title: 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.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  One 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.
  
  
  CONCLUSIONS
  We 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.
  
  
  BACKGROUND
  NCT 02192710.
authors.affiliation: Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.|University Lyon 1, Lyon F-69000, France.
authors.forename: C
authors.initials: C
authors.lastname: Marechal
authors.affiliation: Service de Pharmacologie Clinique, EPICIME-CIC 1407 de Lyon, Inserm, CHU-Lyon, Bron F-69677, France.
authors.forename: J
authors.initials: J
authors.lastname: Berthiller
authors.affiliation: Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.
authors.forename: S
authors.initials: S
authors.lastname: Tosetti
authors.affiliation: Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.
authors.forename: B
authors.initials: B
authors.lastname: Cogniat
authors.affiliation: Department of Child and Adolescent Psychiatry, Hopital Femme Mère Enfant, Bron F-69677, France.|University Lyon 1, Lyon F-69000, France.
authors.forename: H
authors.initials: H
authors.lastname: Desombres
authors.affiliation: Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.|University Lyon 1, Lyon F-69000, France.
authors.forename: L
authors.initials: L
authors.lastname: Bouvet
authors.affiliation: University Lyon 1, Lyon F-69000, France.|Service de Pharmacologie Clinique, EPICIME-CIC 1407 de Lyon, Inserm, CHU-Lyon, Bron F-69677, France.
authors.forename: B
authors.initials: B
authors.lastname: Kassai
authors.affiliation: Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France dominique.chassard@chu-lyon.fr.|University Lyon 1, Lyon F-69000, France.
authors.forename: D
authors.initials: D
authors.lastname: Chassard
authors.affiliation: Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.
authors.forename: M
authors.initials: M
authors.lastname: de Queiroz Siqueira
mesh_terms: D000556:Ambulatory Surgical Procedures; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D034201:Computers, Handheld; D005260:Female; D006801:Humans; D008297:Male; D008874:Midazolam / Q000627:therapeutic use*; D010290:Parents / Q000523:psychology*; D011229:Preanesthetic Medication; D018910:Video Games
chemical_list: D014151:Anti-Anxiety Agents; D008874:Midazolam
keywords: ambulatory surgical procedures; child; premedication