Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 10:48 PM
Study NCT ID:
NCT01311895
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2011-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'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': 'achang3@yahoo.com', 'phone': '718-920-6626', 'title': 'Dr. Andrew Chang', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '60 minutes', 'description': "The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.\n\nH2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).\n\n1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)", 'eventGroups': [{'id': 'EG000', 'title': 'H2O (2 mg IV Hydromorphone)', 'description': '2 mg IV hydromorphone\n\nH2O: 2 mg IV hydromorphone', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 56, 'seriousNumAtRisk': 166, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)', 'description': '1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"\n\n1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 53, 'seriousNumAtRisk': 168, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Administration of naloxone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Oxygen saturation <95%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulse rate <50 beats/min', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Systolic blood pressure <90 mmHg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Nausea', 'notes': 'excludes patients who were nauseated or vomiting before receiving opioids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'notes': 'excludes patients who were nauseated or vomiting before receiving opioids in the ED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Satisfactory Pain Management at 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'H2O (2 mg IV Hydromorphone)', 'description': '2 mg IV hydromorphone administered over 2-3 minutes as initial dose\n\nH2O: 2 mg IV hydromorphone'}, {'id': 'OG001', 'title': '1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)', 'description': '1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"\n\n1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 minutes', 'description': 'The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.\n\nH2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).\n\n1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"}, {'type': 'SECONDARY', 'title': 'Mean Change in Pain Intensity From Baseline to 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'H2O (2 mg IV Hydromorphone)', 'description': '2 mg IV hydromorphone administered over 2-3 minutes as initial dose\n\nH2O: 2 mg IV hydromorphone'}, {'id': 'OG001', 'title': '1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)', 'description': '1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"\n\n1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.\n\nH2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).\n\n1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'H2O (2 mg IV Hydromorphone)', 'description': '2 mg IV hydromorphone administered over 2-3 minutes as initial dose\n\nH2O: 2 mg IV hydromorphone'}, {'id': 'OG001', 'title': '1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)', 'description': '1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"\n\n1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 minutes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.\n\nH2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).\n\n1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'H2O (2 mg IV Hydromorphone)', 'description': '2 mg IV hydromorphone\n\nH2O: 2 mg intravenous (IV) hydromorphone'}, {'id': 'FG001', 'title': '1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)', 'description': '1 mg intravenous (IV) hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"\n\n1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'H2O (2 mg IV Hydromorphone)', 'description': '2 mg IV hydromorphone\n\nH2O: 2 mg IV hydromorphone'}, {'id': 'BG001', 'title': '1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)', 'description': '1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"\n\n1+1: 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '52'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '50'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000', 'lowerLimit': '165', 'upperLimit': '210'}, {'value': '186', 'groupId': 'BG001', 'lowerLimit': '170', 'upperLimit': '219'}, {'value': '184', 'groupId': 'BG002', 'lowerLimit': '165', 'upperLimit': '219'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Location of pain', 'classes': [{'title': 'Abdomen', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pain intensity', 'classes': [{'title': '3-7', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable").', 'unitOfMeasure': 'Participants'}, {'title': 'Nauseated or vomited before receiving opioids in the Emergency Department (ED)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.\n\nH2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).\n\n1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2011-03-04', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-20', 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Satisfactory Pain Management at 60 Minutes', 'timeFrame': '60 minutes', 'description': 'The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Pain Intensity From Baseline to 60 Minutes', 'timeFrame': '60 minutes', 'description': 'Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.'}, {'measure': 'Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes', 'timeFrame': '60 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute', 'pain', 'emergency department', 'hydromorphone'], 'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED).\n2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.\n3. ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids\n\nExclusion Criteria:\n\n1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.\n2. Prior adverse reaction to opioids.\n3. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.\n4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.\n5. Systolic Blood Pressure \\<90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.\n6. Oxygen saturation \\< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.\n7. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.\n8. CO2 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:\n\n * All patients who have a history of chronic obstructive pulmonary disease (COPD)\n * All patients who report a history of asthma together with greater than a 20 pack-year smoking history\n * All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation"}, 'identificationModule': {'nctId': 'NCT01311895', 'briefTitle': 'Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone', 'orgStudyIdInfo': {'id': 'MMC 10-07-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H2O', 'description': '2 mg IV hydromorphone administered over 2-3 minutes as initial dose', 'interventionNames': ['Drug: H2O']}, {'type': 'EXPERIMENTAL', 'label': '1+1', 'description': '1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"', 'interventionNames': ['Drug: 1+1']}], 'interventions': [{'name': 'H2O', 'type': 'DRUG', 'otherNames': ['Dilaudid'], 'description': '2 mg IV hydromorphone', 'armGroupLabels': ['H2O']}, {'name': '1+1', 'type': 'DRUG', 'otherNames': ['Dilaudid'], 'description': '1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"', 'armGroupLabels': ['1+1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center Moses Division Emergency Department', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrew Chang, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}