Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 10:26 AM
Study NCT ID:
NCT06514469
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D016743', 'term': 'Mental Competency'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D007603', 'term': 'Jurisprudence'}, {'id': 'D012926', 'term': 'Social Control, Formal'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Measurement of incidence of adverse effects of sufentanil administration in both study groups - apnea - during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).'}, {'measure': 'The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of bradypnoea', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Measurement of incidence of adverse effects of sufentanil administration in both study groups - bradypnoea - is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).'}, {'measure': 'The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea.', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Measurement of incidence of adverse effects of sufentanil administration in both study groups - nausea - is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).'}, {'measure': 'The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of vomiting', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Measurement of incidence of adverse effects of sufentanil administration in both study groups - vomiting - is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).'}, {'measure': 'The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - NRS (numeric rating scale).', 'timeFrame': 'Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.', 'description': 'The ten point Numeric rating scale is used to measure the efficacy of pain treatment. The difference of VAS before administration of sufentanil and at the handover at the emergency department is calculated and compared in both groups (in points).'}, {'measure': 'The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - visual analogue scale.', 'timeFrame': 'Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.', 'description': 'The ten point Visual analogue scale is used to measure the efficacy of pain treatment. The difference of VAS before administration of sufentanil and at the handover at the emergency department is calculated and compared in both groups (in points).'}], 'secondaryOutcomes': [{'measure': 'Dose of administered sufentanil', 'timeFrame': 'After sufentanil administration, up to 60 minutes', 'description': 'The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.'}, {'measure': 'Incidence of potentiation of analgesia by other analgesics', 'timeFrame': 'After sufentanil administration, up to 60 minutes.', 'description': 'Number of cases of potentiation of analgesia by use of additional analgesics and is reported and compared in both groups (pertcentage).'}, {'measure': 'Types of drugs used for potentiation of analgesia by sufentanil', 'timeFrame': 'After sufentanil administration, up to 60 minutes.', 'description': 'The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).'}, {'measure': 'The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure', 'timeFrame': 'Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.', 'description': 'The difference of systolic blood pressure before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. Systolic blood pressure is measured in milimeters of hydrargyrum (mmHg).'}, {'measure': 'The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure', 'timeFrame': 'Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.', 'description': 'The difference of diastolic blood pressure before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. Diastolic blood pressure is measured in milimeters of hydrargyrum (mmHg).'}, {'measure': 'The influence on haemodynamic parameters - heart rate (HR)', 'timeFrame': 'Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.', 'description': 'The difference of heart rate before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. Heart rate is measured as monitored or palpated beats per minute (bpm).'}, {'measure': 'The influence on peripheral oxygen saturation (SpO2)', 'timeFrame': 'Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.', 'description': 'The difference of SpO2 before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. SpO2 is measured as percentage.'}, {'measure': 'Need for oxygenotherapy', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Measurement of incidence of need for oxygenotherapy is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).'}, {'measure': 'Antiemetics usage', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Antiemetic drugs used after sufentanil administration to treat nausea or vomiting (percentage).'}, {'measure': 'Atropine usage', 'timeFrame': 'After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.', 'description': 'Atropin usage due to bradycardia after sufentanil administration (percentage)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sufentanil', 'acute trauma', 'pain', 'paramedic', 'competence', 'prehospital'], 'conditions': ['Injury Traumatic', 'Pain, Acute']}, 'referencesModule': {'references': [{'pmid': '35397498', 'type': 'RESULT', 'citation': 'Renza M, Sykora R, Peran D, Hricova K, Brizgalova N, Bakurova P, Kukacka M. Pilot implementation of the competence of Czech paramedics to administer sufentanil for the treatment of pain in acute trauma without consulting a physician: observational study. BMC Emerg Med. 2022 Apr 9;22(1):63. doi: 10.1186/s12873-022-00622-8.'}, {'pmid': '29158691', 'type': 'RESULT', 'citation': 'Scharonow M, Alberding T, Oltmanns W, Weilbach C. Project for the introduction of prehospital analgesia with fentanyl and morphine administered by specially trained paramedics in a rural service area in Germany. J Pain Res. 2017 Nov 6;10:2595-2599. doi: 10.2147/JPR.S151077. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The safety and efficacy of competence of paramedics to administer sufentanil intravenously in adult acute trauma patients without presence or without phone-call consult with an emergency medical doctor will be assessed in this observational study.\n\nCondition or disease: pain in trauma or injury. Intervention/treatment: sufentanil administered by paramedics after the phone call consultation of medical doctor versus sufentanil administered by paramedics based on their competency, without consultation of medical doctor.', 'detailedDescription': 'The administration and indication of an opioid analgesics is carried by a medical doctor in most European emergency services. However, trips to majority of less serious traumas are realized by ambulances with paramedic crews without a medical doctor present on site.\n\nThis study will assess the new competence of paramedics to administer opioid analgesics without presence or phone-call consult with an emergency medical doctor.\n\nThis study will address the safety and efficacy of sufentanil administered by the paramedics in the field to patients with acute trauma without any consultation with medical doctors.\n\nThis study will complement the recently published data of the previous study, which, however, took place during the outbreak of COVID-19 and this lockdown situation could have distorted the frequency and nature of the observed cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prehospital emergency care Adults patient Acute trauma with severe pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute trauma with severe pain (VAS/NRS \\> 4)\n* age \\> 18 years\n* conscious patient (GCS = 15; alert in AVPU)\n* haemodynamically stable patient (\\> 100mmHg of systolic blood pressure, \\> 60/min of heart rate)\n\nExclusion Criteria:\n\n* EMS doctor on site\n* paediatric patient (less than 18 years)\n* predominantly chronic but not acute pain\n* incomplete documentation\n* other than traumatic reasons for opioid administration (eg. acute coronary syndrome)'}, 'identificationModule': {'nctId': 'NCT06514469', 'briefTitle': 'Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.'}, 'officialTitle': 'Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study', 'orgStudyIdInfo': {'id': 'Sufentanil02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Consultation', 'description': 'Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor.', 'interventionNames': ['Drug: Sufentanil intravenous administration followed consultation of remote physician']}, {'label': 'Competency', 'description': 'Patient who were administered sufentanil in acute trauma by paramedics based on their competencies.', 'interventionNames': ['Drug: Sufentanil intravenous administration based on paramedic competency']}], 'interventions': [{'name': 'Sufentanil intravenous administration followed consultation of remote physician', 'type': 'DRUG', 'otherNames': ['Consultation'], 'description': 'Intravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.', 'armGroupLabels': ['Consultation']}, {'name': 'Sufentanil intravenous administration based on paramedic competency', 'type': 'DRUG', 'otherNames': ['Competency'], 'description': 'Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies', 'armGroupLabels': ['Competency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36006', 'city': 'Karlovy Vary', 'state': 'Karlovy Vary Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Roman Sýkora, PhD', 'role': 'CONTACT', 'email': 'roman.sykora@zzskvk.cz', 'phone': '+420602524203'}, {'name': 'David Peřan, PhD', 'role': 'CONTACT', 'email': 'david.peran@zzskvk.cz', 'phone': '+420728315535'}], 'facility': 'Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace', 'geoPoint': {'lat': 50.23271, 'lon': 12.87117}}], 'centralContacts': [{'name': 'Roman Sýkora, PhD', 'role': 'CONTACT', 'email': 'roman.sykora@zzskvk.cz', 'phone': '+420602524203'}, {'name': 'David Peřan, PhD', 'role': 'CONTACT', 'email': 'david.peran@zzskvk.cz', 'phone': '+420728315535'}], 'overallOfficials': [{'name': 'Jiří Smetana, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher, physician', 'investigatorFullName': 'Roman Sýkora, MD, Ph.D.', 'investigatorAffiliation': 'Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.'}}}}