Clinical trial NCT04913402: Sufentanil Used by Paramedics to Treat Pain in Acute Trauma
Official title: The Safety of Administration of Sufentanil by Paramedics to Treat Pain in Acute Trauma in The Prehospital Setting: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Pain
Keywords: Sufentanil
Paramedic
Acute trauma injury
Prehospital emergency care
Lead sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
First posted: 2021-06-04
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patient in prehospital emergency care, who suffered acute trauma with severe pain.

Brief summary: The new competence of paramedics to administer opioid analgesics in acute trauma patients without presence or phone-call consult with an emergency medical doctor will be assessed in this study.

Detailed description: 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. In this study will be assessed the new competence of paramedics to administer opioid analgesics without presence or phone-call consult with an emergency medical doctor.

This 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* doctor on site
* paediatric patient
* predominantly chronic but not acute pain
* incomplete documentation
* other than traumatic reasons for opioid administration (eg. acute coronary syndrome)

Primary outcomes:
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.
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.
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.
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.
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.
measure: The efficacy of pain treatment by the paramedics with competence to sufentanil -administration in acute trauma - numeric rating scale.
timeFrame: Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.
Secondary outcomes:
measure: Dose of administered sufentanil
timeFrame: After sufentanil administration, up to 60 minutes.
measure: Incidence of potentiation of analgesia by other analgesics
timeFrame: After sufentanil administration, up to 60 minutes.
measure: Types of drugs used for potentiation of analgesia by sufentanil
timeFrame: After sufentanil administration, up to 60 minutes.
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.
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.
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.
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.
measure: Need for oxygenotherapy
timeFrame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Other outcomes:
Locations:
city: Karlovy Vary
country: Czechia
facility: Zdravotnická záchranná služba Karlovarského kraje, p.o.
state: Karlovarský Kraj
Study officials:
affiliation: Emergency Medical Service of Karlovy Vary Region, Czech Republic
name: Roman SYKORA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnirke A, Beckers SK, Gort S, Sommer A, Schroder H, Rossaint R, Felzen M. [Analgesia in the emergency medical service: comparison between tele-emergency physician and call back procedure with respect to application safety, effectiveness and tolerance]. Anaesthesist. 2019 Oct;68(10):665-675. doi: 10.1007/s00101-019-00661-0. Epub 2019 Sep 5. German.
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.