Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

Study Overview
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Brief Summary
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The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.

Detailed Description
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Perioperative anxiety in children is a common multifactorial influenced and triggered entity with an incidence as high as 50%. Especially (mask)induction of anesthesia is considered one of the most stressful experiences for a child undergoing surgery. A common practice worldwide to diminish the level of anxiety prior to anesthesia is premedication with the benzodiazepine midazolam in order to improve cooperation during induction. Premedication with midazolam has a primary purpose to reduce preoperative anxiety and has inherent to a benzodiazepine its sedative effects. Although these effects are implied, negative effects of premedication: respiratory complications, paradoxical negative behavior has been reported. Although alternative medications have been studied, studies for non-pharmacological anxiety-reduction remain limited. Non-pharmacological anxiety-reduction by distraction including Tablet or IPAD-multimedia might be a readily available alternative for midazolam premedication. Potentially limiting the use of psychoactive agents, limiting the need for preoperative sedation and therefore possibly decrease secondary respiratory complications in pediatric surgical day-care. Objective: The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the mask-induction of anesthesia. Secondly to evaluate the need for midazolam premedication in pediatric day-care surgery patients induced by inhalational anesthesia.

Official Title
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The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial

Conditions
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Perioperative Anxiety, Preanesthetic Medication, Inhalation Anesthesia, Ambulatory Surgery, Tonsillectomy, Circumcision, Dental Care

Intervention / Treatment
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* Drug: Midazolam oral solution
* Device: IPAD


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age ≥ 1 year and <8 years old ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System) Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care Written informed consent by the legal parents or caretaker Exclusion criteria Parents of the patient wish not to participate with the study Parents are not able to give informed consent (language barrier, legally incapable) A contraindication for the use of premedication with midazolam A known allergy to midazolam A contraindication for premedication in general A contraindication for the use of a gas-induction/gas-anesthesia A contraindication for the use of sevoflurane A known mental retardation of the child Preoperative behavioral disturbances and psychiatric disorders Any use of psychoactive medication A known photosensitive epilepsy A previous operation within 3 months of the time of scheduled operation Any other contraindication for the use of the study medication Previous history of multiple surgery (>3)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 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
Interventional Model Description: Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam Group<br>Midazolam(Buccolam 5mg/ml) 0.5mg/kg oral, max 12mg one time given 30 min prior to going to holding | Drug: Midazolam oral solution<br>* Oral Buccolam<br>* Other names: Buccolam;|
| Active Comparator: IPAD group<br>No premedication IPAD when arriving at the holding any games, movies, clips, puzzles | Device: IPAD<br>* Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia<br>* Other names: Handheld multimedia, tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level at induction | Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored prior moment of mask induction (T2) | Directly prior to induction of anesthesia, 20 minutes | 
| Anesthesiologist Satisfaction Induction | Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction | During induction of anesthesia 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level at Daycare | Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored at Daycare (T0) when leaving to holding | Leaving daycare, 10 minutes | 
| Anxiety level at holding | Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored at holding (T1) 10 minutes after arrival | On holding, 20 minutes | 
| Anxiety level at recovery | Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/5 * 100 and therefore a score between 23,3-100 Scored at recovery (T3) 15 minutes after awake | 15 minutes after awake, 30 minutes | 
| Anxiety level Change Daycare vs OR | Measured bij Short version modified Yale Preoperative Anxiety Scale(mYPAS-SF), scoring activity 1-4/4, vocalizations 1-6/6, emotional expressivity 1-4/4, state of apparent arousal 1-4/4, parental use 1-4/4, subtotal is the sum of all the individual scores divided by their number of choices, mYpas-SF total score is subtotal/4 * 100 and therefore a score between 23,3-100 | change during daycare (T0) and induction(T2) in the OR, average 1 hour | 
| Sedation level at Daycare | Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding | 10 minutes | 
| Sedation level at holding | Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding | 20 minutes | 
| Sedation level at induction | Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2) | 10 minutes | 
| Sedation level at recovery | Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3) | 30 minutes | 
| Laryngospasm at induction | Laryngospasm by Four-point scale: No Laryngospasm Mild laryngospasm (relieved by jaw thrust and 100% oxygen), Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation) Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post-induction | 10 minutes | 
| Laryngospasm post extubation/post laryngeal mask | Laryngospasm by Four-point scale: No Laryngospasm Mild laryngospasm (relieved by jaw thrust and 100% oxygen), Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation) Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post detubation/post laryngeal mask | 10 minutes | 
| Bronchospasm postinduction | Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction | 10 minutes | 
| Bronchospasm post detubation/laryngeal mask | Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR post detonation/laryngeal mask | 10 minutes | 
| Postoperative Pain | The pain observation scale for young children (POCIS-Score) score 0-7, scoring 0 or1 for • face-expression: frowning/grimaces = 1, sound crying/moan =1, breathing: irregular/gasping/holding=1, body tonus: tense/shiver/restless =1, movement of arms: tense/fist/restless =1, movement of legs: tense/pulled up/flexed = 1, mood: agitation/restless = 1 Scored on the recovery 30 minutes after arrival | 40 minutes | 
| Parental Satisfaction on the anxiety-management at daycare | Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored at daycare-surgery (T0) | 10 minutes | 
| Parental Satisfaction on the anxiety-management at holding | Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored at holding (T1) | 10 minutes | 
| Parental Satisfaction on the anxiety-management at OR | Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored after induction and parent has left the OR (T2) | 10 minutes | 
| Parental Satisfaction on the anxiety-management at recovery | Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored at the recovery (T3) | 10 minutes | 
| Parental Stress level at day care | Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed scored at day care (T0) | 10 minutes | 
| Parental Stress level at holding | Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed Scored at holding (T1) | 10 minutes | 
| Parental Stress level at OR | Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed Scored at OR (T2) | 10 minutes | 
| Parental Stress level at recovery | Parental Stress level in 5 - point scale- ´I feel': Extremely Stressed Very stressed moderate stressed Low stressed Very low stressed Scored at recovery (T3) | 10 minutes | 
| Overall Parental Satisfaction | 5- Point scale Very satisfied Satisfied Neutral Unsatisfactory Very Unsatisfactory Scored when leaving recovery | 10 minutes | 
| Child Stress level by parent at daycare | Child Stress level by parent, 5- Point scale Happy, plays Slightly worried Worried, stops playing Fears, crying Hysterical Scored at daycare-surgery (T0) | 10 minutes | 
| Child Stress level by parent at holding | Child Stress level by parent, 5- Point scale Happy, plays Slightly worried Worried, stops playing Fears, crying Hysterical Scored at holding (T1) | 10 minutes | 
| Child Stress level by parent at OR | Child Stress level by parent, 5- Point scale happy, plays slightly worried worried, stops playing fear, crying hysterical Scored at OR after induction (T2) | 10 minutes | 
| Child Stress level by parent at Recovery | Child Stress level by parent, 5- Point scale Happy, plays Slightly worried Worried, stops playing Fear, crying Hysterical Scored at recovery (T3) | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preanesthetic medication, Handheld computer, Midazolam, Multimedia, Anxiety, Mask induction, Day Care Surgery