Department of Otolaryngology - Head and Neck Surgery, Columbia University Medical Center, New York, New York, U.S.A.
Advanced ENT and Allergy, Louisville, Kentucky, U.S.A.
Laryngoscope. 2020 May;130 Suppl 4(Suppl 4):S1-S9. doi: 10.1002/lary.28612. Epub 2020 Mar 11.
OBJECTIVES/HYPOTHESIS: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.
Prospective individual cohort study.
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).
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.
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.
2b Laryngoscope, 130:S1-S9, 2020.
目的/假设：评估利多卡因离子电渗疗法和鼓膜切开术管放置在办公室环境中的儿童的技术成功率、耐受性和安全性。
前瞻性个体队列研究。
这项前瞻性多中心研究评估了 6 个月至 12 岁儿童在办公室进行的管放置。通过利多卡因/肾上腺素离子电渗疗法实现麻醉。使用集成和自动化鼓膜切开术和管输送系统进行管放置。未使用镇静剂、镇静剂和襁褓板。评估技术成功率和安全性。5 至 12 岁的患者使用面部疼痛量表修订版（FPS-R）仪器自我报告管放置疼痛，范围从 0（无痛）到 10（非常疼痛）。
儿童被纳入三个队列，手术室（OR）先导、办公室先导和关键队列中分别有 68、47 和 222 名儿童。在关键队列中，<5 岁和 5-12 岁年龄组分别有 120 和 102 名儿童，平均年龄分别为 2.3 和 7.6 岁。94.2%的<5 岁儿童和 88.2%的 5-12 岁儿童双侧均需置管。85.8%（103/120）的<5 岁儿童和 89.2%（91/102）的 5-12 岁儿童所有指示耳朵均成功放置了管。管放置的平均 FPS-R 评分为 3.30（标准差[SD]=3.39），术后 5 分钟评分为 1.69（SD=2.43）。无严重不良事件。非严重不良事件发生率与标准鼓膜切开术相似。
通过利多卡因离子电渗局部麻醉和自动化鼓膜切开术和管输送系统，无需镇静剂、镇静剂或襁褓约束，可在选定患者中成功完成办公室置管。
2b 喉镜，130：S1-S9，2020 年。
