Split-thickness skin graft survival was significantly improved by the use of NPDs. Because the use of NPDs is expensive, we consider their use only in patients with potential wound-healing problems, when there is a need to monitor the hand, or when immediate postoperative hand immobilization might impede the patient's recovery.
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
As a cell surface expressed protein that promotes tumor growth and high expression in head and neck squamous cell carcinoma but not in normal tissue, EMMPRIN may be a good target for directed molecular therapy.
ObjectiveEvaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office.Study DesignProspective, single‐arm.SettingEighteen otolaryngology practices.MethodsChildren 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.ResultsTubes 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.ConclusionIn‐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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