Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 6:02 PM
Study NCT ID:
NCT02912195
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Lidocaine Versus Morphine for Severe Pain in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aherring@alamedahealthsystem.org', 'phone': '510 437-8356', 'title': 'Andrew Herring', 'organization': 'Alameda Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was limited by a small sample size and lack of blinding.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine', 'otherNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perioral numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '6.8'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 60 minutes', 'description': 'Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '9.0'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '9.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 10 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '8.4'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '7.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 20 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '8.1'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '7.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 30 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '7.5'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 40 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score (NRS 0-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.1'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 50 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 10 Minutes Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.8'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 10 minutes', 'description': 'Pain NRS at 0 minutes minus pain NRS at 10 minutes', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 20 Minutes Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '2.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 20 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 20 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 30 Minutes Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '3.0'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 30 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 30 minutes NRS is a scale ranging from 0, no pain, to 10 worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 40 Minutes Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.1'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 40 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 40 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 50 Minutes Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '5.0'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 50 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 50 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 60 Minutes Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '5.7'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '5.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 60 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 60 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Rescue Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 20 and 40 minutes', 'description': 'The percentage of patients requiring rescue IV morphine at 20 and 40 minutes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 minutes', 'description': 'The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in the intravenous lidocaine arm did not answer the question.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-60 minutes', 'description': 'Participants will be observed for the following adverse events and side effects: seizure, bradyarrhythmias, hyper or hypotension, perioral numbness, tinnitus, metallic taste, other, hypotension, hypoxia, nausea, vomiting, itching, or other side effects. Participants have the opportunity to report other side effects during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'FG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes'}, {'id': 'BG001', 'title': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.\n\nIntravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '36.5', 'upperLimit': '59.5'}, {'value': '45.5', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '59.5'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '59.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2016-09-20', 'resultsFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-24', 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score (NRS 0-10)', 'timeFrame': 'At 60 minutes', 'description': 'Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Pain Score (NRS 0-10)', 'timeFrame': 'At 10 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.'}, {'measure': 'Pain Score (NRS 0-10)', 'timeFrame': 'At 20 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.'}, {'measure': 'Pain Score (NRS 0-10)', 'timeFrame': 'At 30 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.'}, {'measure': 'Pain Score (NRS 0-10)', 'timeFrame': 'At 40 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.'}, {'measure': 'Pain Score (NRS 0-10)', 'timeFrame': 'At 50 minutes', 'description': 'Pain score recorded on the numeric rating scale 0-10.'}, {'measure': 'Pain Relief at 10 Minutes Compared to Baseline.', 'timeFrame': 'At 10 minutes', 'description': 'Pain NRS at 0 minutes minus pain NRS at 10 minutes'}, {'measure': 'Pain Relief at 20 Minutes Compared to Baseline.', 'timeFrame': 'at 20 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 20 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.'}, {'measure': 'Pain Relief at 30 Minutes Compared to Baseline.', 'timeFrame': 'at 30 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 30 minutes NRS is a scale ranging from 0, no pain, to 10 worst pain.'}, {'measure': 'Pain Relief at 40 Minutes Compared to Baseline.', 'timeFrame': 'At 40 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 40 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.'}, {'measure': 'Pain Relief at 50 Minutes Compared to Baseline.', 'timeFrame': 'At 50 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 50 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.'}, {'measure': 'Pain Relief at 60 Minutes Compared to Baseline.', 'timeFrame': 'At 60 minutes', 'description': 'Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 60 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.'}, {'measure': 'Number of Participants Requiring Rescue Medications', 'timeFrame': 'At 20 and 40 minutes', 'description': 'The percentage of patients requiring rescue IV morphine at 20 and 40 minutes'}, {'measure': 'Patient Satisfaction', 'timeFrame': '60 minutes', 'description': 'The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"'}, {'measure': 'Number of Participants Reporting Adverse Events', 'timeFrame': '0-60 minutes', 'description': 'Participants will be observed for the following adverse events and side effects: seizure, bradyarrhythmias, hyper or hypotension, perioral numbness, tinnitus, metallic taste, other, hypotension, hypoxia, nausea, vomiting, itching, or other side effects. Participants have the opportunity to report other side effects during the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider chosen dose of IV morphine for the treatment of severe pain in the emergency department.\n\nStudy design: Open-label, randomized controlled pilot study.', 'detailedDescription': 'Objective: The purpose of this pilot study is to determine the analgesic efficacy of intravenous lidocaine versus morphine for the treatment of severe pain in the emergency department (ED).\n\nStudy design: Open-label, randomized, controlled pilot trial. Participants: Investigators and research assistants will recruit patients ≥18 years old with severe pain (NRS ≥7) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed and 32 patients will be enrolled.\n\nIntervention: After a trained research assistant obtains written informed consent, eligible participants will be randomized to the intravenous lidocaine or morphine arms of the study. In the intravenous lidocaine arm, patients will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg). In the morphine arm, the ED provider will choose an appropriate dose of morphine for the patient. At 20 and 40 minutes, the participants will be asked "Would you like additional pain medication?". Participants responding in the affirmative will receive morphine 4 mg IV.\n\nData collection: The trained research assistant will collect data on the patients\' pain scores, side effects, and rescue morphine.\n\nStatistical analysis: Investigators will perform descriptive statistics and compare pain scores and pain relief at each time point with unpaired t-tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has severe pain (NRS ≥7)\n* Subject has anticipated ED stay of ≥1 hour\n\nExclusion Criteria:\n\n* High acuity trauma patients\n* Patients deemed to critically ill by ED provider\n* Active psychosis\n* Pregnancy\n* History of heart block or bradycardia\n* Allergy to lidocaine or amide type local anesthetic\n* History of seizures'}, 'identificationModule': {'nctId': 'NCT02912195', 'briefTitle': 'Intravenous Lidocaine Versus Morphine for Severe Pain in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Alameda Health System'}, 'officialTitle': 'Intravenous Lidocaine Versus Provider Chosen Dose of Morphine for the Treatment of Severe Pain in the Emergency Department: An Open-label Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': '00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous lidocaine', 'description': 'Participants will receive IV lidocaine (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \\<50kg, 100 mg if 50 - 100 kg, and 150 mg if \\>100 kg) in a 100 mL normal saline minibag.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.', 'interventionNames': ['Drug: Intravenous lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'ED provider will choose an appropriate dose of intravenous morphine for the patient.\n\nAt 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.', 'interventionNames': ['Drug: Intravenous morphine']}], 'interventions': [{'name': 'Intravenous lidocaine', 'type': 'DRUG', 'otherNames': ['lignocaine', 'Xylocaine'], 'description': 'Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes', 'armGroupLabels': ['Intravenous lidocaine']}, {'name': 'Intravenous morphine', 'type': 'DRUG', 'otherNames': ['duramorph'], 'description': 'Emergency department provider chooses appropriate dose of intravenous morphine', 'armGroupLabels': ['Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alameda Health System, Highland Hospital', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Andrew Herring, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alameda Health System, Highland Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alameda Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Eben Clattenburg', 'investigatorAffiliation': 'Alameda Health System'}}}}