OBJECTIVES: We describe a new iontophoresis solution, used in conjunction with a new iontophoresis system for achieving anesthesia of the tympanic membrane before myringotomy and insertion of pressure equalization tubes in an office setting. METHODS: We selected 50 patients (86 ears) who met standard indications for myringotomy only or myringotomy and pressure equalization tube insertion for a single-site consecutive series trial (Institutional Review Board-approved; informed consent and assent) in the authors' clinical practice. Topical anesthesia was obtained with a new US Food and Drug Administration-cleared iontophoresis system (Acclarent, Inc, Menlo Park, California) and a novel iontophoresis solution mixture. The Wong-Baker FACES Pain Rating Scale was used to assess the tolerability of the iontophoresis system with the new solution and of the otologic procedure after topical anesthesia was obtained. RESULTS: Iontophoresis success was obtained in 78 of 86 ears (90.7%). The average pain score for patients after iontophoresis was 1.07 on a 0-to-5 scale of increasing pain. The ear treatment was successful in 70 of 78 ears (89.7%). The average pain score for the surgical procedure was 1.19. CONCLUSIONS: This study demonstrates the safety and clinical effectiveness of the Acclarent iontophoresis system in conjunction with a new iontophoresis solution for anesthesia of the tympanic membrane in an office setting. This solution and device enable otologic procedures in children as young as 12 months of age without the use of a papoose, premedication, or general anesthesia.
OBJECTIVES: We describe a new iontophoresis solution, used in conjunction with a new iontophoresis system for achieving anesthesia of the tympanic membrane before myringotomy and insertion of pressure equalization tubes in an office setting. METHODS: We selected 50 patients (86 ears) who met standard indications for myringotomy only or myringotomy and pressure equalization tube insertion for a single-site consecutive series trial (Institutional Review Board-approved; informed consent and assent) in the authors' clinical practice. Topical anesthesia was obtained with a new US Food and Drug Administration-cleared iontophoresis system (Acclarent, Inc, Menlo Park, California) and a novel iontophoresis solution mixture. The Wong-Baker FACES Pain Rating Scale was used to assess the tolerability of the iontophoresis system with the new solution and of the otologic procedure after topical anesthesia was obtained. RESULTS: Iontophoresis success was obtained in 78 of 86 ears (90.7%). The average pain score for patients after iontophoresis was 1.07 on a 0-to-5 scale of increasing pain. The ear treatment was successful in 70 of 78 ears (89.7%). The average pain score for the surgical procedure was 1.19. CONCLUSIONS: This study demonstrates the safety and clinical effectiveness of the Acclarent iontophoresis system in conjunction with a new iontophoresis solution for anesthesia of the tympanic membrane in an office setting. This solution and device enable otologic procedures in children as young as 12 months of age without the use of a papoose, premedication, or general anesthesia.
Authors: David M Yen; Michael T Murray; Robert Puchalski; Andrew R Gould; John Ansley; Randall A Ow; Jonathan R Moss; Laura J England; Charles A Syms Journal: OTO Open Date: 2020-02-24