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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnovel® (midazolam) | Active Comparator | Midazolam oral intake before anesthesia |
|
| Electronic tab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic tab | Procedure | classic use of an electronic tab with age specific games |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's level of anxiety | Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0) | at day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's level of anxiety | Comparison of m-YPAS score between the 2 arms
| At day 1 |
| Parents' level of anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28100529 | Result | Marechal C, Berthiller J, Tosetti S, Cogniat B, Desombres H, Bouvet L, Kassai B, Chassard D, de Queiroz Siqueira M. Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction. Br J Anaesth. 2017 Feb;118(2):247-253. doi: 10.1093/bja/aew436. |
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| Midazolam oral intake |
| Drug |
|
Evaluation of parents anxiety will be assessed by State-Trait Anxiety Inventory (STAI) :
|
| 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 | 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 | at day 1 |