{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T15:18:03Z","timestamp":1777562283820,"version":"3.51.4"},"reference-count":35,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,11,20]],"date-time":"2024-11-20T00:00:00Z","timestamp":1732060800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Preceptis Medical, Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ear Nose Throat J"],"abstract":"<jats:p>Objective: In-office tympanostomy tube insertion (TTI) is becoming more available in the practice of pediatric otolaryngology. This study evaluated the tolerability of this procedure in young children. Method: Four methods were used to assess tolerability. (1) Standardized video recordings were collected from 30 patients under 24 months who underwent in-office TTI with a single-pass insertion device with topical anesthesia alone. The videos were then reviewed by 3 independent experts in pediatric care and rated at 5 procedural time points using a defined response scale developed with the U.S. Food and Drug Administration. (2) Separately, overall tolerability was subjectively assessed by the same experts. (3) Patient recovery was assessed by the participating otolaryngologist and support staff. (4) Patient caregivers were surveyed for their impressions of the procedure, including whether they would recommend it to other caregivers. Results: In a total of 90 reviews, 100% of children were successfully treated and were rated as having acceptably tolerated the in-office tympanostomy tube procedure. All patients returned to an acceptable baseline without inappropriate crying and were assessed as fully recovered immediately following the procedure or by the time the child was leaving clinic. For caregivers, 93% agreed or strongly agreed that they would recommend the use of in-office TTI to other caregivers. Conclusions: In-office TTI in young children was determined to be universally well tolerated in young children and is a procedure that patient caregivers would recommend to other caregivers for their children. These results should help reassure otolaryngology specialists and caregivers alike that in-office ear tube placement is a viable option for young children with middle ear disease.<\/jats:p>","DOI":"10.1177\/01455613241300890","type":"journal-article","created":{"date-parts":[[2024,11,20]],"date-time":"2024-11-20T23:35:21Z","timestamp":1732145721000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Assessment of In-Office Tympanostomy Tube Insertion Tolerability in Children Under 2 Years"],"prefix":"10.1177","author":[{"given":"Shelagh A.","family":"Cofer","sequence":"first","affiliation":[{"name":"Department of Head and Neck Surgery, Mayo Clinic, Rochester, MN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph N.","family":"Badaoui","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Maryland, College Park, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5415-8941","authenticated-orcid":false,"given":"Frank","family":"Rimell","sequence":"additional","affiliation":[{"name":"Pediatric Otolaryngology, Children\u2019s Hospital of Southwest Florida, Fort Myers, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grace","family":"Nimmons","sequence":"additional","affiliation":[{"name":"Otolaryngology Head and Neck Surgery, Health Partners Park Nicollet, St. Louis Park, MN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Raisen","sequence":"additional","affiliation":[{"name":"Prairie Sinus Ear Allergy Clinic, Bismarck, ND, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"Tombers","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery, Mayo Clinic, Rochester, MN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theodore O.","family":"Truitt","sequence":"additional","affiliation":[{"name":"Otolaryngology Head and Neck Surgery, St. Cloud ENT, St. Cloud, MN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,11,20]]},"reference":[{"issue":"11","key":"bibr1-01455613241300890","first-page":"1","author":"Cullen KA","year":"2009","journal-title":"Natl Health Stat Report"},{"key":"bibr2-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1177\/0194599816636102"},{"key":"bibr3-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2015.09.041"},{"key":"bibr4-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1177\/0194599815608366"},{"key":"bibr5-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1002\/lio2.533"},{"key":"bibr6-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1002\/lary.28612"},{"key":"bibr7-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2015.11.003"},{"key":"bibr8-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2023.111772"},{"key":"bibr9-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.128.9.1040"},{"key":"bibr10-01455613241300890","doi-asserted-by":"publisher","DOI":"10.1038\/npp.2014.134"},{"key":"bibr11-01455613241300890","unstructured":"FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. 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