Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Rationale:
The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug
premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so
coordination between departments and operating room, exposed to the risks of side effects and
failure and this variability action. Alternative means were evaluated, such as the presence
of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.
Electronic tabs are small devices; light, easy to use with age-specific and interactive
programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety
and distract children compare to preoperative medication.
Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10
years old programmed for a short term and low level of pain outpatient surgery. My pass score
will be measured when arriving at the hospital, at the time of the separation with the
parents, at the time of the anaesthetic mask induction and after the surgery.
118 patients will be randomized as follows :
- Arm 1 : Hypnovel® (midazolam)
- Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon
area.