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Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated
Erik H Waldman1, Amy Ingram2, D Macy Vidrine3
1Yale New Haven Children's Hospital, New Haven, Connecticut, USA.
Insights
In-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and an automated device shows comparable tube retention and safety to traditional operating room procedures. This method offers a viable alternative for pediatric ear tube placement.
Area of Science:
- Otolaryngology
- Pediatric Surgery
- Anesthesiology
Background:
- Pediatric tympanostomy is a common surgical procedure.
- In-office placement aims to reduce costs and anesthesia risks.
- Novel techniques for local anesthesia and automated delivery are being explored.
Purpose of the Study:
- To evaluate the 2-year outcomes of in-office pediatric tympanostomy.
- To assess tube retention, patency, and safety using lidocaine/epinephrine iontophoresis and an automated tube delivery system.
- To compare in-office outcomes with traditional operating room procedures.
Main Methods:
- Prospective, single-arm study in 18 otolaryngology practices.
- Enrolled children aged 6 months to 12 years requiring tympanostomy.
- Utilized lidocaine/epinephrine iontophoresis for local anesthesia and an automated tube delivery system (Tula® System).
- A lead-in cohort underwent operating room placement under general anesthesia for comparison.
Main Results:
- 269 patients (449 ears) underwent in-office placement; 68 patients (131 ears) underwent operating room placement.
- Median time to tube extrusion was 15.82 months (OR) and 16.79 months (in-office).
- Complication rates were low, including 1.9% ongoing perforation and 0.2% medial tube displacement.
- Otorrhea occurred in 30.3% and tube occlusion in 14.3% of ears.
Conclusions:
- In-office pediatric tympanostomy with lidocaine/epinephrine iontophoresis and automated tube delivery demonstrates effective tube retention.
- Safety and complication rates are consistent with traditional operating room tympanostomy.
- This in-office approach presents a safe and effective alternative for pediatric ear tube placement.
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.
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