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Multicenter Study
. 2020 May;130 Suppl 4(Suppl 4):S1-S9.
doi: 10.1002/lary.28612. Epub 2020 Mar 11.

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

Lawrence R Lustig  1 , Amy Ingram  2 , D Macy Vidrine  3 , Andrew R Gould  2 , Jacob W Zeiders  4 , Randall A Ow  5 , Christopher R Thompson  6 , Jonathan R Moss  7 , Ritvik Mehta  8 , John E McClay  9 , Amy Brenski  9 , John Gavin  10 , Erik H Waldman  11 , John Ansley  12 , David M Yen  13 , Neil K Chadha  14 , Michael T Murray  15 , Frederick K Kozak  14 , Christopher York  16 , David M Brown  13 , Eli Grunstein  1 , Robert C Sprecher  17 , Denise A Sherman  17 , Scott R Schoem  18 , Robert Puchalski  3 , Susannah Hills  1 , Audrey Calzada  8 , Dan Harfe  19 , Laura J England  19 , Charles A Syms 3rd  20
Affiliations
Multicenter Study

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

Lawrence R Lustig et al. Laryngoscope. 2020 May.

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.

Keywords: Iontophoresis; local anesthesia; myringotomy; office surgery; pediatric; tympanostomy tube.

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Figures

Figure 1
Figure 1
Tympanostomy tube dimensions.
Figure 2
Figure 2
Enrollment summary. OR = Operating Room.
Figure 3
Figure 3
Histogram of ages of children treated in the office setting.
Figure 4
Figure 4
Parent survey conducted at 3‐week follow‐up visit, Pivotal cohort. A = agree; D = disagree; N = neutral; SA = strongly agree; SD = strongly disagree.
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References

    1. Centers for Disease Control and Prevention , National Center for Health Statistics, National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey. United States, 2008. Available at: https://www.cdc.gov/nchs/data/ahcd/preliminary2008/table02.pdf. Accessed March 6, 2020.
    1. Stangerup SE, Tos M. Epidemiology of acute suppurative otitis media. Am J Otolaryngol 1986;7:47–54. - PubMed
    1. Grijalva CG, Nuorti JP, Griffin MR. Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. JAMA 2009;302:758–766. - PMC - PubMed
    1. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. American Academy of Pediatrics, clinical practice guideline. Pediatrics 2013;131:e964–e999. - PubMed
    1. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion executive summary (update). Otolaryngol Head Neck Surg 2016;154:201–214. - PubMed

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