Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 11:24 AM
Study NCT ID:
NCT04273035
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'digital block randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A: midazolam premedicated, standard of care Group B: IPAD, no midazolam premedication'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative need for pain medication', 'timeFrame': '1 hour', 'description': 'Postoperative need for pain medication, indicated as yes or no, and description of medication with given dose Noted on the recovery'}, {'measure': 'Postoperative need for anti-nausea/vomiting medication', 'timeFrame': '1 hour', 'description': 'Postoperative need for anti-nausea/vomiting medication, indicated as yes or no, and description of product with given dose Noted on the recovery'}, {'measure': 'Time arrival recovery to time leaving recovery', 'timeFrame': '2 hour', 'description': 'Time arrival recovery to time leaving recovery, time notation on arrival and leaving Noted on the recovery'}], 'primaryOutcomes': [{'measure': 'Anxiety level at induction', 'timeFrame': 'Directly prior to induction of anesthesia, 20 minutes', 'description': '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)'}, {'measure': 'Anesthesiologist Satisfaction Induction', 'timeFrame': 'During induction of anesthesia 10 minutes', 'description': 'Satisfactory Score for Induction/Anesthesia: 5 point scale: Very satisfactory, Satisfactory, Neutral, Unsatisfactory and Very satisfactory Scored in the OR directly post induction'}], 'secondaryOutcomes': [{'measure': 'Anxiety level at Daycare', 'timeFrame': 'Leaving daycare, 10 minutes', 'description': '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': 'Anxiety level at holding', 'timeFrame': 'On holding, 20 minutes', 'description': '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'}, {'measure': 'Anxiety level at recovery', 'timeFrame': '15 minutes after awake, 30 minutes', 'description': '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'}, {'measure': 'Anxiety level Change Daycare vs OR', 'timeFrame': 'change during daycare (T0) and induction(T2) in the OR, average 1 hour', 'description': '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'}, {'measure': 'Sedation level at Daycare', 'timeFrame': '10 minutes', 'description': 'Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at Daycare (T0) when leaving to holding'}, {'measure': 'Sedation level at holding', 'timeFrame': '20 minutes', 'description': 'Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored (T1) 10 minutes after arrival holding'}, {'measure': 'Sedation level at induction', 'timeFrame': '10 minutes', 'description': 'Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored at moment of mask induction (T2)'}, {'measure': 'Sedation level at recovery', 'timeFrame': '30 minutes', 'description': 'Richmond Agitation-Sedation Scale, RASS-score between -5 till + 4 Scored 15 minutes after arrival recovery (T3)'}, {'measure': 'Laryngospasm at induction', 'timeFrame': '10 minutes', 'description': 'Laryngospasm by Four-point scale:\n\n1. No Laryngospasm\n2. Mild laryngospasm (relieved by jaw thrust and 100% oxygen),\n3. Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation)\n4. Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post-induction'}, {'measure': 'Laryngospasm post extubation/post laryngeal mask', 'timeFrame': '10 minutes', 'description': 'Laryngospasm by Four-point scale:\n\n1. No Laryngospasm\n2. Mild laryngospasm (relieved by jaw thrust and 100% oxygen),\n3. Moderate laryngospasm (relieved by 100% oxygen and positive pressure ventilation)\n4. Severe laryngospasm (relieved by succinylcholine and intubation) Scored in the OR post detubation/post laryngeal mask'}, {'measure': 'Bronchospasm postinduction', 'timeFrame': '10 minutes', 'description': 'Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR postinduction'}, {'measure': 'Bronchospasm post detubation/laryngeal mask', 'timeFrame': '10 minutes', 'description': 'Bronchospasm/wheezing 1. Yes 2. No • In absence of scale Scored in the OR post detonation/laryngeal mask'}, {'measure': 'Postoperative Pain', 'timeFrame': '40 minutes', 'description': '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'}, {'measure': 'Parental Satisfaction on the anxiety-management at daycare', 'timeFrame': '10 minutes', 'description': '1. Very satisfied\n2. Satisfied\n3. Neutral\n4. Unsatisfactory\n5. Very Unsatisfactory Scored at daycare-surgery (T0)'}, {'measure': 'Parental Satisfaction on the anxiety-management at holding', 'timeFrame': '10 minutes', 'description': '1. Very satisfied\n2. Satisfied\n3. Neutral\n4. Unsatisfactory\n5. Very Unsatisfactory Scored at holding (T1)'}, {'measure': 'Parental Satisfaction on the anxiety-management at OR', 'timeFrame': '10 minutes', 'description': '1. Very satisfied\n2. Satisfied\n3. Neutral\n4. Unsatisfactory\n5. Very Unsatisfactory Scored after induction and parent has left the OR (T2)'}, {'measure': 'Parental Satisfaction on the anxiety-management at recovery', 'timeFrame': '10 minutes', 'description': '1. Very satisfied\n2. Satisfied\n3. Neutral\n4. Unsatisfactory\n5. Very Unsatisfactory Scored at the recovery (T3)'}, {'measure': 'Parental Stress level at day care', 'timeFrame': '10 minutes', 'description': "Parental Stress level in 5 - point scale- ´I feel':\n\n1. Extremely Stressed\n2. Very stressed\n3. moderate stressed\n4. Low stressed\n5. Very low stressed scored at day care (T0)"}, {'measure': 'Parental Stress level at holding', 'timeFrame': '10 minutes', 'description': "Parental Stress level in 5 - point scale- ´I feel':\n\n1. Extremely Stressed\n2. Very stressed\n3. moderate stressed\n4. Low stressed\n5. Very low stressed Scored at holding (T1)"}, {'measure': 'Parental Stress level at OR', 'timeFrame': '10 minutes', 'description': "Parental Stress level in 5 - point scale- ´I feel':\n\n1. Extremely Stressed\n2. Very stressed\n3. moderate stressed\n4. Low stressed\n5. Very low stressed Scored at OR (T2)"}, {'measure': 'Parental Stress level at recovery', 'timeFrame': '10 minutes', 'description': "Parental Stress level in 5 - point scale- ´I feel':\n\n1. Extremely Stressed\n2. Very stressed\n3. moderate stressed\n4. Low stressed\n5. Very low stressed Scored at recovery (T3)"}, {'measure': 'Overall Parental Satisfaction', 'timeFrame': '10 minutes', 'description': '5- Point scale\n\n1. Very satisfied\n2. Satisfied\n3. Neutral\n4. Unsatisfactory\n5. Very Unsatisfactory Scored when leaving recovery'}, {'measure': 'Child Stress level by parent at daycare', 'timeFrame': '10 minutes', 'description': 'Child Stress level by parent, 5- Point scale\n\n1. Happy, plays\n2. Slightly worried\n3. Worried, stops playing\n4. Fears, crying\n5. Hysterical Scored at daycare-surgery (T0)'}, {'measure': 'Child Stress level by parent at holding', 'timeFrame': '10 minutes', 'description': 'Child Stress level by parent, 5- Point scale\n\n1. Happy, plays\n2. Slightly worried\n3. Worried, stops playing\n4. Fears, crying\n5. Hysterical Scored at holding (T1)'}, {'measure': 'Child Stress level by parent at OR', 'timeFrame': '10 minutes', 'description': 'Child Stress level by parent, 5- Point scale\n\n1. happy, plays\n2. slightly worried\n3. worried, stops playing\n4. fear, crying\n5. hysterical Scored at OR after induction (T2)'}, {'measure': 'Child Stress level by parent at Recovery', 'timeFrame': '10 minutes', 'description': 'Child Stress level by parent, 5- Point scale\n\n1. Happy, plays\n2. Slightly worried\n3. Worried, stops playing\n4. Fear, crying\n5. Hysterical Scored at recovery (T3)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preanesthetic medication', 'Handheld computer', 'Midazolam', 'Multimedia', 'Anxiety', 'Mask induction', 'Day Care Surgery'], 'conditions': ['Perioperative Anxiety', 'Preanesthetic Medication', 'Inhalation Anesthesia', 'Ambulatory Surgery', 'Tonsillectomy', 'Circumcision', 'Dental Care']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPremedication 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.\n\nNon-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.\n\nObjective:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age ≥ 1 year and \\<8 years old\n* ASA class 1 or 2 (American Society of Anesthesiologists Physical Status Classification System)\n* Elective circumcision, tonsillectomy or adenoidectomy, dental care procedure in day-care\n* Written informed consent by the legal parents or caretaker\n\nExclusion criteria\n\n* Parents of the patient wish not to participate with the study\n* Parents are not able to give informed consent (language barrier, legally incapable)\n* A contraindication for the use of premedication with midazolam\n* A known allergy to midazolam\n* A contraindication for premedication in general\n* A contraindication for the use of a gas-induction/gas-anesthesia\n* A contraindication for the use of sevoflurane\n* A known mental retardation of the child\n* Preoperative behavioral disturbances and psychiatric disorders\n* Any use of psychoactive medication\n* A known photosensitive epilepsy\n* A previous operation within 3 months of the time of scheduled operation\n* Any other contraindication for the use of the study medication\n* Previous history of multiple surgery (\\>3)'}, 'identificationModule': {'nctId': 'NCT04273035', 'briefTitle': 'Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'The Effect of Handheld-multimedia Versus Oral Midazolam Preanesthetic on the Level of Perioperative Anxiety in Pediatric Day-care Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019/318'}, 'secondaryIdInfos': [{'id': '2019-004671-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam Group', 'description': '* Midazolam(Buccolam 5mg/ml)\n* 0.5mg/kg oral, max 12mg\n* one time\n* given 30 min prior to going to holding', 'interventionNames': ['Drug: Midazolam oral solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IPAD group', 'description': '* No premedication\n* IPAD when arriving at the holding\n* any games, movies, clips, puzzles', 'interventionNames': ['Device: IPAD']}], 'interventions': [{'name': 'Midazolam oral solution', 'type': 'DRUG', 'otherNames': ['Buccolam'], 'description': 'Oral Buccolam', 'armGroupLabels': ['Midazolam Group']}, {'name': 'IPAD', 'type': 'DEVICE', 'otherNames': ['Handheld multimedia, tablet'], 'description': 'Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia', 'armGroupLabels': ['IPAD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Alex Van Hoorn, MD', 'role': 'CONTACT', 'email': 'Alex.VanHoorn@uzbrussel.be', 'phone': '+324749232'}, {'name': 'Pangiotis Flamée, MD', 'role': 'CONTACT', 'email': 'Panagiotis.Flamee@uzbrussel.be', 'phone': '+324773143'}, {'name': 'Alex Van Hoorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pangiotis Flamée, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Ziekenhuis Brussel (UZ Brussel)', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'centralContacts': [{'name': 'Alex Van Hoorn, MD', 'role': 'CONTACT', 'email': 'Alex.VanHoorn@uzbrussel.be', 'phone': '+32468187852'}, {'name': 'Panagiotis Flamée, MD', 'role': 'CONTACT', 'email': 'Panagiotis.Flamee@uzbrussel.be', 'phone': '+3224773143'}], 'overallOfficials': [{'name': 'Alex Van Hoorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident of department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Available 3 months after study publication for 10 years', 'ipdSharing': 'YES', 'description': '* Individual participant data will be available after deidentification\n* For researchers who provide a methodological proposal\n* Achieving aims in the proposal\n* Proposals needs to be directed to the principal investigators', 'accessCriteria': 'Written request and providing a methodological proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}