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Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

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ClinicalTrials.gov Identifier: NCT04273035
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Perioperative Anxiety Preanesthetic Medication Inhalation Anesthesia Ambulatory Surgery Tonsillectomy Circumcision Dental Care Drug: Midazolam oral solution Device: IPAD Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication
Masking: None (Open Label)
Masking Description: digital block randomization
Primary Purpose: Treatment
Official Title: The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Midazolam Group
  • Midazolam(Buccolam 5mg/ml)
  • 0.5mg/kg oral, max 12mg
  • one time
  • given 30 min prior to going to holding
Drug: Midazolam oral solution
Oral Buccolam
Other Name: Buccolam

Active Comparator: IPAD group
  • No premedication
  • IPAD when arriving at the holding
  • any games, movies, clips, puzzles
Device: IPAD
Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia
Other Name: Handheld multimedia, tablet




Primary Outcome Measures :
  1. Anxiety level at induction [ Time Frame: Directly prior to induction of anesthesia, 20 minutes ]
    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)

  2. Anesthesiologist Satisfaction Induction [ Time Frame: During induction of anesthesia 10 minutes ]
    Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction


Secondary Outcome Measures :
  1. Anxiety level at Daycare [ Time Frame: Leaving daycare, 10 minutes ]
    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

  2. Anxiety level at holding [ Time Frame: On holding, 20 minutes ]
    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

  3. Anxiety level at recovery [ Time Frame: 15 minutes after awake, 30 minutes ]
    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

  4. Anxiety level Change Daycare vs OR [ Time Frame: change during daycare (T0) and induction(T2) in the OR, average 1 hour ]
    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

  5. Sedation level at Daycare [ Time Frame: 10 minutes ]
    Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding

  6. Sedation level at holding [ Time Frame: 20 minutes ]
    Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding

  7. Sedation level at induction [ Time Frame: 10 minutes ]
    Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)

  8. Sedation level at recovery [ Time Frame: 30 minutes ]
    Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)

  9. Laryngospasm at induction [ Time Frame: 10 minutes ]

    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

  10. Laryngospasm post extubation/post laryngeal mask [ Time Frame: 10 minutes ]

    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

  11. Bronchospasm postinduction [ Time Frame: 10 minutes ]
    Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction

  12. Bronchospasm post detubation/laryngeal mask [ Time Frame: 10 minutes ]
    Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR post detonation/laryngeal mask

  13. Postoperative Pain [ Time Frame: 40 minutes ]
    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

  14. Parental Satisfaction on the anxiety-management at daycare [ Time Frame: 10 minutes ]
    1. Very satisfied
    2. Satisfied
    3. Neutral
    4. Unsatisfactory
    5. Very Unsatisfactory Scored at daycare-surgery (T0)

  15. Parental Satisfaction on the anxiety-management at holding [ Time Frame: 10 minutes ]
    1. Very satisfied
    2. Satisfied
    3. Neutral
    4. Unsatisfactory
    5. Very Unsatisfactory Scored at holding (T1)

  16. Parental Satisfaction on the anxiety-management at OR [ Time Frame: 10 minutes ]
    1. Very satisfied
    2. Satisfied
    3. Neutral
    4. Unsatisfactory
    5. Very Unsatisfactory Scored after induction and parent has left the OR (T2)

  17. Parental Satisfaction on the anxiety-management at recovery [ Time Frame: 10 minutes ]
    1. Very satisfied
    2. Satisfied
    3. Neutral
    4. Unsatisfactory
    5. Very Unsatisfactory Scored at the recovery (T3)

  18. Parental Stress level at day care [ Time Frame: 10 minutes ]

    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)

  19. Parental Stress level at holding [ Time Frame: 10 minutes ]

    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)

  20. Parental Stress level at OR [ Time Frame: 10 minutes ]

    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)

  21. Parental Stress level at recovery [ Time Frame: 10 minutes ]

    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)

  22. Overall Parental Satisfaction [ Time Frame: 10 minutes ]

    5- Point scale

    1. Very satisfied
    2. Satisfied
    3. Neutral
    4. Unsatisfactory
    5. Very Unsatisfactory Scored when leaving recovery

  23. Child Stress level by parent at daycare [ Time Frame: 10 minutes ]

    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)

  24. Child Stress level by parent at holding [ Time Frame: 10 minutes ]

    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)

  25. Child Stress level by parent at OR [ Time Frame: 10 minutes ]

    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)

  26. Child Stress level by parent at Recovery [ Time Frame: 10 minutes ]

    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)


Other Outcome Measures:
  1. Postoperative need for pain medication [ Time Frame: 1 hour ]
    Postoperative need for pain medication, indicated as yes or no, and description of medication with given dose Noted on the recovery

  2. Postoperative need for anti-nausea/vomiting medication [ Time Frame: 1 hour ]
    Postoperative need for anti-nausea/vomiting medication, indicated as yes or no, and description of product with given dose Noted on the recovery

  3. Time arrival recovery to time leaving recovery [ Time Frame: 2 hour ]
    Time arrival recovery to time leaving recovery, time notation on arrival and leaving Noted on the recovery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273035


Contacts
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Contact: Alex Van Hoorn, MD +32468187852 Alex.VanHoorn@uzbrussel.be
Contact: Panagiotis Flamée, MD +3224773143 Panagiotis.Flamee@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel (UZ Brussel) Recruiting
Jette, Belgium, 1090
Contact: Alex Van Hoorn, MD    +324749232    Alex.VanHoorn@uzbrussel.be   
Contact: Pangiotis Flamée, MD    +324773143    Panagiotis.Flamee@uzbrussel.be   
Principal Investigator: Alex Van Hoorn, MD         
Principal Investigator: Pangiotis Flamée, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Alex Van Hoorn, MD Resident of department of Anesthesiology

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04273035    
Other Study ID Numbers: 2019/318
2019-004671-39 ( EudraCT Number )
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  • 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Available 3 months after study publication for 10 years
Access Criteria: Written request and providing a methodological proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universitair Ziekenhuis Brussel:
Preanesthetic medication
Handheld computer
Midazolam
Multimedia
Anxiety
Mask induction
Day Care Surgery
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action