Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Lustig LR

PROVIDER: S-EPMC7187287 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Lustig Lawrence R LR Ingram Amy A Vidrine D Macy DM Gould Andrew R AR Zeiders Jacob W JW Ow Randall A RA Thompson Christopher R CR Moss Jonathan R JR Mehta Ritvik R McClay John E JE Brenski Amy A Gavin John J Waldman Erik H EH Ansley John J Yen David M DM Chadha Neil K NK Murray Michael T MT Kozak Frederick K FK York Christopher C Brown David M DM Grunstein Eli E Sprecher Robert C RC Sherman Denise A DA Schoem Scott R SR Puchalski Robert R Hills Susannah S Calzada Audrey A Harfe Dan D England Laura J LJ Syms Charles A CA

The Laryngoscope 20200311

<h4>Objectives/hypothesis</h4>Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.<h4>Study design</h4>Prospective individual cohort study.<h4>Methods</h4>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 my ...[more]

PMID: 32160320

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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.

Dataset Information

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

Publications

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

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