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Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg
C Marechal1,2, J Berthiller3, S Tosetti1
1Department of Anaesthesiology, Hopital Femme Mère Enfant, Bron F-69677, France.
Insights
Tablet game apps (TAB) did not significantly differ from midazolam (MDZ) in reducing children's anxiety during surgery. However, TAB offers a non-pharmacological approach to managing perioperative stress without sedation.
Area of Science:
- Pediatric Anesthesiology
- Child Psychology
- Digital Health Interventions
Background:
- Perioperative anxiety in children is a significant concern, potentially leading to persistent adverse behavioral changes.
- The operating theatre, anesthesia induction, and parental separation are common triggers for pediatric anxiety.
- Current interventions include pharmacological options like midazolam (MDZ), but non-pharmacological alternatives are sought.
Purpose of the Study:
- To compare the efficacy of tablet game applications (TAB) versus midazolam (MDZ) in alleviating anxiety in children undergoing ambulatory surgery.
- To assess anxiety levels during anesthesia induction, parental separation, and post-operative recovery.
- To evaluate the potential of a non-pharmacological intervention for perioperative stress reduction.
Main Methods:
- A randomized controlled trial involving 118 children aged 4-11 years was conducted.
- Participants were allocated to either the tablet game app (TAB) group or the midazolam (MDZ) group.
- Anxiety was measured using the modified Yale Preoperative Anxiety Scale (m-YPAS) at various time points.
Main Results:
- No significant difference in m-YPAS scores was observed between the TAB and MDZ groups at mask induction (P=0.99).
- Anxiety levels did not show significant correlation across the four assessed periods.
- The study included 60 patients in the TAB group and 58 in the MDZ group.
Conclusions:
- Tablet game apps (TAB) were not found to be superior to midazolam (MDZ) in blunting perioperative anxiety in children.
- TAB represents a viable non-pharmacological strategy for reducing perioperative stress.
- This intervention offers potential benefits without causing sedative effects in pediatric patients.
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.
Clinical Trial Registration:
NCT 02192710.
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