Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
NCT Number: NCT06514469
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Injury Traumatic|Pain, Acute
Interventions: DRUG: Sufentanil intravenous administration followed consultation of remote physician|DRUG: Sufentanil intravenous administration based on paramedic competency
Sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-03-31
Locations: Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace, Karlovy Vary, Karlovy Vary Region, 36006, Czechia

Summary:
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.

Condition 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.

Primary Outcome Measures: The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea, 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)., After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.|The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of bradypnoea, 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)., After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.|The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea., 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)., After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.|The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of vomiting, 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)., After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.|The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - NRS (numeric rating scale)., 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)., Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.|The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - visual analogue scale., 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)., Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.
Secondary Outcome Measures: Dose of administered sufentanil, The average dose of administered sufentanil per each case (in micrograms) is reported in both groups., After sufentanil administration, up to 60 minutes|Incidence of potentiation of analgesia by other analgesics, Number of cases of potentiation of analgesia by use of additional analgesics and is reported and compared in both groups (pertcentage)., After sufentanil administration, up to 60 minutes.|Types of drugs used for potentiation of analgesia by sufentanil, The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage)., After sufentanil administration, up to 60 minutes.|The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure, 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)., Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.|The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure, 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)., Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.|The influence on haemodynamic parameters - heart rate (HR), 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)., Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.|The influence on peripheral oxygen saturation (SpO2), 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., Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.|Need for oxygenotherapy, 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)., After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.|Antiemetics usage, Antiemetic drugs used after sufentanil administration to treat nausea or vomiting (percentage)., After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.|Atropine usage, Atropin usage due to bradycardia after sufentanil administration (percentage), After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.