Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02485418
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deryk.walsh@utsouthwestern.edu', 'phone': '2144566393', 'title': 'Deryk Walsh, MD', 'organization': 'University of Texas Southwestern'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'description': 'Adverse events were collected by nursing at time of infusion and 24 and 48 hours post infusion by phone communication.\n\nAll-Cause Mortality was not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Propofol Infusion', 'description': 'All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes\n\nPropofol: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 0, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'nausea', 'notes': 'Patients with nausea with peripheral intravenous line insertion, prior to infusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'emesis, abdominal pain & fever', 'notes': 'patient with emesis, abdominal pain and fever at 24 hour follow-up. Patient seen in the ED 1 week prior to infusion with similar symptoms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Headache Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol Infusion', 'description': 'All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes\n\nPropofol: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of propofol infusion (between 5 and 60 minutes)', 'description': 'Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, analysis of data based on patients completing 60 minute infusion of propofol'}, {'type': 'SECONDARY', 'title': 'NPRS Pain Scores at 24 and 48 Hours Post Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol Infusion', 'description': 'All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes\n\nPropofol: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': '24 hours post infusion', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': '48 hours post infusion', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion', 'description': 'For subjects who experience a change in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain.', 'unitOfMeasure': 'Pain Score 0-10 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Propofol Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Dose of Propofol Administered (mg/kg)', 'description': 'Each patient enrolled received the protocol dosing of propofol as outlined. All patients received scheduled 2.1 mg/kg over 60 minutes as per protocol, except for one patient who was discontinued due to complete resolution of headache. Considered outlier.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Total dose of propofol administered (mg/kg)', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propofol Infusion', 'description': 'All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes\n\nPropofol: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from two headache clinic populations', 'preAssignmentDetails': 'Forty patients met criteria and were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Propofol Infusion', 'description': 'All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes\n\nPropofol: Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '1.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', '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': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '40 patients screened and 2 patients excluded and baseline characteristics not included'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-06', 'size': 960847, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-29T16:06', 'hasProtocol': True}, {'date': '2023-12-29', 'size': 127756, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-29T15:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2015-06-04', 'resultsFirstSubmitDate': '2023-12-29', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-08', 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Headache Pain Score', 'timeFrame': 'Duration of propofol infusion (between 5 and 60 minutes)', 'description': 'Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes'}], 'secondaryOutcomes': [{'measure': 'NPRS Pain Scores at 24 and 48 Hours Post Infusion', 'timeFrame': 'Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion', 'description': 'For subjects who experience a change in pain score or who report resolution from headache symptoms, duration of analgesia up to 48 hours after treatment,characterized by NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain.'}, {'measure': 'Total Propofol Dose', 'timeFrame': '60 minutes', 'description': 'Total dose of propofol administered (mg/kg)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine Headache']}, 'descriptionModule': {'briefSummary': 'Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to:\n\n1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches\n2. Evaluate effective and safe dosing limits in pediatric populations\n3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent\n\nEndpoints for the study will be:\n\n1. Number of enrolled patients\n2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under the guidance and supervision of a board certified pediatric anesthesiologist with the appropriate monitoring equipment and readily available emergency equipment. Investigators hope to demonstrate more rapid improvement and decreased side-effect as compared to standard care.', 'detailedDescription': 'The aim of this prospective study is to evaluate the efficacy and safety of propofol administration in a hospital setting, as an abortive medication for children aged 7-18 with migraines.\n\nPrimary outcome:\n\nBased on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.\n\nSecondary outcomes:\n\n* Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)\n* Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)\n* Total propofol dose based on weight.\n\nPrior to initiation of DHE infusion, the subjects will receive sub-anesthetic doses of propofol infusion:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes. The propofol infusion will be terminated if:\n\n* The patient has no pain, or greater than 50% reduction in pain scores as compared to the pretreatment pain score\n* After completing 40 minutes of propofol infusion at 40 mcg/kg/min irrespective of the pain score\n* If the anesthesiologist feels cardio-pulmonary depression, airway obstruction or over sedation (Ramsay Sedation Score greater than 3)has occurred\n\nIf the propofol infusion is effective in resolving headache symptoms, then subjects will be monitored for at least 30 minutes after termination of infusion. Outpatient subjects would then be discharged home; inpatient subjects would resume standard care treatment.\n\nIf propofol infusion is not successful in resolving headache, then the subjects will proceed with DHE infusion per standard of care. If the subject still has no relief, the study investigators will discuss further options with the subject and parents, including hospital admission for further therapy for outpatient subjects.\n\nFor all subjects who receive propofol infusion, follow-up will occur at 24 and 48 hours via phone call to evaluate headache status and recover information on headache symptoms and side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)\n* The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache\n* Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale\n* Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale\n* Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care\n* Patients age 7-18 years old\n* Gender: both male and female\n* Appropriate fasting interval as per ASA guidelines\n\nExclusion Criteria:\n\n* No long acting triptan therapy within 24 hours\n* No shorter acting triptan therapy within 6 hours\n* No ergot alkaloid derivatives within the last 24 hours\n* No opioid within 2 hours\n* No NSAID or acetaminophen within 1 hour of infusion\n* Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates\n* Headache not consistent with subject's headache history needing further work-up\n* Headache duration less than 24 hours\n* Subjects in which an intravenous line could not be secured\n* Subjects with history of significant reflux or hiatal hernia\n* Subjects with history of significant cardio pulmonary disorders\n* Patient not fasting as per ASA guidelines"}, 'identificationModule': {'nctId': 'NCT02485418', 'acronym': 'Propofol2014', 'briefTitle': 'Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients', 'orgStudyIdInfo': {'id': 'STU 042014-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol infusion', 'description': 'All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:\n\n20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.', 'armGroupLabels': ['Propofol infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Health Children's Medical Center Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Deryk Walsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Medical Center Dallas"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Deryk Walsh', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}