Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT04586504
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dst2141@cumc.columbia.edu', 'phone': '212-317-0997', 'title': 'Daniel Tsze MD MPH', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)', 'eventGroups': [{'id': 'EG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paradoxical reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Children Who Achieved PSSS Score 2, 3, or 4 for 95% or Greater of the Scored Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study drug administration until procedure finished (approximately 60 minutes)', 'description': 'The Pediatric Sedation State Scale (PSSS) is scored from 0 to 5, representing a continuum of sedation that spans from over-sedation associated with changes in vital signs (0) to inadequate sedation (5).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study drug administration until patient discharge (approximately 120 minutes)', 'description': 'Time (in minutes) from procedure completion until a Simplified Aldrete Score (SAS) of at least 6 is achieved. The score ranges from 0 (lowest) to 8 (highest). If a patient already fulfills criteria for recovery at procedure start, then time to recovery is 0.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From study drug administration until patient discharge (approximately 120 minutes)', 'description': 'Adverse events will be defined using the Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Network Consensus-Based Recommendations. These adverse events include oxygen desaturation; apnea (central, obstructive, laryngospasm); clinically apparent pulmonary aspiration; retching/vomiting; bradycardia; hypotension; excitatory movements; paradoxical response to sedation; unpleasant recovery reactions; and permanent complications (including death).', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Minimal Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '6.6'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '5'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '4.4'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From study drug administration until procedure finished (approximately 60 minutes)', 'description': 'Time (in minutes) from administration of intranasal midazolam until a University of Michigan Sedation State (UMSS) score of 1 is achieved. The UMSS represents a spectrum of depth of sedation ranging from unarousable (4) to awake and alert (0). Note: This outcome was initially listed as a primary outcome, but was changed to a secondary outcome in the IRB-approved protocol and prior to enrollment of the first patient.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'UMSS Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'OG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}], 'classes': [{'title': 'UMSS = 0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'UMSS = 1', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'UMSS = 2, 3 or 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study drug administration until procedure finished (approximately 60 minutes)', 'description': 'Depth of sedation will be measured using the University of Michigan Sedation Scale (UMSS). This sedation scale ranges from zero to four with higher numbers indicating deeper sedation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'FG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'FG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'FG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'BG001', 'title': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'BG002', 'title': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'BG003', 'title': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.\n\nIntranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '3.8'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2.5', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '2.5', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG004', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-06', 'size': 371715, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-28T09:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sequential selection procedure'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2020-10-12', 'resultsFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Children Who Achieved PSSS Score 2, 3, or 4 for 95% or Greater of the Scored Procedure', 'timeFrame': 'From study drug administration until procedure finished (approximately 60 minutes)', 'description': 'The Pediatric Sedation State Scale (PSSS) is scored from 0 to 5, representing a continuum of sedation that spans from over-sedation associated with changes in vital signs (0) to inadequate sedation (5).'}], 'secondaryOutcomes': [{'measure': 'Time to Recovery', 'timeFrame': 'From study drug administration until patient discharge (approximately 120 minutes)', 'description': 'Time (in minutes) from procedure completion until a Simplified Aldrete Score (SAS) of at least 6 is achieved. The score ranges from 0 (lowest) to 8 (highest). If a patient already fulfills criteria for recovery at procedure start, then time to recovery is 0.'}, {'measure': 'Number of Adverse Events', 'timeFrame': 'From study drug administration until patient discharge (approximately 120 minutes)', 'description': 'Adverse events will be defined using the Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Network Consensus-Based Recommendations. These adverse events include oxygen desaturation; apnea (central, obstructive, laryngospasm); clinically apparent pulmonary aspiration; retching/vomiting; bradycardia; hypotension; excitatory movements; paradoxical response to sedation; unpleasant recovery reactions; and permanent complications (including death).'}, {'measure': 'Time to Onset of Minimal Sedation', 'timeFrame': 'From study drug administration until procedure finished (approximately 60 minutes)', 'description': 'Time (in minutes) from administration of intranasal midazolam until a University of Michigan Sedation State (UMSS) score of 1 is achieved. The UMSS represents a spectrum of depth of sedation ranging from unarousable (4) to awake and alert (0). Note: This outcome was initially listed as a primary outcome, but was changed to a secondary outcome in the IRB-approved protocol and prior to enrollment of the first patient.'}, {'measure': 'UMSS Scale Score', 'timeFrame': 'From study drug administration until procedure finished (approximately 60 minutes)', 'description': 'Depth of sedation will be measured using the University of Michigan Sedation Scale (UMSS). This sedation scale ranges from zero to four with higher numbers indicating deeper sedation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intranasal', 'Midazolam', 'Pediatric', 'Laceration repair', 'Sedation', 'Anxiolysis', 'Adaptive trial design', 'Dose finding'], 'conditions': ['Procedural Anxiety']}, 'referencesModule': {'references': [{'pmid': '27823876', 'type': 'BACKGROUND', 'citation': 'Tsze DS, Ieni M, Fenster DB, Babineau J, Kriger J, Levin B, Dayan PS. Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial. Ann Emerg Med. 2017 May;69(5):600-609. doi: 10.1016/j.annemergmed.2016.08.450. Epub 2016 Nov 4.'}, {'pmid': '28557732', 'type': 'BACKGROUND', 'citation': 'Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897.'}, {'pmid': '28992870', 'type': 'BACKGROUND', 'citation': 'Mellion SA, Bourne D, Brou L, Brent A, Adelgais K, Galinkin J, Wathen J. Evaluating Clinical Effectiveness and Pharmacokinetic Profile of Atomized Intranasal Midazolam in Children Undergoing Laceration Repair. J Emerg Med. 2017 Sep;53(3):397-404. doi: 10.1016/j.jemermed.2017.05.029.'}, {'type': 'BACKGROUND', 'citation': 'Leu C-S, Levin B. On the probability of correct selection in the Levin-Robbins sequential elimination procedure. Stat Sin 1999;9(3):879-91.'}, {'pmid': '11878656', 'type': 'BACKGROUND', 'citation': 'Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N. Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS). Br J Anaesth. 2002 Feb;88(2):241-5. doi: 10.1093/bja/88.2.241.'}, {'pmid': '19026467', 'type': 'BACKGROUND', 'citation': 'Bhatt M, Kennedy RM, Osmond MH, Krauss B, McAllister JD, Ansermino JM, Evered LM, Roback MG; Consensus Panel on Sedation Research of Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN). Consensus-based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2009 Apr;53(4):426-435.e4. doi: 10.1016/j.annemergmed.2008.09.030. Epub 2008 Nov 20.'}, {'pmid': '3430286', 'type': 'BACKGROUND', 'citation': "Elliott CH, Jay SM, Woody P. An observation scale for measuring children's distress during medical procedures. J Pediatr Psychol. 1987 Dec;12(4):543-51. doi: 10.1093/jpepsy/12.4.543. No abstract available."}, {'pmid': '40720114', 'type': 'RESULT', 'citation': 'Tsze DS, Woodward HA, McLaren SH, Leu CS, Venn AMR, Hu NY, Flores-Sanchez PL, Stefan BR, Shen ST, Ekladios MJ, Cravero JP, Dayan PS. Optimal Dose of Intranasal Midazolam for Procedural Sedation in Children: A Randomized Clinical Trial. JAMA Pediatr. 2025 Sep 1;179(9):979-986. doi: 10.1001/jamapediatrics.2025.2181.'}]}, 'descriptionModule': {'briefSummary': 'Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:\n\nSpecific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.\n\nSpecific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.', 'detailedDescription': 'Intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. However, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. Doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. There is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. There is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. To fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 6 months to 7 years old (i.e. before their 8th birthday)\n* Simple laceration\n* Attending physician has decided intranasal midazolam indicated to facilitate repair\n\nExclusion Criteria:\n\n* Repair using tissue adhesive (e.g. Dermabond) or staples\n* Known or confirmed developmental delay\n* Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)\n* Autism spectrum disorder\n* Illness associated with chronic pain\n* Known allergy to midazolam or any other benzodiazepine\n* Eyelid laceration\n* Tongue or intraoral lacerations\n* Nasal obstruction that cannot be easily cleared\n* Does not speak English or Spanish\n* Foster children, wards of the state'}, 'identificationModule': {'nctId': 'NCT04586504', 'briefTitle': 'Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children', 'orgStudyIdInfo': {'id': 'AAAS7996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.2 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.', 'interventionNames': ['Drug: Intranasal midazolam']}, {'type': 'EXPERIMENTAL', 'label': '0.3 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.', 'interventionNames': ['Drug: Intranasal midazolam']}, {'type': 'EXPERIMENTAL', 'label': '0.4 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.', 'interventionNames': ['Drug: Intranasal midazolam']}, {'type': 'EXPERIMENTAL', 'label': '0.5 mg/kg', 'description': 'Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.', 'interventionNames': ['Drug: Intranasal midazolam']}], 'interventions': [{'name': 'Intranasal midazolam', 'type': 'DRUG', 'otherNames': ['IN midazolam'], 'description': '5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.', 'armGroupLabels': ['0.2 mg/kg', '0.3 mg/kg', '0.4 mg/kg', '0.5 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "NewYork Presbyterian Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Daniel S. Tsze, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emergency Medicine Foundation', 'class': 'OTHER'}, {'name': 'Mailman School of Public Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics in Emergency Medicine', 'investigatorFullName': 'Daniel S Tsze, MD, MPH', 'investigatorAffiliation': 'Columbia University'}}}}