Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 10:26 AM
Study NCT ID:
NCT06514469
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
Sponsor:
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Organization:
Study Overview
Official Title:
Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: