In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.
Publication/Presentation Date
5-1-2020
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 thegroups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children89.2% (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.
Volume
130 Suppl 4
Issue
Suppl 4
First Page
1
Last Page
1
ISSN
1531-4995
Published In/Presented At
Lustig, L. R., Ingram, A., Vidrine, D. M., Gould, A. R., Zeiders, J. W., Ow, R. A., Thompson, C. R., Moss, J. R., Mehta, R., McClay, J. E., Brenski, A., Gavin, J., Waldman, E. H., Ansley, J., Yen, D. M., Chadha, N. K., Murray, M. T., Kozak, F. K., York, C., Brown, D. M., … Syms, C. A., 3rd (2020). In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. The Laryngoscope, 130 Suppl 4(Suppl 4), S1–S9. https://doi.org/10.1002/lary.28612
Disciplines
Medicine and Health Sciences
PubMedID
32160320
Department(s)
Department of Surgery
Document Type
Article