RESUMEN
BACKGROUND: Pre-operative anxiety occurs in 18 to 60% of children undergoing surgery and results in poor outcomes. Nonpharmacological methods of distraction are effective in alleviating peri-operative anxiety. In our institution, ride-on electric cars (ride-on e-cars) are routinely used by children undergoing ambulatory surgery as a mean of nonpharmacological distraction. OBJECTIVES: The aim of this study is to assess the effect of pre-operative distraction with ride-on e-cars on children's pre-operative anxiety when undergoing elective ambulatory surgery. DESIGN: This was a prospective, randomised, controlled, open-label study. SETTING: The study was carried out from September 2019 to September 2021 in the ambulatory paediatric surgery unit of our teaching hospital, in Marseille, France. PATIENTS: Children aged 2 to 10âyears and weighing less than 35âkg undergoing elective ambulatory surgery were eligible. One hundred and fifteen children were included, 56 in the control group and 59 in the intervention group. INTERVENTION: Children in the control group were transported from the operating room (OR) waiting area to the OR using a trolley, while children in the intervention group used the ride-on e-cars, without pharmacological premedication or parental presence. MAIN OUTCOME MEASURES: The primary outcome was pre-operative anxiety at the end of the transport (prior going into the OR assessed by the modified Yale Preoperative Anxiety Score Short Form (mYPAS-SF). Secondary outcomes were the anxiety levels in children over time, as well as postoperative pain and agitation assessed with the Face Legs Activity Cry Consolability (FLACC) and Paediatric Anaesthesia Emergence Delirium (PAED) scales, respectively. RESULTS: The mYPAS-SF anxiety scores did not differ between the control group and the intervention group (39â±â19 vs. 37â±â21, P â=â0.574). The secondary outcomes were similar between the two groups. CONCLUSIONS: Our randomised controlled trial showed that the use of ride-on e-cars did not alter pre-operative anxiety as compared with standard transport in children undergoing elective ambulatory surgery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03961581.