Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT05368961
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2022-04-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019857', 'term': 'Osteogenesis, Distraction'}], 'ancestors': [{'id': 'D001852', 'term': 'Bone Lengthening'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'levaym@ccf.org', 'phone': '216-445-4749', 'title': 'Michelle Levay, Nurse Research Manager', 'phoneExt': '54749', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time in study = time they received the intervention (control or experimental) until discharged from post anesthesia care unit. Each participant was in the study from 2-6 hours. Operating room times varied by surgical procedure.', 'description': 'Not applicable, no adverse events reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'OG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Null hypothesis; there is no difference in anxiety scores between usual care and distraction'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-induction of mask anesthesia in the operating room', 'description': 'Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety.\n\nA categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedation/Agitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'OG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'classes': [{'title': 'Sedated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calm', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Agitated', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-induction of mask anesthesia in the operating room', 'description': 'Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)\n\nThe RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Emergence Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'OG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After surgery when patient woke up in the post anesthesia care unit (recovery room)', 'description': 'Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool.\n\nThe scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedation/Agitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'OG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'classes': [{'title': 'Sedated', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Calm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Agitated', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After surgery at the time of admission to post anesthesia care unit (recovery room)', 'description': 'Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)\n\nThe RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay (Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'OG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '78.0', 'upperLimit': '101.0'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '59.5', 'upperLimit': '98.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post operative until discharged from post anesthesia care unit (recovery room)', 'description': 'Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients Experiencing Postoperative Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'OG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After surgery in the post anesthesia care unit from admission to discharge', 'description': 'The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'FG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Children ages 3-5 years were recruited from the pre-operative area at a single surgery site between April 2017 to March 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual care (midazolam) is administered pre-operatively\n\nUsual care: Anxiolytic ordered by anesthesiologist is usual care'}, {'id': 'BG001', 'title': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively\n\nDistraction: Distraction (interactive tablet)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '3 years old', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '4 years old', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': '5 years old', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of surgery', 'classes': [{'title': 'Ear Nose Throat', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Ophthalmology', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Urology', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'General Surgery', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data was not reported on participants lost to attrition'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-26', 'size': 421179, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-26T10:45', 'hasProtocol': True}, {'date': '2018-03-26', 'size': 216361, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-26T10:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not a blinded study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: usual care Group 2: distraction'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2022-04-28', 'resultsFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-28', 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"', 'timeFrame': 'Pre-induction of mask anesthesia in the operating room', 'description': 'Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); scores range 23-100 with higher scores indicating greater levels of anxiety.\n\nA categorical variable was created using a cut-off score of 30 or more to indicate "anxiety" and scores of less than 30 indicated "no anxiety".'}], 'secondaryOutcomes': [{'measure': 'Sedation/Agitation', 'timeFrame': 'Pre-induction of mask anesthesia in the operating room', 'description': 'Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)\n\nThe RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".'}, {'measure': 'Number of Participants Experiencing Emergence Delirium', 'timeFrame': 'After surgery when patient woke up in the post anesthesia care unit (recovery room)', 'description': 'Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool.\n\nThe scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of "emergence delirium."'}, {'measure': 'Sedation/Agitation', 'timeFrame': 'After surgery at the time of admission to post anesthesia care unit (recovery room)', 'description': 'Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS)\n\nThe RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated "agitation", scores of +1 to -1 were "calm", and scores of -2 or lower indicated "sedation".'}, {'measure': 'Length of Stay (Minutes)', 'timeFrame': 'Post operative until discharged from post anesthesia care unit (recovery room)', 'description': 'Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.'}, {'measure': 'The Number of Patients Experiencing Postoperative Vomiting', 'timeFrame': 'After surgery in the post anesthesia care unit from admission to discharge', 'description': 'The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '25040433', 'type': 'BACKGROUND', 'citation': 'Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.'}, {'pmid': '15114210', 'type': 'BACKGROUND', 'citation': 'Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.'}, {'pmid': '15562048', 'type': 'BACKGROUND', 'citation': 'Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.'}]}, 'descriptionModule': {'briefSummary': 'Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old', 'detailedDescription': 'Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3-5 year old children\n* Scheduled for elective surgery\n* American Society of Anesthesiologists physical status classification system: I - II\n\nExclusion Criteria:\n\n* Children younger than 3 or older than 6\n* Allergy to midazolam\n* Cognitive or developmental delays\n* American Society of Anesthesiologists physical status classification system: III - VI\n* Anesthesia provider determines child is not eligible\n* Children that are transferred to ICU after surgery'}, 'identificationModule': {'nctId': 'NCT05368961', 'briefTitle': 'Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Comparison of Midazolam (Versed) and Distraction on Anxiety, Emergence Delirium, Sedation/Agitation, and Vomiting in Pre-operative Patients Ages 3 to 5.', 'orgStudyIdInfo': {'id': '16-511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care (midazolam) is administered pre-operatively', 'interventionNames': ['Other: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Distraction', 'description': 'Distraction (interactive tablet) is given to children pre-operatively', 'interventionNames': ['Behavioral: Distraction']}], 'interventions': [{'name': 'Distraction', 'type': 'BEHAVIORAL', 'description': 'Distraction (interactive tablet)', 'armGroupLabels': ['Distraction']}, {'name': 'Usual care', 'type': 'OTHER', 'otherNames': ['Anxiolytic per anesthesia'], 'description': 'Anxiolytic ordered by anesthesiologist is usual care', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Nancy M Albert, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michelle Levay', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}