Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-26 @ 9:51 PM
Study NCT ID:
NCT01891812
Status:
TERMINATED
Last Update Posted:
2024-07-16
First Post:
2013-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nitrous Oxide Analgesia Vaso-occlusive Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dst2141@cumc.columbia.edu', 'phone': '212 305 9825', 'title': 'Dr. Daniel Tsze, Professor of Pediatrics', 'organization': 'Columbia University Irving Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours', 'description': 'Patient-reported pain score immediately after administration of nitrous oxide. The full range of the pain score is 0 to 10; 0 = no pain, 10 = worst pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours', 'description': 'Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Peripheral Neuropathies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Complaints or physical findings suggestive of peripheral neuropathies (which may present as numbness, tingling, pain, or loss of feeling in fingers or toes; or weakness or difficulty moving the arms or legs) at the 8 week follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Macrocytic Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nitrous Oxide', 'description': 'Patients with Sickle cell disease and experiencing vaso-occlusive crises (VOC) with a pain score of greater than or equal to 7/10.\n\nPatients will receive the standard care of IV fluids, NSAIDs, and IV morphine or hydromorphone. The pain score will be reassessed 15 minutes after the initial pain scoring, and if the pain score is still greater than or equal to 7/10, nitrous oxide (N2O) will be administered at a concentration of 50% for 20 minutes.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0 - 7 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '8 - 17 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '18 - 65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-28', 'size': 175317, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-18T16:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Enrollment issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2013-06-29', 'resultsFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-21', 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Peripheral Neuropathies', 'timeFrame': '8 weeks', 'description': 'Complaints or physical findings suggestive of peripheral neuropathies (which may present as numbness, tingling, pain, or loss of feeling in fingers or toes; or weakness or difficulty moving the arms or legs) at the 8 week follow-up'}, {'measure': 'Number of Participants With Macrocytic Anemia', 'timeFrame': '8 weeks', 'description': 'The presence of macrocytic anemia at 8 weeks time in patients who had low vitamin B12 levels at the time of enrollment.'}], 'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Up to 4 hours', 'description': 'Patient-reported pain score immediately after administration of nitrous oxide. The full range of the pain score is 0 to 10; 0 = no pain, 10 = worst pain.'}], 'secondaryOutcomes': [{'measure': 'Duration of Analgesia', 'timeFrame': 'Up to 4 hours', 'description': 'Duration of analgesia (minutes) from time of administration of nitrous oxide until administration of additional analgesia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sickle cell disease', 'Vaso-occlusive crisis', 'Nitrous oxide', 'Emergency department'], 'conditions': ['Sickle Cell Disease', 'Vaso-occlusive Crisis']}, 'descriptionModule': {'briefSummary': 'Patients who have sickle cell VOC are usually treated with opioids, such as morphine. However, this current way of treating them has not improved the health, medical outcomes, or rates of hospitalizations. In addition, since VOC can happen very frequently over a long period of time, giving opioids over and over again can cause both short-term and long-term problems. Nitrous oxide (N2O) is a way of treating pain that may provide a better alternative to repeatedly giving opioids over long periods of time. N2O has been shown to provide up to 3 hours of pain relief in inpatient patients with VOC whose pain did not improve with morphine infusions, and is used extensively in France, where almost half of 85 pediatric emergency departments use nitrous oxide to treat children with VOC whose pain did not get better with standard treatment with morphine. However, pain relief which N2O provides in the acute setting has not been well described. Therefore, the purpose of our study is to describe how well N2O can relieve the pain in patients with SCD who present to the emergency department and are experiencing a VOC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with sickle cell disease\n* Ages 8 to 18, inclusive\n* Present to the pediatric emergency department with VOC and whose pain scores remain greater than or equal to 7/10 on the NRS after initial standard treatment (i.e. IV fluids, morphine and NSAIDs).\n\nExclusion Criteria:\n\n* life-threatening illness as determined by attending clinician\n* developmental delay\n* altered level of consciousness\n* any contraindications to receiving N2O\n* foster children and wards of the state'}, 'identificationModule': {'nctId': 'NCT01891812', 'briefTitle': 'Nitrous Oxide Analgesia Vaso-occlusive Crisis', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Nitrous Oxide for Analgesia in Sickle Cell Vaso-occlusive Crisis', 'orgStudyIdInfo': {'id': 'AAAK6900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous oxide 50%', 'description': 'Nitrous oxide 50% administered for 20 minutes.', 'interventionNames': ['Drug: Nitrous oxide 50%']}], 'interventions': [{'name': 'Nitrous oxide 50%', 'type': 'DRUG', 'armGroupLabels': ['Nitrous oxide 50%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "New York 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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics in Emergency Medicine', 'investigatorFullName': 'Daniel S Tsze, MD, MPH', 'investigatorAffiliation': 'Columbia University'}}}}