NCT06514469

Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma

Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Injury Traumatic
• Pain, Acute

Interventions

Type	Name	Description
DRUG	Sufentanil intravenous administration followed consultation of remote physician	Intravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.
DRUG	Sufentanil intravenous administration based on paramedic competency	Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Czechia