Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06051227
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], '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'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'C000629870', 'term': 'Esketamine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 608}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain score as measured with Numeric Rating Scale (NRS)', 'timeFrame': '10 minutes after first drug administration', 'description': "NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'"}], 'secondaryOutcomes': [{'measure': 'Change in pain score as measured with NRS', 'timeFrame': '20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)', 'description': "NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'"}, {'measure': 'Relative change in pain score as measured with NRS', 'timeFrame': '10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)', 'description': "NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'"}, {'measure': 'Number of subjects requiring a second dose of study medication', 'timeFrame': '10 and 20 minutes after first drug administration', 'description': 'If the patient requires additional analgesia, study medication can be repeated once'}, {'measure': 'Patient satisfaction with pre-hospital analgesia', 'timeFrame': 'Time of arrival at the hospital (expected within 30 minutes after first drug administration)', 'description': "Patient satisfaction is measured using an 11 point Likert scale ranging from 0 to 10, where 0 means 'extremely unsatisfactory' and 10 means 'extremely satisfactory'"}, {'measure': 'Number of patients experiencing adverse events', 'timeFrame': 'Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)', 'description': 'Including side effects'}, {'measure': 'Number of patients requiring unblinding', 'timeFrame': 'Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)', 'description': 'E.g. because of treatment failure or side effects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesics', 'Ketanest', 'Administration, intranasal', 'Administration, intravenous', 'Pain management', 'Drug-Related Side Effects and Adverse Reactions', 'Anesthetics'], 'conditions': ['Acute Pain Due to Trauma', 'Analgesia', 'Fentanyl', 'Esketamine', 'Emergency Medical Services']}, 'referencesModule': {'references': [{'pmid': '40420189', 'type': 'DERIVED', 'citation': 'de Grunt MN, Risvanoglu N, Siegers JA, Kroon MAGM, Merkus MP, Hollmann MW, Ridderikhof ML, Weenink RP. Fentanyl or esketamine for traumatic pain (FORE-PAIN) trial: study protocol for a double-blind multi-arm randomized non-inferiority trial. Trials. 2025 May 26;26(1):172. doi: 10.1186/s13063-025-08869-9.'}]}, 'descriptionModule': {'briefSummary': 'Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration.\n\nThe FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* pain has been caused by a trauma (any trauma mechanism) that occurred on the same day\n* Emergency Medical Services personnel determines that administration of a strong opioid or esketamine for analgesia is required\n* patient will be transported to a hospital\n\nExclusion Criteria:\n\n* (estimated) weight \\<40 or \\>100 kg\n* subject does not understand Dutch or English\n* inability to report pain score\n* inability to give IN or IV medication\n* known severe cardiovascular disease\n* pre-eclampsia\n* Glasgow Coma Scale score \\< 11\n* subject is known to have previously declined participation in medical research'}, 'identificationModule': {'nctId': 'NCT06051227', 'acronym': 'FORE-PAIN', 'briefTitle': 'Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial', 'orgStudyIdInfo': {'id': 'FP-2023'}, 'secondaryIdInfos': [{'id': '2022-500176-63-00', 'type': 'OTHER', 'domain': 'EU Clinical Trials Information System'}, {'id': 'U1111-1287-7486', 'type': 'OTHER', 'domain': 'ICTRP'}, {'id': '2022-000039-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl IV', 'description': 'Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intravenous Initial dose: 1 ug/kg Second dose (if required): 0.6ug/kg', 'interventionNames': ['Drug: Fentanyl Citrate']}, {'type': 'EXPERIMENTAL', 'label': 'Fentanyl IN', 'description': 'Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intranasal using nasal atomizer Initial dose: 1.25 ug/kg to a maximum of 100ug Second dose (if required): 1ug/kg to a maximum total dose of 2ug/kg', 'interventionNames': ['Drug: Fentanyl Citrate']}, {'type': 'EXPERIMENTAL', 'label': 'Esketamine IV', 'description': 'Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection/infusion Administration: intravenous Initial dose: 0.2mg/kg Second dose (if required): 0.12mg/kg', 'interventionNames': ['Drug: Esketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Esketamine IN', 'description': 'Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection/infusion Administration: intranasal using a nasal atomizer Initial dose: 0.625mg/kg to a maximum of 50mg Second dose (if required): 0.5mg/kg to a maximum total dose of 1mg/kg', 'interventionNames': ['Drug: Esketamine']}], 'interventions': [{'name': 'Fentanyl Citrate', 'type': 'DRUG', 'description': 'Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal', 'armGroupLabels': ['Fentanyl IN', 'Fentanyl IV']}, {'name': 'Esketamine', 'type': 'DRUG', 'description': 'Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal', 'armGroupLabels': ['Esketamine IN', 'Esketamine IV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Midas de Grunt, MD', 'role': 'CONTACT', 'email': 'forepain@amsterdamumc.nl'}], 'facility': 'Ambulance Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Robert P Weenink, PhD', 'role': 'CONTACT', 'email': 'forepain@amsterdamumc.nl', 'phone': '+31 205669111'}], 'overallOfficials': [{'name': 'Markus W Hollmann, Prof. dr. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': "Metadata are published before locking of the database. The final data are published at the time of the journal article's publication.", 'ipdSharing': 'YES', 'description': 'Metadata and final data will be published. Conditions for reuse apply.', 'accessCriteria': 'Conditions for reuse of data are described in the patient information folder. Access to the data can be granted by the Principal Investigator based on these criteria.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stichting ZiektekostenVerzekering Krijgsmacht', 'class': 'UNKNOWN'}, {'name': 'Ambulance Amsterdam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Weenink', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}