Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Status: Enrolling

Conditions: Injury Traumatic; Pain, Acute

Treatments: Drug: Sufentanil intravenous administration followed consultation of remote physician; Drug: Sufentanil intravenous administration based on paramedic competency

Study type: Observational

Funder types: Other

Identifiers

NCT06514469

Sufentanil02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 2 patient groups

Consultation

Description:

Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor.

Treatment:

Drug: Sufentanil intravenous administration followed consultation of remote physician

Competency

Description:

Patient who were administered sufentanil in acute trauma by paramedics based on their competencies.

Treatment:

Drug: Sufentanil intravenous administration based on paramedic competency