A Phase 4 interventional study of Midazolam oral solution and IPAD in Perioperative Anxiety, Preanesthetic Medication and Inhalation Anesthesia, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2021-05-04.
Sponsored by Universitair Ziekenhuis Brussel · Phase 4, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
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Exclusion criteria
* Midazolam(Buccolam 5mg/ml) * 0.5mg/kg oral, max 12mg * one time * given 30 min prior to going to holding
Drug: Midazolam oral solution
* No premedication * IPAD when arriving at the holding * any games, movies, clips, puzzles
Device: IPAD
Oral Buccolam
Also known as: Buccolam
Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia
Also known as: Handheld multimedia, tablet
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)
Time frame: 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
Time frame: During induction of anesthesia 10 minutes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 minutes
Sedation level at holding
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding
Time frame: 20 minutes
Sedation level at induction
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)
Time frame: 10 minutes
Sedation level at recovery
Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)
Time frame: 30 minutes
Laryngospasm at induction
Laryngospasm by Four-point scale: 1. No Laryngospasm 2. Mild laryngospasm (relieved by jaw thrust and 100% oxygen), 3. Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation) 4. Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post-induction
Time frame: 10 minutes
Laryngospasm post extubation/post laryngeal mask
Laryngospasm by Four-point scale: 1. No Laryngospasm 2. Mild laryngospasm (relieved by jaw thrust and 100% oxygen), 3. Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation) 4. Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post detubation/post laryngeal mask
Time frame: 10 minutes
Bronchospasm postinduction
Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction
Time frame: 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
Time frame: 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
Time frame: 40 minutes
Parental Satisfaction on the anxiety-management at daycare
1. Very satisfied 2. Satisfied 3. Neutral 4. Unsatisfactory 5. Very Unsatisfactory Scored at daycare-surgery (T0)
Time frame: 10 minutes
Parental Satisfaction on the anxiety-management at holding
1. Very satisfied 2. Satisfied 3. Neutral 4. Unsatisfactory 5. Very Unsatisfactory Scored at holding (T1)
Time frame: 10 minutes
Parental Satisfaction on the anxiety-management at OR
1. Very satisfied 2. Satisfied 3. Neutral 4. Unsatisfactory 5. Very Unsatisfactory Scored after induction and parent has left the OR (T2)
Time frame: 10 minutes
Parental Satisfaction on the anxiety-management at recovery
1. Very satisfied 2. Satisfied 3. Neutral 4. Unsatisfactory 5. Very Unsatisfactory Scored at the recovery (T3)
Time frame: 10 minutes
Parental Stress level at day care
Parental Stress level in 5 - point scale- ´I feel': 1. Extremely Stressed 2. Very stressed 3. moderate stressed 4. Low stressed 5. Very low stressed scored at day care (T0)
Time frame: 10 minutes
Parental Stress level at holding
Parental Stress level in 5 - point scale- ´I feel': 1. Extremely Stressed 2. Very stressed 3. moderate stressed 4. Low stressed 5. Very low stressed Scored at holding (T1)
Time frame: 10 minutes
Parental Stress level at OR
Parental Stress level in 5 - point scale- ´I feel': 1. Extremely Stressed 2. Very stressed 3. moderate stressed 4. Low stressed 5. Very low stressed Scored at OR (T2)
Time frame: 10 minutes
Parental Stress level at recovery
Parental Stress level in 5 - point scale- ´I feel': 1. Extremely Stressed 2. Very stressed 3. moderate stressed 4. Low stressed 5. Very low stressed Scored at recovery (T3)
Time frame: 10 minutes
Overall Parental Satisfaction
5- Point scale 1. Very satisfied 2. Satisfied 3. Neutral 4. Unsatisfactory 5. Very Unsatisfactory Scored when leaving recovery
Time frame: 10 minutes
Child Stress level by parent at daycare
Child Stress level by parent, 5- Point scale 1. Happy, plays 2. Slightly worried 3. Worried, stops playing 4. Fears, crying 5. Hysterical Scored at daycare-surgery (T0)
Time frame: 10 minutes
Child Stress level by parent at holding
Child Stress level by parent, 5- Point scale 1. Happy, plays 2. Slightly worried 3. Worried, stops playing 4. Fears, crying 5. Hysterical Scored at holding (T1)
Time frame: 10 minutes
Child Stress level by parent at OR
Child Stress level by parent, 5- Point scale 1. happy, plays 2. slightly worried 3. worried, stops playing 4. fear, crying 5. hysterical Scored at OR after induction (T2)
Time frame: 10 minutes
Child Stress level by parent at Recovery
Child Stress level by parent, 5- Point scale 1. Happy, plays 2. Slightly worried 3. Worried, stops playing 4. Fear, crying 5. Hysterical Scored at recovery (T3)
Time frame: 10 minutes
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
Time frame: 1 hour
Postoperative need for anti-nausea/vomiting medication
Postoperative need for anti-nausea/vomiting medication, indicated as yes or no, and description of product with given dose Noted on the recovery
Time frame: 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
Time frame: 2 hour
Plan to share: Yes — * Individual participant data will be available after deidentification * For researchers who provide a methodological proposal * Achieving aims in the proposal * Proposals needs to be directed to the principal investigators
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Universitair Ziekenhuis Brussel