Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT04150757
Status:
TERMINATED
Last Update Posted:
2024-11-18
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}, {'id': 'D000377', 'term': 'Agnosia'}], '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': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients and treating providers will be aware of the medication administration.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). This is an observational study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Poor recruitment secondary to COVID', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score Using Wong Baker/FACES (age<11yr)', 'timeFrame': '30 minutes', 'description': 'Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.'}, {'measure': 'Change in Pain Score Using Numeric Rating Scale (age>11yr)', 'timeFrame': '30 minutes', 'description': 'Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. For patients 11 yrs and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.'}, {'measure': 'Change in Pain Score Using Wong Baker/FACES (age<11yr)', 'timeFrame': '15 minutes', 'description': 'Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.'}, {'measure': 'Change in Pain Score Using a Numeric Rating Scale (age>11yr)', 'timeFrame': '15 minutes', 'description': 'Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. For patients older than 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.'}, {'measure': 'Change in Pain Score Using Wong Baker/FACES (age<11yr)', 'timeFrame': '15 minutes', 'description': 'Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.'}, {'measure': 'Change in Pain Score Using a Numeric Rating Scale (age>11yr)', 'timeFrame': '15 minutes', 'description': 'Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. For patients 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.'}], 'secondaryOutcomes': [{'measure': 'Additional Opiate Medication', 'timeFrame': 'Duration of ED visit, an average of 5 hrs', 'description': 'Number of opiate analgesic doses and a comparison of opiate equivalents/kilogram versus mean dose for prior visits (if the patient has been seen for VOE prior)'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'At patient disposition, an average of 5 hrs', 'description': 'Patient/Parent satisfaction based on questionnaire. Patients will answer based on a 4 point scale (not happy at all/a little happy/happy\\&satisfied/very happy)'}, {'measure': 'Rate of Admission', 'timeFrame': 'Duration of ED visit, an average of 5 hrs', 'description': 'Percentage of patients within each group who are admitted (vs discharged)'}, {'measure': 'Rate of Return Visit', 'timeFrame': '1 week', 'description': 'Percentage of patients within each group who have a return visit documented in the electronic medical record within 1 week of the ER visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease', 'Vaso-Occlusive Pain Episode in Sickle Cell Disease', 'Vaso-occlusive Crisis', 'Ketamine', 'Intranasal Ketamine', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.', 'detailedDescription': 'This will be a prospective observational cohort involving patients 3 to 25 years of age who present to the Pediatric Emergency Department (PED) at Jacobi Medical Center with vaso-occlusive episode (VOE) in moderate-severe pain (FACES or numeric rating scale ≥5) as determined at triage. Currently, the standard of treatment for VOE at our institution is intravenous (IV) line placement and IV opioid analgesia. The patient will receive intranasal (IN) Ketamine as the first parental analgesic, so as to provide more immediate pain relief while they wait for IV placement and IV analgesia, for opioid pain control, which is currently the standard of care at our institution. The primary objective of this study is to describe the analgesic effect of IN ketamine in treating moderate-to-severe pain due to VOE in the pediatric ED as measured by a pain scale rating at various time intervals following administration. Secondary objectives are to describe the effect of IN ketamine on the need for additional doses of opioid medications, patient satisfaction and disposition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of Hemoglobin SS or SC disease\n* Age 3 years old to 25 years old presenting to the PED with vaso-occlusive with moderate-severe pain determined at triage as pain score (FACES or numeric rating scale) ≥ 5\n* Parent or patient willing to provide consent/assent\n* English speaking\n\nExclusion Criteria:\n\n* Patient with concern for more severe complications including acute chest, splenic sequestration, sepsis, stroke, non-VOC pain, asthma exacerbation\n* Allergy to ketamine\n* GCS\\<15\n* Obstructive nasal anatomy as per parent history\n* History of a psychiatric disorder\n* Pregnant patients will be excluded. Female patients \\> 12 years old are routinely tested for pregnancy in our PED. Patients found to be pregnant will not be enrolled in study.'}, 'identificationModule': {'nctId': 'NCT04150757', 'briefTitle': 'Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED', 'organization': {'class': 'OTHER', 'fullName': 'New York City Health and Hospitals Corporation'}, 'officialTitle': 'The Use of Intranasal (IN) Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the Pediatric Emergency Department', 'orgStudyIdInfo': {'id': '2019-10379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Analgesia', 'description': 'Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intranasal Ketamine + Standard Analgesia', 'description': 'Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg).', 'interventionNames': ['Drug: Intranasal ketamine']}], 'interventions': [{'name': 'Intranasal ketamine', 'type': 'DRUG', 'description': 'Patients with vaso-occlusive episode and sickle cell disease in moderate to severe pain determined at triage will receive intranasal ketamine while awaiting IV placement.', 'armGroupLabels': ['Intranasal Ketamine + Standard Analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'JACOBI', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abigail Nixon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator, MD', 'investigatorFullName': 'Abigail Nixon', 'investigatorAffiliation': 'New York City Health and Hospitals Corporation'}}}}