“Kids these days. They just don’t get scared like they used to.” – Henry J Waternoose III (Monsters Inc.)
Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg/kg midazolam to tablet computer based interactive distraction. Marechal et al. Br J Anaesth (2017) 118 (2): 247-253. DOI: https://doi.org/10.1093/bja/aew436
This was a single centre, partially blinded, prospective randomised control trial looking at the effects of midazolam (0.3 mg/kg: MDZ) for premedication with age-appropriate tablet game applications (TAB) on children’s anxiety during and after ambulatory surgery.
The study was carried out in a tertiary paediatric centre in Lyon between May 2013 and March 2015. One hundred and eigthenn patients were recruited and randomly allocated to the MDZ and TAB arm of the trial.
The MDZ group received 0.3 mg/kg of midazolam via the oral or rectal route 20-30 minutes prior to anaesthesia. The TAB group received an iPad 20 minutes prior to anaesthesia with age appropriate applications to chose from.
The primary outcome looked at the modified Yale preoperative anxiety score (mYPAS) at mask induction after each intervention. Secondary outcomes included measuring anxiety levels: upon arrival to the ambulatory ward, at separation from parents, on return back to the ambulatory ward, parental anxiety, children’s post operative behaviour changes at home, satisfaction of parents/ children/ staff.
No significant difference of scores was found between the two groups, with a p value of 0.99. The mean mYPAS in MDZ group was 40.5 whereas the mean mYPAS in the tablet group was 41.8.
- The study was fairly well represented with respect to gender, age and surgical speciality.
- Aside from the intervention, each group was treated equally.
Weaknesses: There were a number of limitations in the design of the study.
- It was partially blinded, the children, parents and nursing staff were aware of which intervention group they had been allocated to.
- The mYPAS score was modified for the study which may have decreased the validity of the scoring system.
- No baseline anxiety levels were recorded and the children were poorly followed up.
- The dose of midazolam was under dosed for the routes given.
- In this study parents left before induction, this is not representative of anaesthesia in the UK whereby parents stay until the child is anaesthetised.
- The children were also anaesthetised in theatre compared to the UK where anaesthetic rooms are common practice.
Overall, this study was poorly designed and concluded there was no difference in anxiety levels between the two interventions. It is unlikely that a further trial would influence our current practice.