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Published on: March 16, 2018
In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery
Lawrence R Lustig1, Amy Ingram2, D Macy Vidrine3
1Department of Otolaryngology - Head and Neck Surgery, Columbia University Medical Center, New York, New York, U.S.A.
Insights
This study shows that in-office tympanostomy tube placement is safe and effective for children using lidocaine iontophoresis anesthesia. The procedure successfully avoided sedatives and restraints, demonstrating good technical outcomes.
Area of Science:
- Otolaryngology
- Pediatric Surgery
- Anesthesiology
Background:
- Tympanostomy tube placement is a common pediatric procedure.
- Traditional methods often require sedation or general anesthesia.
- Office-based procedures aim to improve efficiency and reduce costs.
Purpose of the Study:
- To evaluate the technical success, tolerability, and safety of in-office tympanostomy tube placement in children.
- To assess the efficacy of lidocaine iontophoresis for local anesthesia.
- To determine if sedation or restraints are necessary for this procedure.
Main Methods:
- A prospective multicenter study involving children aged 6 months to 12 years.
- Lidocaine/epinephrine iontophoresis was used for anesthesia.
- An automated myringotomy and tube delivery system was employed.
- Anxiolytics, sedation, and papoose boards were intentionally omitted.
- Pain was assessed using the Faces Pain Scale-Revised (FPS-R) in older children.
Main Results:
- Successful tube placement was achieved in 85.8% of children under 5 and 89.2% of children aged 5-12.
- Mean pain scores were 3.30 during placement and 1.69 five minutes post-procedure.
- No serious adverse events were reported.
- Nonserious adverse event rates were comparable to standard procedures.
Conclusions:
- In-office tympanostomy tube placement is technically successful and safe for selected pediatric patients.
- Lidocaine iontophoresis provides adequate local anesthesia, eliminating the need for sedatives or restraints.
- This approach offers a viable alternative for outpatient tympanostomy tube procedures.
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.
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