Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

Completed

• Conditions: Trauma Injury; Pain

• Registration Number: NCT04913402
• Lead Sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

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.

Study Timeline

• Study Start: 2020-09-14
• Primary Completion: 2021-03-23
• Status Verified: 2021-05
• Study Completion: 2021-05-15
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-31
• Last Update Submitted: 2021-05-31
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of bradypnoea	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.	Measurement of incidence of adverse effects of sufentanil administration in both study groups - bradypnoea - is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea.	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.	Measurement of incidence of adverse effects of sufentanil administration in both study groups - nausea - is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.	Measurement of incidence of adverse effects of sufentanil administration in both study groups - apnea - during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).
The efficacy of pain treatment by the paramedics with competence to sufentanil -administration in acute trauma - numeric rating scale.	Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.	The ten point Numeric rating scale (NRS) is used to measure the efficacy of pain treatment. The difference of NRS before administration of sufentanil and at the handover at the emergency department is calculated and compared in both groups (in points).
The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of bradypnoea.	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.	Measurement of incidence of adverse effects of sufentanil administration in both study groups - vomiting - is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).
The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - visual analogue scale.	Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.	The ten point Visual analogue scale is used to measure the efficacy of pain treatment. The difference of VAS before administration of sufentanil and at the handover at the emergency department is calculated and compared in both groups (in points).

Secondary Outcome Measures

Name	Time	Method
Dose of administered sufentanil	After sufentanil administration, up to 60 minutes.	The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.
Incidence of potentiation of analgesia by other analgesics	After sufentanil administration, up to 60 minutes.	Number of cases of potentiation of analgesia by use of additional analgesics and is reported and compared in both groups (pertcentage).
The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.	The difference of systolic blood pressure before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. Systolic blood pressure is measured in milimeters of hydrargyrum (mmHg).
The influence on peripheral oxygen saturation (SpO2)	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.	The difference of SpO2 before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. SpO2 is measured as percentage.
The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.	The difference of diastolic blood pressure before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. Diastolic blood pressure is measured in milimeters of hydrargyrum (mmHg).
Types of drugs used for potentiation of analgesia by sufentanil	After sufentanil administration, up to 60 minutes.	The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).
The influence on haemodynamic parameters - heart rate (HR)	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.	The difference of heart rate before the administration of sufentanil and at the handover at the emergency department is measured, calculated and compared in both groups. Heart rate is measured as monitored or palpated beats per minute (bpm).
Need for oxygenotherapy	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.	Measurement of incidence of need for oxygenotherapy is measured during the period from sufentanil administration (baseline) up to handover of the patient to the hospital (percentage).

Trial Locations

Locations (1)

Zdravotnická záchranná služba Karlovarského kraje, p.o.; 🇨🇿 Karlovy Vary, Karlovarský Kraj, Czechia