Truitt, Theodore O.

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.

Abstract Objectives Insertion of tympanostomy tubes (TT) is generally accomplished in children in the operating room under general anesthesia. We report on 229 children treated in‐office with a novel device. Methods Investigators participated in an IRB‐approved, prospective, single arm, multisite investigation of in‐office TT placement in awake children. Topical anesthetic was applied, and protective restraint was used. TT placement was performed with a single‐pass TT insertion device. Safety was assessed by monitoring procedural events. Results Four hundred and forty‐four ears were treated in 229 children at 10 sites. Children were in age groups 6‐24 months (n = 211, mean = 13 months) and 5‐12 years (n = 18, mean = 8.3 years). Two hundred and fifteen children received bilateral TT placement, and 14 received unilateral placement. Overall, 226/229 (98.7%) children had successful TT placement in the office (209/211 in 6‐24 months and 17/18 in 5‐12 years). Three children were rescheduled for the operating room due to anatomical challenges or patient movement. Median procedure time for bilateral cases in both age groups was 4:53. Two minor adverse events (AEs) were reported in one patient. Per independent assessment of 30 procedure videos by clinicians, TT placement was tolerated acceptably by all children. Conclusion In‐office TT placement in awake young children using topical anesthetic, enabled by a single pass delivery device, was safe, successful and well tolerated. The American Academy of Otolaryngology (AAO) recently released a Position Statement supporting in‐office TT placement in appropriate children. These results affirm an in‐office alternative for clinicians and parents who have concerns with the risk, inconvenience and cost of surgery in an operating room under general anesthesia. Level of Evidence: 2c. Clinical Trials Registration Number: NCT03544138.