Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial.

INTRODUCTION: Perioperative anxiety is a common and undesirable outcome in pediatric surgical patients. The use of interactive tools to minimize perioperative anxiety is vastly understudied. The main objective of the current investigation was to compare the effects of a tablet-based interactive distraction (TBID) tool to oral midazolam on perioperative anxiety. We hypothesized that the TBID tool was not inferior to midazolam to reduce perioperative anxiety.
METHODS: 108 children, ages 1-11 years, presenting for outpatient surgical procedures were prospectively randomized to oral midazolam (0.5 mg·kg(-1); 20 mg max) or TBID. The primary outcome was the change in anxiety level from baseline to parental separation and anesthetic induction. Other data collected included emergence delirium, parental satisfaction, time-to-PACU discharge, and posthospitalization behavior.
RESULTS: The mean difference (95% CI) in the increase of anxiety at parental separation between the TBID and the midazolam group was -9 (-2.6 to -16.4), P = 0.006, demonstrating superiority to midazolam group (one-sided P = 0.003). For children 2-11 years, the mean difference (95% CI) in anxiety at induction was significant between the TBID and midazolam groups, -14.0 (-6.1 to -22.0), P < 0.001. The median (IQR) time-to-PACU discharge was 111 (75-197) min in the midazolam group and 87 (55-137) min in the TBID group, P = 0.03. Decreased emergence delirium and increased parental satisfaction were also observed in the TBID group.
CONCLUSIONS: A TBID tool reduces perioperative anxiety, emergence delirium, and time-to-discharge and increases parental satisfaction when compared to midazolam in pediatric patients undergoing ambulatory surgery.

RCT Entities:   Population Interventions Outcomes