Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 6:21 AM
Study NCT ID:
NCT01129934
Status:
UNKNOWN
Last Update Posted:
2010-05-25
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-23', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-05-23', 'lastUpdatePostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': 'Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)', 'description': 'Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.'}], 'secondaryOutcomes': [{'measure': 'Ambulatory status', 'timeFrame': 'Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)', 'description': 'Most patients who suffer from acute LBP are in severe pain and are unable to ambulate. The ambulatory status of every patient (e.g., able to walk independently, using a can, wheelchair, laying down and unable to sit or stand up)will be recorded before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low Back Pain,', 'Emergency medicine,', 'Promethazine,', 'Morphine,', 'Pain relief'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.', 'detailedDescription': "Acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. Numerous medication options are available for acute LBP relief,each class of medication has its associated benefits and harms.Controversy remains regarding the optimal analgesic treatment.Anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ED setting.\n\nPromethazine is a first-generation H1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. It has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.It may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ED."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An indication for opioid analgesia based in the ED (i.e. severe pain \\> 70mm on a 100mm VAS)\n2. Age between 18-65 years\n3. American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease\n4. Systolic blood pressure higher than 90 mmHg on admission\n5. Willingness and ability to provide an informed consent\n6. No known hypersensitivity to the medication used.\n\nExclusion Criteria:\n\n1. Pregnant women\n2. Patients who can not be under adult supervision following discharge from the emergency department.'}, 'identificationModule': {'nctId': 'NCT01129934', 'briefTitle': 'Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department', 'orgStudyIdInfo': {'id': 'TASMC-09-PH-701-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morphine-Promethazine', 'description': 'Pain relief by administration of morphine-promethazine combination', 'interventionNames': ['Drug: Morphine-Promethazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'morphine', 'description': 'pain relief by administration of morphine', 'interventionNames': ['Drug: morphine']}], 'interventions': [{'name': 'Morphine-Promethazine', 'type': 'DRUG', 'otherNames': ['morphine-phenergan'], 'description': 'administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline', 'armGroupLabels': ['Morphine-Promethazine']}, {'name': 'morphine', 'type': 'DRUG', 'otherNames': ['morphine as a single drug'], 'description': 'Administration of intravenous morphine 0.1 mg/kg', 'armGroupLabels': ['morphine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'Ofir Uri, M.D', 'role': 'CONTACT', 'email': 'ofiruri@gmail.com', 'phone': '972-52-4262285'}, {'name': 'Pinchas Halpern, M.D', 'role': 'CONTACT', 'email': 'dr_halperin@tasmc.health.gov.il', 'phone': '972-52-4266681'}, {'name': 'Pinchas Halpern, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ofir Uri, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amir Shapira, M.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Ofir Uri, M.D', 'role': 'CONTACT', 'email': 'ofiruri@gmail.com', 'phone': '972-52-4262285'}], 'overallOfficials': [{'name': 'Pinchas Halpern, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Tel-Aviv Medical Center, Tel-Aviv University, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Halpern Pinchas, Chair, Department of Emergency Medicine', 'oldOrganization': 'Tel-Aviv Sourasky Medical Center'}}}}