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

British Journal of Anaesthesia 2017;118(2):247-253

doi:10.1093/bja/aew436

Presented by Dr R. Morris-Clarke

Background

  • Having an operation is a stressful time for both parents and children
  • Induction of anaesthesia and parent separation creates fear and anxiety
  • May lead to post operative adverse behavioral changes
  • Midazolam and distraction techniques pre-operatively are common place
  • Premedication associated with unwanted side effects
  • Distraction techniques time consuming but cost effective
  • Previous study – children aged 1-11 given a computer tablet for distraction and showed an effective decrease anxiety

Design and Setting

  • Children’s Hospital of the University of Lyon, France
  • Patients admitted to the ambulatory surgical ward – elective
  • 16th May 2013 – 25th March 2014
  • Informed written consent from Parents and assent for children ages 7+
  • Patients randomized via computer programme to:
    • Midazolam 0.3mg/kg PO or PR 20-30 mins prior to anaesthesia
    • IPAD 20 mins prior to anaesthesia
  • Groups kept separate from each other
  • Primary aim – compare the impact of midazolam vs IPAD at mask induction (time 3)
  • Other aims
  • Anxiety measured on arrival to ward (time 1) at separation from parents (time 2) and once back on ward (time 4)
  • Also recorded post operative behavioral changes at home and parent’s overall satisfaction
  • Child anxiety measured by modified Yale pre-anxiety score (mYPAS)
  • 27 items incl. activity, arousal, vocalization, use of parents, emotional state
  • >30 defined anxiety; >40 high anxiety
  • Parent anxiety – State trait anxiety inventory (STAI), higher scores indicate high anxiety
  • Post hospital behavior questionnaire

Subjects

  1. Children aged 4-10 years
  2. ASA 1-3

Exclusions:

  • Pre-operative behavioural disturbances
  • Psychiatric medication
  • Previous history of multiple surgeries (>3)

Interventions

  • Patients assessed on ward (time 1)
  • Patients assessed with parents on arrival to surgical waiting area (time 2)
  • At Gas induction (time 3)
    • Allowed to carry on playing with IPAD
    • Anaesthesia maintained with sevoflurane
    • GA+/- LA
    • Kept in recovery until no PONV, fully awake, low pain scores
  • Assessed again back on ward (time 4)
  • At home assessments made over the phone at day 1, 7, 14

Outcomes

  • Primary outcome difference between the two group mYPAS scores at gas induction
  • For a power 80% and p<0.05 – 53 patients need in each arm
  • Qualitative and quantitative data was collected and analyzed according to normal distribution fishers exact/x2 test or Wilcoxon nonparametric test as appropriate
  • Statistical analysis was conducted using SAS

Results

  • 118 patients recruited and randomized
  • 60 in IPAD group
  • 58 in Midazolam
    • 3 not included (2 did not receive midazolam and 1 had no mYPAS data)
  • Time 3 (main aim – at gas induction) showed no difference between the two groups
  • 5 vs 41.8
  • Time 2 (assessment of patients in surgical wiaitng area) no difference STAI or mPAS
  • Overall mean mYPAS score less in IPAD group
  • Parents and nurses more satisfied with IPAD
  • Only 40% response rate postoperatively

Conclusions

  • No significant difference to anxiety levels in both groups – either equally good or equally bad. (not previous score of high anxiety was 40 and both groups achieved a mean greater than that.
  • Parents and nurses more satisfied with IPAD – they reported if felt more normal than seeing a semiconscious child
  • Previous trials that had shown a difference between the two did not use a psychiatrist to measure the scores and used different child ages – interpretation bias and someone not accustomed to the questionnaire creating the scores.
  • Low response rate post-operative meant no further conclusions could be drawn

Suggested problems by the authors:

  1. Kids wanted a tablet when they got home
  2. Underpowered
  3. Elective cases only
  4. Low dose of midazolam

Strengths

  • ‘Fun’ study that has the potential to benefit patients via non-pharmacological methods
  • Use of several common statistical tests
  • Prospective randomized trial

Weaknesses

  • No control group i.e. with no intervention
  • iPad 20 minutes before anaesthesia – could the child be bored of it by then?
  • ‘One size fits all’ approach – ipad is a distraction technique but one technique may not suit every child.
  • Why was this published in the BJA and not a French journal. Yet it is being reported in the mainstream media as a positive outcome?
  • How were patients selected? This is not stated. 118 patients of the period of 10 months at a children’s hospital seems a low number.
  • Not blinded – difficult to do.
  • Based on 1 previous positive study
  • Various types of surgery used which may cause different anxiety for different reasons other than anaethesia i.e. cosmetic pinnaplasty
  • Both equally effective or equally ineffective? Who can tell in the end.

Implications/Potential for impact

  • In the elective setting is midazolam appropriate? Post operative drowsiness delaying discharge times.
  • The study implied that the use was normal – everyone?
  • Lead on to further studies regarding distraction versus medication
  • Ultimately will vary anesthetist to anaesthetist and patient to patient