Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT00882960
Status:
UNKNOWN
Last Update Posted:
2011-05-04
First Post:
2009-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Fentanyl for Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-03', 'studyFirstSubmitDate': '2009-04-16', 'studyFirstSubmitQcDate': '2009-04-16', 'lastUpdatePostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary measure will be the change recorded in patients subjective pain using a standardized scale', 'timeFrame': 'Pain will be assessed at 5 and 10 minutes post administration of Fentanyl'}], 'secondaryOutcomes': [{'measure': 'Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl', 'timeFrame': '5 and 10 minutes post medication delivery'}]}, 'conditionsModule': {'keywords': ['pre-hospital', 'intra-nasal fentanyl', 'patients requiring analgesia'], 'conditions': ['Trauma', 'Pain']}, 'descriptionModule': {'briefSummary': 'Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.', 'detailedDescription': 'Currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. Often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. The lack of delivery method than prevents the patients from receiving humane and indicated pain medication. In patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions.\n\nThe goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. The medication to be administered will be Fentanyl, a previously established and approved pre-hospital analgesic medication. As with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. Specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration\n\nThe study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. We will ask participants to quantify their pain using the Wong-Baker FACES pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. The drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons who meet the current State of Michigan County of Oakland and County of Genesee pre-hospital pain requiring analgesia.\n* Examples of these patients would be those with fractures, kidney stones, or traumatic injuries, burns.\n\nExclusion Criteria:\n\n* Patients who have compromised nasal pharynx such as those who have obvious fractures or epistaxis.\n* Additionally patients who are in the supine position for cervical spine immobilization will be excluded.'}, 'identificationModule': {'nctId': 'NCT00882960', 'briefTitle': 'Intranasal Fentanyl for Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Genesys'}, 'officialTitle': 'Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management', 'orgStudyIdInfo': {'id': '104904-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'patients who are randomized to receive intravenous fentanyl for control of their pain', 'interventionNames': ['Drug: intravenous fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'patients who are randomized to receive intra-nasal fentanyl for control of their pain', 'interventionNames': ['Drug: intra-nasal fentanyl']}], 'interventions': [{'name': 'intravenous fentanyl', 'type': 'DRUG', 'description': 'An IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma.', 'armGroupLabels': ['1']}, {'name': 'intra-nasal fentanyl', 'type': 'DRUG', 'description': 'a mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ryan Kirby, M.D.', 'role': 'CONTACT', 'email': 'ryan.kirby@genesys.org', 'phone': '810-606-5933'}, {'name': 'Ryan P Kirby, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stuart Etengoff, D.O.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alan R Janssen, D.O.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}], 'centralContacts': [{'name': 'Ryan P Kirby, M.D.', 'role': 'CONTACT', 'email': 'ryan.kirby@genesys.org', 'phone': '810-606-5933'}], 'overallOfficials': [{'name': 'Alan R Janssen, D.O.', 'role': 'STUDY_CHAIR', 'affiliation': 'Director of Emergency Medicine Residency, Genesys Regional Medical Center'}, {'name': 'Ryan P Kirby, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident physician, Genesys Regional Medical Center'}, {'name': 'Stuart Etengoff, D.O.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genesys', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Ryan Kirby, M.D.', 'oldOrganization': 'Genesys Regional Medical Center'}}}}