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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004671-39 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam Group | Active Comparator |
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| IPAD group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam oral solution | Drug | Oral Buccolam |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative need for pain medication | Postoperative need for pain medication, indicated as yes or no, and description of medication with given dose Noted on the recovery | 1 hour |
| Postoperative need for anti-nausea/vomiting medication |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Van Hoorn, MD | Contact | +32468187852 | Alex.VanHoorn@uzbrussel.be | |
| Panagiotis Flamée, MD | Contact | +3224773143 | Panagiotis.Flamee@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Alex Van Hoorn, MD | Resident of department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel (UZ Brussel) | Recruiting | Jette | 1090 | Belgium |
Available 3 months after study publication for 10 years
Written request and providing a methodological proposal
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication
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digital block randomization
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| IPAD | Device | Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia |
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| 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:
| 10 minutes |
| Laryngospasm post extubation/post laryngeal mask | Laryngospasm by Four-point scale:
| 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 |
| 10 minutes |
| Parental Satisfaction on the anxiety-management at holding |
| 10 minutes |
| Parental Satisfaction on the anxiety-management at OR |
| 10 minutes |
| Parental Satisfaction on the anxiety-management at recovery |
| 10 minutes |
| Parental Stress level at day care | Parental Stress level in 5 - point scale- ´I feel':
| 10 minutes |
| Parental Stress level at holding | Parental Stress level in 5 - point scale- ´I feel':
| 10 minutes |
| Parental Stress level at OR | Parental Stress level in 5 - point scale- ´I feel':
| 10 minutes |
| Parental Stress level at recovery | Parental Stress level in 5 - point scale- ´I feel':
| 10 minutes |
| Overall Parental Satisfaction | 5- Point scale
| 10 minutes |
| Child Stress level by parent at daycare | Child Stress level by parent, 5- Point scale
| 10 minutes |
| Child Stress level by parent at holding | Child Stress level by parent, 5- Point scale
| 10 minutes |
| Child Stress level by parent at OR | Child Stress level by parent, 5- Point scale
| 10 minutes |
| Child Stress level by parent at Recovery | Child Stress level by parent, 5- Point scale
| 10 minutes |
Postoperative need for anti-nausea/vomiting medication, indicated as yes or no, and description of product with given dose Noted on the recovery
| 1 hour |
| Time arrival recovery to time leaving recovery | Time arrival recovery to time leaving recovery, time notation on arrival and leaving Noted on the recovery | 2 hour |
| D006571 | Heterocyclic Compounds |