Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam

Study Overview
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Brief Summary
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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 : Arm 1 : Hypnovel® (midazolam) Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon area.

Official Title
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Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam

Conditions
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Paediatric Outpatient Surgery

Intervention / Treatment
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* Procedure: electronic tab
* Drug: Midazolam oral intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Girls and boys aged 4 to 10 years, American Society of Anesthesiologists Score between 1 and 3, programmed outpatient surgery for a short term and low level of pain Infection with influenza A virus confirmed with a quick diagnostic test, informed consent from both parents Exclusion Criteria: patients younger than 4 or older than 10 years old preexisting psychiatric disorder with pedo-psychiatric follow-up children with intellectual disability psychotropic referred to anxiolytic and / or antipsychotic history of surgery (n>=3) refusal to participate

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypnovel® (midazolam)<br>Midazolam oral intake before anesthesia | Drug: Midazolam oral intake<br> <br> |
| Experimental: Electronic tab<br> | Procedure: electronic tab<br>* classic use of an electronic tab with age specific games<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outpatient surgery, anaesthesia, midazolam, electronic tab