Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
acute trauma with severe pain (VAS/NRS > 4)
age > 18 years
conscious patient (GCS = 15; alert in AVPU)
haemodynamically stable patient (> 100mmHg of systolic blood pressure, > 60/min of heart rate)
Disqualifiers
EMS doctor on site
paediatric patient (less than 18 years)
predominantly chronic but not acute pain
incomplete documentation
Trial population
Prehospital emergency care Adults patient Acute trauma with severe pain.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Sufentanil intravenous administration followed consultation of remote physician
DrugIntravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.
Sufentanil intravenous administration based on paramedic competency
DrugIntravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Consultation1 intervention
Group B: Competency1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.2
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).
Time frame
After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.3
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).
Time frame
After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.4
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).
Time frame
After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.Secondary outcomes
1
Dose of administered sufentanil
The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.
Time frame
After sufentanil administration, up to 60 minutes2
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).
Time frame
After sufentanil administration, up to 60 minutes.3
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).
Time frame
After sufentanil administration, up to 60 minutes.4
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).
Time frame
Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.Sponsors and contacts
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Source ClinicalTrials.gov