Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:48 AM
Study NCT ID:
NCT07314450
Status:
RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-05', 'size': 317507, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-14T07:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction via 5-point Likert Scale', 'timeFrame': 'Immediately after the procedure', 'description': 'Patient satisfaction with the sedation regimen and treatment will be assessed using a 5-point Likert Scale, which ranges from 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores will reflect a better outcome.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}, {'measure': 'Incidence of procedural amnesia', 'timeFrame': 'Immediately after the procedure', 'description': 'Incidence of procedural amnesia will be assessed as a patient-reported outcome. Each case will be recorded as present or absent. Higher incidence reflects a better outcome.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}, {'measure': 'Incidence of dissociative experience during treatment', 'timeFrame': 'Immediately after the procedure', 'description': 'Incidence of dissociative experience during the treatment procedure will be assessed as a patient- and physician-reported outcome. Each case will be recorded as present or absent and categorized as a good or bad experience. A higher incidence of bad experiences will reflect a worse outcome, whereas a higher incidence of good experiences will reflect a better outcome.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}], 'primaryOutcomes': [{'measure': 'Patient satisfaction via Numerical Rating Scale', 'timeFrame': 'Immediately after the procedure', 'description': 'Patient satisfaction with the procedural sedation regimen will be assessed using the 11-point Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}], 'secondaryOutcomes': [{'measure': 'Re-call of maximum pain intensity', 'timeFrame': 'Immediately after the procedure', 'description': 'Re-call of the maximum pain intensity during the treatment procedure will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores will reflect a worse outcome.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}, {'measure': 'Patient satisfaction via Short Assessment of Patient Satisfaction', 'timeFrame': 'Immediately after the procedure', 'description': 'Patient satisfaction with the sedation regimen and treatment will be assessed using the Short Assessment of Patient Satisfaction, which consists of 7 items, each scored from 0 to 4, yielding a total score ranging from 0 to 28, with the overall score reflecting a continuum from very dissatisfied to very satisfied. Higher scores will indicate greater patient satisfaction.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}, {'measure': 'Clinician satisfaction with analgosedation regimen', 'timeFrame': 'Immediately after the procedure', 'description': 'Clinician satisfaction with the analgosedation regimen will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores will reflect a better outcome.\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'During and immediately after the procedure', 'description': 'Incidence of the following adverse events will be recorded: hypoxia, hypotension, treatment-requiring bradycardia, nausea, vomiting, hallucinations, and the need for reversal agents (antidote medication). Each event will be reported as a dichotomous outcome (present or absent).\n\nPatients will be assessed clinically for alertness and readiness to respond before being asked the outcome questions. Only once they are awake and able to provide informed responses will the assessments be performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency Department', 'Procedural sedation and analgesia'], 'conditions': ['Pain, Procedural', 'Analgesia', 'Extremity Injury', 'Patient Satisfaction', 'Satisfaction, Personal', 'Satisfaction', 'Upper Extremity Injury', 'Lower Extremity Fracture', 'Upper Extremity Fracture', 'Extremity Injuries Lower']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.\n\nThe main questions it aims to answer are:\n\n* Which sedation and analgesia methods provide the best patient satisfaction and pain relief?\n* How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?\n\nThe investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation/analgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.\n\nParticipants will:\n\nBe adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.\n\nReceive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.\n\nReport their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.', 'detailedDescription': 'Please refer to the full protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients with upper and lower extremity injuries that require painful stabilizing treatment in the emergency department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18.\n2. Patients with the following injuries are eligible:\n\n 1. Reduction treatment of shoulder dislocation\n 2. Reduction treatment of elbow dislocation\n 3. Reduction treatment of distal radius fractures, application of cast\n 4. Reduction treatment of finger fractures/dislocation\n 5. Casting treatment of upper extremity fractures\n\n * Proximal humerus fracture, application of fixed sling\n * Humeral shaft fracture, application of Sarmiento brace\n * Supracondylar fracture, application of angled cast\n 6. Reduction treatment of hip dislocation\n 7. Reduction treatment of patella dislocation\n 8. Reduction of tibial shaft fracture, application of cast\n 9. Reduction treatment of ankle fractures including distal tibia fracture\n 10. Reduction treatment for toe fractures/dislocation\n 11. Casting treatment of lower extremity fractures\n\n * Distal femur fracture, application of cast/traction\n * Proximal tibia fracture, application of cast or hinged brace\n * Ankle fracture, application of walker\n\nExclusion Criteria:\n\n1. Unable to give informed consent (e.g. unconscious, psychotic or dementia)\n2. Unwilling to participate in the study\n3. Prior inclusion in the study\n4. Already included in another clinical study at the same day/hospital visit\n5. Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07314450', 'acronym': 'PAINEX', 'briefTitle': 'Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Region Zealand'}, 'officialTitle': 'Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department', 'orgStudyIdInfo': {'id': 'p-2025-19278'}, 'secondaryIdInfos': [{'id': 'S-20252000-95', 'type': 'OTHER', 'domain': 'The Committees on Health Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extremity injuries', 'description': 'Each department will collect data on the treatment patients with the upper and lower extremity injuries receive during reduction or stabilizing treatment (procedural sedation and/or analgesia, or no treatment).', 'interventionNames': ['Drug: Usual Care']}], 'interventions': [{'name': 'Usual Care', 'type': 'DRUG', 'description': 'No intervention: Patients will receive usual care', 'armGroupLabels': ['Extremity injuries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Holbæk', 'state': 'Region Sjælland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anders Krusenstjerna-Hafstrøm, MD', 'role': 'CONTACT', 'email': 'Andh@regionsjaelland.dk'}, {'name': 'Martin Schou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anders Krusenstjerna-Hafstrøm, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Emergency Department, Holbæk Hospital', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '4600', 'city': 'Køge', 'state': 'Region Sjælland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Marie-Laure Bouchy Jacobsson', 'role': 'CONTACT', 'email': 'majaco@regionsjaelland.dk'}, {'name': 'Marie-Laure Bouchy Jacobsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emergency Department, Zealand University Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '5000', 'city': 'Odense', 'state': 'Region Syddanmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mikkel Brabrand, Professor', 'role': 'CONTACT', 'email': 'mikkel.brabrand@rsyd.dk'}], 'facility': 'Emergency Department, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Sophie Sværke, MD', 'role': 'CONTACT', 'email': 'Ibes@regionsjaelland.dk', 'phone': '31368854'}, {'name': 'Ole Mathiesen, Professor', 'role': 'CONTACT', 'email': 'Omat@regionsjaelland.dk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Zealand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Holbaek Sygehus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sophie Sværke', 'investigatorAffiliation': 'Region Zealand'}}}}