Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-04-19 @ 10:15 PM
Study NCT ID:
NCT01851720
Status:
TERMINATED
Last Update Posted:
2017-06-22
First Post:
2013-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acoon2@jhmi.edu', 'phone': '410-955-2438', 'title': 'Alex Coon', 'organization': 'Johns Hopkins School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group / Standard of Care', 'description': '* IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain\n* (Bolus dose can be titrated up in 25 mcg increments if necessary)\n* Maximum dose of 100 mcg/hr\n\nStandard IV fentanyl bolus', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose IV Fentanyl PCA', 'description': '* Initially: 10 mcg demand dose every 12 minutes\n* No initial bolus and no continuous infusion\n* Demand dose increased 10 mcg every 12 minutes if necessary\n* Maximum dose of 100 mcg/hr\n\nLow dose fentanyl PCA', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group / Standard of Care', 'description': '* IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain\n* (Bolus dose can be titrated up in 25 mcg increments if necessary)\n* Maximum dose of 100 mcg/hr\n\nStandard IV fentanyl bolus'}, {'id': 'OG001', 'title': 'Low Dose IV Fentanyl PCA', 'description': '* Initially: 10 mcg demand dose every 12 minutes\n* No initial bolus and no continuous infusion\n* Demand dose increased 10 mcg every 12 minutes if necessary\n* Maximum dose of 100 mcg/hr\n\nLow dose fentanyl PCA'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '4 days', 'description': 'Pain score 0-10. 0 represented no pain and 10 worst pain', 'calculatePct': False, 'reportingStatus': 'POSTED', 'populationDescription': "Though one subject in the PCA arm completed enrollment, we had insufficient data to perform any comparative analysis. We do no intend to summarize the patient's results."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group / Standard of Care', 'description': '* IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain\n* (Bolus dose can be titrated up in 25 mcg increments if necessary)\n* Maximum dose of 100 mcg/hr\n\nStandard IV fentanyl bolus'}, {'id': 'FG001', 'title': 'Low Dose IV Fentanyl Patient Controlled Analgesia (PCA)', 'description': '* Initially: 10 mcg demand dose every 12 minutes\n* No initial bolus and no continuous infusion\n* Demand dose increased 10 mcg every 12 minutes if necessary\n* Maximum dose of 100 mcg/hr\n\nLow dose fentanyl PCA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group / Standard of Care', 'description': '* IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain\n* (Bolus dose can be titrated up in 25 mcg increments if necessary)\n* Maximum dose of 100 mcg/hr\n\nStandard IV fentanyl bolus'}, {'id': 'BG001', 'title': 'Low Dose IV Fentanyl PCA', 'description': '* Initially: 10 mcg demand dose every 12 minutes\n* No initial bolus and no continuous infusion\n* Demand dose increased 10 mcg every 12 minutes if necessary\n* Maximum dose of 100 mcg/hr\n\nLow dose fentanyl PCA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Inclusion criteria were too strict and therefore we were not able to recruit more patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2013-05-08', 'resultsFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-20', 'studyFirstPostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).', 'timeFrame': '4 days', 'description': 'Pain score 0-10. 0 represented no pain and 10 worst pain'}]}, 'conditionsModule': {'conditions': ['Headaches Associated With Subarachnoid Hemorrhage (SAH)']}, 'descriptionModule': {'briefSummary': "Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18-75\n* Glasgow Coma Scale (GCS) 13 or greater\n* Hunt and Hess grade I, II conditions\n* Admitted within 2 days of initial SAH event \\>6/10 pain on presentation\n\nExclusion Criteria:\n\n* Aphasia\n* Head trauma within the past 30 days\n* Need for craniotomy\n* h/o obstructive sleep apnea or respiratory disease\n* h/o opioid tolerance\n* evidence of vasospasm\n* h/o liver disease'}, 'identificationModule': {'nctId': 'NCT01851720', 'briefTitle': 'Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'NA_00071159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group / Standard of Care', 'description': '* IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain\n* (Bolus dose can be titrated up in 25 mcg increments if necessary)\n* Maximum dose of 100 mcg/hr', 'interventionNames': ['Drug: Standard IV fentanyl bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose IV fentanyl PCA', 'description': '* Initially: 10 mcg demand dose every 12 minutes\n* No initial bolus and no continuous infusion\n* Demand dose increased 10 mcg every 12 minutes if necessary\n* Maximum dose of 100 mcg/hr', 'interventionNames': ['Drug: Low dose fentanyl PCA']}], 'interventions': [{'name': 'Low dose fentanyl PCA', 'type': 'DRUG', 'armGroupLabels': ['Low dose IV fentanyl PCA']}, {'name': 'Standard IV fentanyl bolus', 'type': 'DRUG', 'armGroupLabels': ['Control group / Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}