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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
classic use of an electronic tab with age specific games
Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France
Patient's level of anxiety
Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)
Time frame: at day 1
Patient's level of anxiety
Comparison of m-YPAS score between the 2 arms * when arriving at the operating room airlock H-1 before surgery, * at the time of the separation with the parents * 15 minutes before surgery and * 30 minutes before departure from the hospital the same day
Time frame: At day 1
Parents' level of anxiety
Evaluation of parents anxiety will be assessed by State-Trait Anxiety Inventory (STAI) : * when arriving at the operating room airlock H-1 before surgery, * at the time of the separation with the parents * 15 minutes before surgery and * 30 minutes before departure from the hospital the same day
Time frame: At Day 1
Parents' level of anxiety
post-surgery behavioral changes will be measured using the Post Hospitalization Behavioral Questionnaire (PHBQ) at Day+1, day+7 and Day+14 after surgery
Time frame: Up to 2 weeks after Day 1
Satisfaction of patients, parents and medical team
Evaluation of the general satisfaction of children, parents and anesthetic staff will be measured using Visual Analogic Scale (VAS) 30 minutes before departure from the hospital the same day
Time frame: at day 1
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