Behavioral Strategies to Minimize Procedural Distress During In-Office Pediatric Tympanostomy Tube Placement Without Sedation or Restraint

Abstract

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. 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. Mean age of children was 4.7 years old (SD = 3.18 years), with more boys (58.1%) than girls (41.9%). The cohort included 14% Hispanic or Latinx, 84.2% White, 12.6% Black, 1.8% Asian and 4.1% ‘Other’ race and ethnicity classifications. 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. Behavioral strategies were used to minimize procedural distress. Anxiolytics, sedation, or papoose board were not used. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children ages 5 through 12 years. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children’s distress. 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. 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 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. FLACC scores were inversely correlated with age, with older children displaying lower distress. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. These data suggest that pediatric tympanostomy and tube placement can be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints.

Comparison of Tympanostomy Tubes Under Local Anesthesia Versus General Anesthesia for Children

“…Unfortunately, due to limited resources, child life specialists were rarely present during the under LA, which would likely improve the overall experience. It has been demonstrated that parental presence, the use of neutral language, a calm attitude, and information about procedural steps reduce children's anxiety 25 . However, in our study, parental presence has not been associated with a decrease in pain scores.…”

“…It has been demonstrated that parental presence, the use of neutral language, a calm attitude, and information about procedural steps reduce children's anxiety. 25 However, in our study, parental presence has not been associated with a decrease in pain scores. Music can also reduce anxiety and pain for some children undergoing clinical procedures, 26 but has not influenced our results.…”

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review

“…The evolution of national guidelines, standardized definitions of the depth of sedation and outcomes, and the application of non-pharmacologic techniques have further contributed to reducing the risk of significant adverse events [17]. Once common practices such as immobilization through papoosing (physically restraining a child to keep children still during the medical procedure) have almost universally been replaced with distraction techniques that range from the rudimentary (a book) to the more sophisticated (tablet) [18].…”

Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System

“…A system of technologies (Tula® System; Smith & Nephew) was designed consisting of iontophoresis for the administration of a local anesthetic (2% lidocaine/1:100,000 epinephrine; TYMBION™; Smith & Nephew) to the tympanic membrane (TM), and automated tube delivery that integrates myringotomy and tube placement. Clinical research established the safety, efficacy, and tolerability of this system for in‐office procedures in children, 18‐20 and its use has been further supported in adults 21 . The Tula System was granted breakthrough designation and received US Food and Drug Administration (FDA) approval in 2019 for in‐office tympanostomy in children ages 6 months and older and adult patients.…”