• Br J Anaesth · Feb 2017

    Randomized Controlled Trial Comparative Study

    Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction.

    • C Marechal, J Berthiller, S Tosetti, B Cogniat, H Desombres, L Bouvet, B Kassai, D Chassard, and M de Queiroz Siqueira.
    • Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.
    • Br J Anaesth. 2017 Feb 1; 118 (2): 247-253.

    BackgroundThe operating theatre, anaesthesia induction and separation from parents create fear and anxiety in children. Anxiety leads to adverse behavioral changes appearing and sometimes persisting during the postoperative period. Our aim was to compare the effects of midazolam (0.3 mg kg-1: MDZ) for premedication with age-appropriate tablet game apps (TAB) on children anxiety during and after ambulatory surgery.MethodsA randomized controlled trial was conducted from May 16th, 2013 to March 25th, 2014 at the Children Hospital of Lyon. The primary outcome of this study was the change in m-YPAS score at the time of anaesthetic mask induction. Anxiety was also assessed in the waiting surgical area, at the time of separation with parents and when back in the ambulatory surgery ward.ResultsOne hundred and eighteen patients aged four-11 yr were recruited, 60 in the TAB Group and 58 in the MDZ Group. Main endpoint was missing for three patients from the MDZ Group. At the time of mask induction, there was no significant difference between MDZ and TAB Group for the m-YPAS score (40.5 (18.6) vs 41.8 (20.7), P = 0.99). There was no significant correlation between m-YPAS score and its evolution over the four period of time between subjects.ConclusionsWe were not able to show whether TAB is superior to MDZ to blunt anxiety in children undergoing ambulatory surgery. TAB is a non-pharmacological tool which has the capacity in reducing perioperative stress without any sedative effect in this population.Clinical Trial RegistrationNCT 02192710.© The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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