Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-12 @ 3:18 PM
Study NCT ID:
NCT02356705
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2015-02-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D008012', 'term': 'Lidocaine'}], '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'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'doccfi@hotmail.com', 'phone': '585-750-7510', 'title': 'Dr. David Ullman', 'organization': 'Bassett Healthcare'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During patient recovery - from time of entry into the recovery room until discharge (~3 hours)', 'eventGroups': [{'id': 'EG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'OG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'OG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'classes': [{'categories': [{'title': 'Agitated', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Alert', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Calm', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Drowsy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Asleep', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '25 minutes', 'description': 'Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement\n\n* 1\\. Agitated: Previous criteria and/or refuses mask. (worst score)\n* 2\\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion.\n* 3\\. Calm: Previous criteria and accepts mask.\n* 4\\. Drowsy: Previous criteria and accepts mask.\n* 5\\. Asleep: Previous criteria and accepts mask. (best score)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'OG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'OG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'classes': [{'categories': [{'title': 'Agitated', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Alert', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Calm', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Drowsy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Asleep', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 minutes', 'description': 'Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia\n\n* 1\\. Agitated: Patient clinging to parents and/or crying (worst score)\n* 2\\. Alert: Patient is aware but not clinging to parent, may whimper but not cry.\n* 3\\. Calm: Sitting or lying comfortably with spontaneous eye opening.\n* 4\\. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation.\n* 5\\. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'OG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'OG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '44'}, {'value': '39.5', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '50'}, {'value': '35.5', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '45'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'approximately 3 hours', 'description': 'The time (in minutes) from release from the operating room to discharge home', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'OG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'OG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approximately 3 hours', 'description': 'Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'OG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'OG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.6'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.6'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '1 minute', 'description': 'Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse.', 'unitOfMeasure': 'cm VAS', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'OG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'OG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.02'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0.01'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '5minutes', 'description': 'Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse.', 'unitOfMeasure': 'cm VAS', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'FG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'FG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline\n\nsaline placebo: intranasal saline given as placebo'}, {'id': 'BG001', 'title': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam\n\nMidazolam: midazolam 0.2 mg/kg given intranasally'}, {'id': 'BG002', 'title': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.\n\nMidazolam: midazolam 0.2 mg/kg given intranasally\n\nxylocaine: intransal xylocaine given in conjunction with intranasal midazolam'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '2.7', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2014-12-05', 'size': 317148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-08T16:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2015-02-02', 'resultsFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-08', 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Discharge', 'timeFrame': 'approximately 3 hours', 'description': 'The time (in minutes) from release from the operating room to discharge home'}, {'measure': 'Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home', 'timeFrame': 'approximately 3 hours', 'description': 'Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration.'}, {'measure': 'Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)', 'timeFrame': '1 minute', 'description': 'Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse.'}, {'measure': 'Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet)', 'timeFrame': '5minutes', 'description': 'Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse.'}], 'primaryOutcomes': [{'measure': 'Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement', 'timeFrame': '25 minutes', 'description': 'Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement\n\n* 1\\. Agitated: Previous criteria and/or refuses mask. (worst score)\n* 2\\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion.\n* 3\\. Calm: Previous criteria and accepts mask.\n* 4\\. Drowsy: Previous criteria and accepts mask.\n* 5\\. Asleep: Previous criteria and accepts mask. (best score)'}], 'secondaryOutcomes': [{'measure': 'Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room', 'timeFrame': '20 minutes', 'description': 'Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia\n\n* 1\\. Agitated: Patient clinging to parents and/or crying (worst score)\n* 2\\. Alert: Patient is aware but not clinging to parent, may whimper but not cry.\n* 3\\. Calm: Sitting or lying comfortably with spontaneous eye opening.\n* 4\\. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation.\n* 5\\. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': 'Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia\n2. American Society of Anesthesiologists (ASA) Class 1 or 2\n3. Parent willing and able to provide written informed consent\n4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)\n\nExclusion Criteria:\n\n1. ASA Class 3 or greater\n2. History of allergy to midazolam or xylocaine\n3. Presence of acute respiratory infection at time of surgery\n4. Parent unwilling or unable to provide informed consent\n5. Parent unwilling or unable to complete the OBD VAS'}, 'identificationModule': {'nctId': 'NCT02356705', 'briefTitle': 'Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2', 'organization': {'class': 'OTHER', 'fullName': 'Bassett Healthcare'}, 'officialTitle': 'Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2', 'orgStudyIdInfo': {'id': '1098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Placebo', 'description': 'Control patients will receive intranasal saline', 'interventionNames': ['Drug: saline placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal Midazolam Only', 'description': 'Patients will receive 0.2 mg/kg of intranasal midazolam', 'interventionNames': ['Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam Plus Xylocaine', 'description': 'Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.', 'interventionNames': ['Drug: Midazolam', 'Drug: xylocaine']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'midazolam 0.2 mg/kg given intranasally', 'armGroupLabels': ['Midazolam Plus Xylocaine', 'Nasal Midazolam Only']}, {'name': 'xylocaine', 'type': 'DRUG', 'description': 'intransal xylocaine given in conjunction with intranasal midazolam', 'armGroupLabels': ['Midazolam Plus Xylocaine']}, {'name': 'saline placebo', 'type': 'DRUG', 'description': 'intranasal saline given as placebo', 'armGroupLabels': ['Saline Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13326', 'city': 'Cooperstown', 'state': 'New York', 'country': 'United States', 'facility': 'Bassett Healthcare Network', 'geoPoint': {'lat': 42.70048, 'lon': -74.92426}}], 'overallOfficials': [{'name': 'david Ullman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bassett Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Victory, RN, CCRC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Nurse Supervisor', 'investigatorFullName': 'Jennifer Victory, RN, CCRC', 'investigatorAffiliation': 'Bassett Healthcare'}}}}