Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-30 @ 2:04 AM
Study NCT ID:
NCT01123551
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2010-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Resolution rate', 'timeFrame': 'one hour', 'description': 'resolution is defined as VAPS \\<30%.'}], 'secondaryOutcomes': [{'measure': 'rate of side effects', 'timeFrame': 'one hour', 'description': 'Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.'}, {'measure': 'Resolution time', 'timeFrame': 'one hour', 'description': 'Resolution time is defined as the time between the starting of the protocol and pain decrease to a Visual Analog Scale less than 30%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nebulized morphine', 'Intravenous morphine', 'Post traumatic', 'Pain', 'Emergency department'], 'conditions': ['Post Traumatic Pain']}, 'descriptionModule': {'briefSummary': 'In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults.\n\nIt offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%\n* Age between 8 and 50 years.\n\nExclusion Criteria:\n\n* Glasgow coma scale (GCS)\\< 14,\n* Severe injury ,\n* Hypotension : blood systolic pressure \\< 90 mmhg,\n* Bradypnea \\< 12 cpm or SaO2\\< 90%,\n* Chronic pain treatment,\n* Aspirin or paracetamol treatment within 6 hours of emergency presentation,\n* Nasal trauma, rhinitis, nasal obstruction,\n* Incapacity to cooperate,\n* Opiate allergy,\n* Drug addiction,\n* Pregnancy, breast feeding,\n* Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)'}, 'identificationModule': {'nctId': 'NCT01123551', 'briefTitle': 'Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)', 'orgStudyIdInfo': {'id': 'Morphine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized Morphine', 'description': 'After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .', 'interventionNames': ['Drug: nebulized morphine', 'Drug: Intravenous morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous morphine', 'description': "After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS \\>30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS \\>30%).", 'interventionNames': ['Drug: Intravenous morphine']}], 'interventions': [{'name': 'nebulized morphine', 'type': 'DRUG', 'description': 'After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .', 'armGroupLabels': ['Nebulized Morphine']}, {'name': 'Intravenous morphine', 'type': 'DRUG', 'description': "After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS \\>30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS \\>30%).", 'armGroupLabels': ['Intravenous morphine', 'Nebulized Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Monastir Governorate', 'country': 'Tunisia', 'facility': 'Fattouma Bourguiba University Hospital', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}