Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-04 @ 12:15 PM
Study NCT ID:
NCT02289261
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], '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'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-10', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption (mg)', 'timeFrame': '24 hours', 'description': 'cumulative morphine consumption for 24 hours'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '24 hours', 'description': 'visual analog scale to assess pain degree'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pain', 'Morphine', 'Dexmedetomidine'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '22546966', 'type': 'BACKGROUND', 'citation': 'Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.'}, {'pmid': '18987053', 'type': 'RESULT', 'citation': 'Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dexmedetomidine added to morphine is effective in the treatment of chronic cancer pain.', 'detailedDescription': "We conduct the study in Cukurova University Faculty of Medicine Research Hospital after obtaining ethics committee approval and patient's informed consent. Patients with cancer pain are allocated into two group to receive Patient Controlled Analgesia with morphine or morphine plus dexmedetomidine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with chronic cancer pain\n* between 20-80 years old age\n\nExclusion Criteria:\n\n* the presence of severe systemic disease(cardiac, pulmonary, hepatic or renal)\n* psychiatric or neurologic disease\n* unable to communicate verbally\n* nausea and vomiting\n* patient's refusal"}, 'identificationModule': {'nctId': 'NCT02289261', 'briefTitle': 'A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain', 'orgStudyIdInfo': {'id': 'MDICP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval', 'interventionNames': ['Drug: Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine plus dexmedetomidine', 'description': 'Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval', 'interventionNames': ['Drug: Morphine plus dexmedetomidine']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['morphine sulphate'], 'description': 'Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval', 'armGroupLabels': ['Control']}, {'name': 'Morphine plus dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Morphine sulphate plus dexmedetomidine'], 'description': 'Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval', 'armGroupLabels': ['Morphine plus dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01130', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University Faculty of Medicine Research Hospital', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Selcuk Gök, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cukurova University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ersel Gulec', 'investigatorFullName': 'Ersel GULEC', 'investigatorAffiliation': 'Cukurova University'}}}}