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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Injury Traumatic
• Intervention / Treatment: Drug: Sufentanil intravenous administration followed consultation of remote physician; Drug: Sufentanil intravenous administration based on paramedic competency

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Roman Sýkora, PhD; Phone Number: +420602524203; Email: roman.sykora@zzskvk.cz
• Study Contact Backup: Name: David Peřan, PhD; Phone Number: +420728315535; Email: david.peran@zzskvk.cz

Study Locations

• Czechia
  • Karlovy Vary Region
    • Karlovy Vary, Karlovy Vary Region, Czechia, 36006
      • Recruiting
      • Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
      • Contact: Roman Sýkora, PhD; Phone Number: +420602524203; Email: roman.sykora@zzskvk.cz
      • Contact: David Peřan, PhD; Phone Number: +420728315535; Email: david.peran@zzskvk.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prehospital emergency care Adults patient Acute trauma with severe pain.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consultation; Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor.	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.; Other Names: Consultation
Competency; Patient who were administered sufentanil in acute trauma by paramedics based on their competencies.	Drug: Sufentanil intravenous administration based on paramedic competency; Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies; Other Names: Competency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea	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).	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of bradypnoea	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).	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea.	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).	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - visual analogue scale.	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).	Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.
The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of vomiting	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).	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - NRS (numeric rating scale).	The ten point Numeric rating 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).	Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of potentiation of analgesia by other analgesics	Number of cases of potentiation of analgesia by use of additional analgesics and is reported and compared in both groups (pertcentage).	After sufentanil administration, up to 60 minutes.
Types of drugs used for potentiation of analgesia by sufentanil	The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).	After sufentanil administration, up to 60 minutes.
The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure	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).	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure	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).	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
The influence on haemodynamic parameters - heart rate (HR)	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).	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
The influence on peripheral oxygen saturation (SpO2)	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.	Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
Need for oxygenotherapy	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).	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Dose of administered sufentanil	The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.	After sufentanil administration, up to 60 minutes
Antiemetics usage	Antiemetic drugs used after sufentanil administration to treat nausea or vomiting (percentage).	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Atropine usage	Atropin usage due to bradycardia after sufentanil administration (percentage)	After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.

Collaborators and Investigators

• Sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
• Investigators: Study Director: Jiří Smetana, MD, Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pain; sufentanil; prehospital; acute trauma; competence; paramedic
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil; Dsuvia
• Other Study ID Numbers: Sufentanil02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No