Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children

Study Overview
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Brief Summary
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preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders. to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet. the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery

Detailed Description
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this study is a prospective,randomized, active treatment controlled trial.It enrolls 100 children . after written and informed consent,the study participants were randomly assigned using a computer generated table to one of two treatment groups prior to elective surgery. Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes before the parental separation and until the anesthesia induction Group MD:will receive oral midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of parents,the admission in the operating room and the anesthesia induction. Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence of Delirium) and parental satisfaction were also assessed.

Official Title
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Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children

Conditions
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Anxiety

Intervention / Treatment
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* Procedure: elective surgery
* Drug: Midazolam
* Device: Interactive Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-10 years old children elective surgery ASA PS I/II Exclusion Criteria: Parental refusal Emergency procedure Behavioral or psychiatric disorders allergy or hypersensitivity to midazolam

Ages Eligible for Study
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Minimum Age: 3 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group tablet<br>group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction | Procedure: elective surgery<br>* investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery<br>* Other names: we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction;Device: Interactive Tablet<br>* interactive Tablet containing many cartoon's videos<br>|
| Active Comparator: Group Midazolam<br>group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation | Procedure: elective surgery<br>* investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery<br>* Other names: we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction;Drug: Midazolam<br>* Oral Midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale (MYPAS)at different time prior to elective surgery .the averaged score range from 24.9: no anxiety to 100 very anxious | 20 minutes after tablet was given | 
| Preoperative anxiety | preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery .the averaged score ranges from 24.9 no anxiety to 100 very anxious | 25 minutes after tablet was given | 
| Preoperative anxiety | preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery.the averaged score range from 24.9 no anxiety to 100 very anxious | 30 minutes after tablet was given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the acceptance of Facial mask | the acceptance of facial mask by an established score | 30 minutes after tablet was given | 
| post operative agitation | post operative agitation was assessed using PAEDS which was calculated 10 to 15 minutes after the anesthetic wake up. | 10 to 15 minutes after wakeup of anesthesia | 
| the parental satisfaction | by an established score | 1 hour after the wake up of anesthesia |