Clinical trial NCT06514469: Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
Official title: Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Injury Traumatic
Pain, Acute
Keywords: sufentanil
acute trauma
pain
paramedic
competence
prehospital
Lead sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prehospital emergency care Adults patient Acute trauma with severe pain.

Brief 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.

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.

This study will assess 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.

This 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.

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:

* EMS doctor on site
* paediatric patient (less than 18 years)
* 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 vomiting
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 - NRS (numeric rating 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 - visual analogue 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.
measure: Antiemetics usage
timeFrame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
measure: Atropine usage
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, příspěvková organizace
state: Karlovy Vary Region
Study officials:
affiliation: Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
name: Jiří Smetana, MD
role: STUDY_DIRECTOR
References:
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.
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.