Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 3:01 PM
Study NCT ID:
NCT03080350
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2016-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-01', 'studyFirstSubmitDate': '2016-12-04', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain - Relief', 'timeFrame': '1 hour', 'description': 'Pain - Relief of 2 points on a 11 items pain scale (0 = non pain; 10 = unbearable pain)'}], 'secondaryOutcomes': [{'measure': 'Practicability / handling of the two dosage forms of fentanyl in emergencies', 'timeFrame': '1 hour', 'description': 'Practicability / handling'}, {'measure': 'Patient comfort', 'timeFrame': '1 hour', 'description': '5 items Labert Scale'}, {'measure': 'Adverse drug effects', 'timeFrame': '1 hour', 'description': 'such as pruritus, nausea, dizziness'}, {'measure': 'SpO2 (%)', 'timeFrame': '1 hour', 'description': 'SpO2 \\< 92%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fentanyl', 'Transmucosal administration', 'Endovenous administration', 'Pain therapy', 'Mountain emergency medicine'], 'conditions': ['Acute Pain Due to Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the non-inferiority of the efficacy for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope', 'detailedDescription': 'Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough cancer pain relief in oncologic patients.\n\nThe immediate (less than 10 minutes) effect and the ease of administration of sublingual fentanyl is a feasible drug administration for immediate analgesia in remote areas such as mountain rescue missions eg. the slope.\n\nPatients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev.\n\nSafety issues like control of vital signs will be warranted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma on the limbs with a pain score of 4 or more on the slope\n* ASA I - II\n\nExclusion Criteria:\n\n* children (\\< 18 years)\n* cognitive impairment: brain injury, intoxication, analgesia\n* weight under 50 kg and more than 100 kg\n* other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;\n* chronic analgesic use or misuse\n* allergy\n* fear of needles\n* pregnancy\n* speech difficulties'}, 'identificationModule': {'nctId': 'NCT03080350', 'briefTitle': 'Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope', 'organization': {'class': 'OTHER', 'fullName': "Azienda Sanitaria dell'Alto Adige"}, 'officialTitle': 'Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope - a Double-blind Randomized Prospective Study', 'orgStudyIdInfo': {'id': 'SABES Pain 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl sublingual + Placebo ev', 'description': 'Fentanyl 100 µg sublingual in acute sever pain + NaCl 0,9% endovenous to mimic fentanyl ev', 'interventionNames': ['Drug: Fentanyl sublingual', 'Drug: Placebo ev']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl ev + Placebo sublingual', 'description': 'Fentanyl ev in acute sever pain + Sugar pill manufactured to mimic fentanyl sublingual', 'interventionNames': ['Drug: Fentanyl ev', 'Drug: Placebo sublingual']}], 'interventions': [{'name': 'Fentanyl sublingual', 'type': 'DRUG', 'otherNames': ['Abstral'], 'description': 'Fentanyl sublingual', 'armGroupLabels': ['Fentanyl sublingual + Placebo ev']}, {'name': 'Fentanyl ev', 'type': 'DRUG', 'description': 'Fentanyl ev', 'armGroupLabels': ['Fentanyl ev + Placebo sublingual']}, {'name': 'Placebo sublingual', 'type': 'DRUG', 'description': 'Placebo sublingual', 'armGroupLabels': ['Fentanyl ev + Placebo sublingual']}, {'name': 'Placebo ev', 'type': 'DRUG', 'description': 'Placebo - NaCL 0,9% ev', 'armGroupLabels': ['Fentanyl sublingual + Placebo ev']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39031', 'city': 'Bruneck', 'country': 'Italy', 'facility': 'Skiresort - Kronplatz', 'geoPoint': {'lat': 46.79942, 'lon': 11.93429}}], 'overallOfficials': [{'name': 'Rosmarie Oberhammer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Südtiroler Sanitätsbetrieb - Bruneck Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Azienda Sanitaria dell'Alto Adige", 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Mountain Emergency Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Elisabeth Gruber', 'investigatorAffiliation': "Azienda Sanitaria dell'Alto Adige"}}}}