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. 2023 Sep;169(3):701-709.
doi: 10.1002/ohn.336. Epub 2023 Apr 1.

Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System

Erik H Waldman  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 , John Ansley  11 , David M Yen  12 , Neil K Chadha  13 , Michael T Murray  14 , Frederick K Kozak  13 , Christopher York  15 , David M Brown  12 , Eli Grunstein  16 , Robert C Sprecher  17 , Denise A Sherman  17 , Scott R Schoem  18 , Robert Puchalski  3 , Susannah Hills  16 , Dan Harfe  19 , Laura J England  19 , Charles A Syms  20 , Lawrence R Lustig  16
Affiliations

Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System

Erik H Waldman et al. Otolaryngol Head Neck Surg. 2023 Sep.

Abstract

Objective: Evaluate 2-year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in-office.

Study design: Prospective, single-arm.

Setting: Eighteen otolaryngology practices.

Methods: Children age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead-In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated.

Results: Tubes were placed in-office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In-Office cohorts were 15.82 (95% confidence interval [CI]: 15.41-19.05) and 16.79 (95% CI: 16.16-17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow-up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes.

Conclusion: In-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet-type tubes and complication rates consistent with traditional tube placement in the OR.

Keywords: Tula; automated tube insertion; iontophoresis; local anesthesia; office tympanostomy; pediatric; tympanostomy tube.

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References

    1. Hersh AL, Fleming-Dutra KE, Shapiro DJ, Hyun DY, Hicks LA, Outpatient Antibiotic Use Target-Setting Workgroup. Frequency of first-line antibiotic selection among US ambulatory care visits for otitis media, sinusitis, and pharyngitis. JAMA Intern Med. 2016;176(12):1870-1872. doi:10.1001/jamainternmed.2016.6625
    1. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA. 2016;315(17):1864-1873. doi:10.1001/jama.2016.4151
    1. Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022;166(1_suppl):S1-S55. doi:10.1177/01945998211065662
    1. Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010. Natl Health Stat Rep. 2017;(102):1-15.
    1. Rosenfeld RM, Tunkel DE, Schwartz SR. Office insertion of tympanostomy tubes and the role of automated insertion devices. Otolaryngol Head Neck Surg. 2022;166(2):219-223. doi:10.1177/01945998221074528

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