Rimell, Franklin L.

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.

Importance: Phenol kits cleared by the Food and Drug Administration (FDA) are indicated as a topical anesthetic for the tympanic membrane (TM) in adults. However, there is no existing literature that reports outcomes to support the safety and use of phenol on the TM of awake children. Objective: Determine if topical phenol is safe and at low risk for complications and therefore be used effectively in awake children to facilitate office otologic procedures as in adults. Design, Setting, and Participants: Children under 21 years of age whose parents agreed to participate in an awake office setting for tympanostomy tube (TT) placement. All children had TT placement after phenol placement on the TM prior to insertion. Main Outcomes and Measures: TM perforation or other signs of TM complications through a minimum of 6-month clinical follow-up, along with assessment of the tolerability of the procedure by the child. Results: A total of 228 children with an age range of 6 months to 15.9 years and 435 TMs completed TT placement using phenol as a local anesthetic while awake in the office. There were no complications reported in the 204 children at the first follow-up visit post TM placement within 3 to 10 weeks. Of the 93 children followed up at least 6 months, there were no TM complications reported. Conclusions: This is the first study to report the outcomes on the use of phenol in an office setting in children. In this large experience, phenol appears to be tolerable and safe for use in young children in the office and is a potential safe choice of topical anesthesia for surgeons if they choose to perform office procedures such as myringotomies or TT placement on children.