Beyond emotional and behavioral issues, there can be complications with general anesthesia in pediatric patients, even with the brief anesthetic exposure required for a tympanostomy procedure, especially in young children (Ing et al., 2014 Wang et al., 2014 Zhang et al., 2015). In addition, following elective outpatient surgery, data indicate that children can experience short-term behavioral problems, such as post-surgical emergence delirium, sleep problems, and eating disturbances (Kain et al., 2006 Mason, 2017). Unfortunately, most children as well as their parents have high distress associated with anesthesia (Chorney & Kain, 2009 Davidson & McKenzie, 2011 Fortier et al., 2010 Kain et al., 1999). This surgery is typically brief and uncomplicated given the extreme sensitivity of the eardrum and the mobility of young children, general anesthesia is employed. The procedure involves making an incision in the tympanic membrane (TM) and inserting a tube to maintain ventilation and prevent recurrence of fluid. Myringotomy and tympanostomy tube placement for recurrent acute otitis media or chronic otitis media with effusion is the most common ambulatory pediatric surgical procedure in the USA, accounting for 24% of all pediatric (0–15 years of age) ambulatory surgeries (Hall et al., 2017). These data suggest that pediatric tympanostomy and tube placement can be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. FLACC scores were inversely correlated with age, with older children displaying lower distress. Mean FLACC score 3-min post-tube placement was 1.3 for children ages 6 months to 4 years and was 0.2 for children age 5–12 years. Mean tube placement FLACC score was 4.0 (out of a maximum score of 10) for children ages 6 months to 4 years and was 0.4 for children age 5–12 years. Mean FPS-R score for tube placement was 3.30, in the “mild’ pain range, and decreased to 1.69 at 5-min post-procedure. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children’s distress. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children ages 5 through 12 years. Anxiolytics, sedation, or papoose board were not used. Behavioral strategies were used to minimize procedural distress. The in-office tube placement procedure included local anesthesia via lidocaine/epinephrine iontophoresis and tube placement using an integrated and automated myringotomy and tube delivery system. The cohort included 14% Hispanic or Latinx, 84.2% White, 12.6% Black, 1.8% Asian and 4.1% ‘Other’ race and ethnicity classifications. Mean age of children was 4.7 years old (SD = 3.18 years), with more boys (58.1%) than girls (41.9%). 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. The purpose of this study was to evaluate behavioral strategies to minimize procedural distress associated with in-office tympanostomy tube placement for children without general anesthesia, sedation, or papoose-board restraints.
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