery. The results of audiology and the tube status of the two positions were recorded and compared statistically.ResultsA total of 90 patients with bilateral OME were selected. There was no difference in preoperative hearing between the 2 groups. The AQ group's average air conduction threshold was significantly higher than that of the PQ group 1 week after surgery. Although there was no significant difference in tube fall-off rate between the two groups within 6 months, it was significantly higher in AQ group than that in PQ group at 12 months after surgery.ConclusionsCompared to TTI on AQ, TTI on PQ is more stable and better improves hearing, and the operation is also more convenient for surgeons. This study provides reference for a better position of TTI in OME therapy.
| S-EPMC9360827 | biostudies-literature
Project description:Simulators allow junior otolaryngology residents to practice the delicate procedure of pressure equalization tube (PET) insertion. However, most simulators lack the ability to mimic the differing anatomic complexities between patients, such as variable external auditory canal (EAC) size. We developed a novel low-cost, medium-fidelity 3-dimensional-printed PET simulator with different EAC sizes to better reflect procedure complexity. Additionally, a variety of materials were tested to mimic the elastic modulus of the tympanic membrane, with "Press'n Seal" cling film being chosen for its cost-effectiveness and tactile similarity. Ten otolaryngologists performed PET insertion on both EAC sizes followed by a survey to assess face and content validity. Results indicated both high face and content validity, with most participants agreeing the simulator provided a realistic experience and would be useful for training. While our study has a small sample size, our PET simulator adds a unique and valuable addition to PET training.
| S-EPMC11764988 | biostudies-literature
Project description:AimThe aim was to estimate the impact of the 10-valent pneumococcal vaccine (PHiD-CV) on tympanostomy tube placements (TTP) in children under five years of age in Iceland.MethodsThis population-based observational cohort study followed 11 consecutive birth-cohorts 2005-2015 from birth until their fifth birthday. Population registries were merged using national identification numbers. The risk of TTP was compared between birth-cohorts adjusted for the number of previous otitis media diagnoses and antimicrobial prescriptions. A Cox regression model was applied and the hazard ratio (HR) of TTP was estimated between each birth-cohort and the last vaccine non-eligible birth-cohort. The vaccine impact of PHiD-CV10 on TTP was estimated as 1-HR ×100%.ResultsIn total, 51 247 children were followed for 210 724 person-years, of which 14 351 underwent 20 373 procedures. The estimated vaccine impact on TTP was -6% (95% CI -16% to 2.7%). Children in the vaccine-eligible cohorts had fewer previous otitis media diagnoses and had been prescribed fewer antimicrobials prior to the procedure than children in the vaccine non-eligible cohorts.ConclusionDespite high uptake of PHiD-CV10, tympanostomy procedures increased in Iceland during the study period. Vaccine-eligible children had milder disease prior to the procedure. The reason underlying these findings are speculative.
| S-EPMC6767502 | biostudies-literature
Project description:Occlusion of the T-tube (tympanostomy tube) is a common postoperative sequela related to bacterial biofilms. Confronting biofilm-related infections of T-tubes, maneuverable and effective treatments are still challenging presently. Here, we propose an endoscopy-assisted treatment procedure based on the wobbling Fe2O3 helical micromachine (HMM) with peroxidase-mimicking activity. Different from the ideal corkscrew motion, the Fe2O3 HMM applies a wobbling motion in the tube, inducing stronger mechanical force and fluid convections, which not only damages the biofilm occlusion into debris quickly but also enhances the catalytic generation and diffusion of reactive oxygen species (ROS) for killing bacteria cells. Moreover, the treatment procedure, which integrated the delivery, actuation, and retrieval of Fe2O3 HMM, was validated in the T-tube implanted in a human cadaver ex vivo. It enables the visual operation with ease and is gentle to the tympanic membrane and ossicles, which is promising in the clinical application.
| S-EPMC9544342 | biostudies-literature
Project description:Objective to report outcomes of balloon dilation Eustachian tuboplasty combined with tympanostomy tube insertion and middle ear pressure equalization therapy in treatment of recurrent secretory otitis media. Methods Fifty one patients with recurrent secretory otitis media (62 ears) underwent balloon dilation of Eustachian tube and tympanic tube insertion under general anesthesia, followed by long term middle ear pressure equalization therapies. The Eustachian tube score (ETS) and Eustachian tube function questionnaire (ETDQ-7) were used for pre- and postoperative (up to 12 months) evaluation of Eustachian tube functions. Results The mean ETS score was 2.34 ± 0.97 preoperatively, and 6.17 ± 1.54, 7.23 ± 1.62, 8.24 ± 1.97, and 7.63 ± 1.86 at 1, 3, 6 and 12 months postoperatively, respectively (P < 0.05). The ETDQ-7 score was 4.82 ± 1.07 preoperatively, and 2.20 ± 0.54, 2.32 ± 0.68, 2.53 ± 0.79, and 2.67 ± 0.76 at 1, 3, 6 and 12 months postoperatively, respectively (P < 0.05). Conclusion Balloon dilation of Eustachian tube combined with tympanostomy and catheterization resulted in significant improvement of subjective symptoms and objective evaluation of Eustachian tube functions in most patients with recurrent secretory otitis media, as indicated by the ETS and ETDQ-7 scores, demonstrating high levels of efficacy and patient satisfaction.
| S-EPMC6712345 | biostudies-literature
Project description:ObjectiveThis 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.MethodsDouble-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).ResultsEighty-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.ConclusionsResults of this first clinical trial suggest that OTO-201 was well tolerated and shows preliminary clinical activity in treating tympanostomy tube otorrhea.
| S-EPMC4707869 | biostudies-literature