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
Presented by Dr R. Morris-Clarke
- 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
- Children aged 4-10 years
- ASA 1-3
- Pre-operative behavioural disturbances
- Psychiatric medication
- Previous history of multiple surgeries (>3)
- 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
- 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
- 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
- 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:
- Kids wanted a tablet when they got home
- Elective cases only
- Low dose of midazolam
- ‘Fun’ study that has the potential to benefit patients via non-pharmacological methods
- Use of several common statistical tests
- Prospective randomized trial
- 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