Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

The Safety of Administration of Sufentanil by Paramedics to Treat Pain in Acute Trauma in The Prehospital Setting: Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Trauma Injury
• Intervention / Treatment: Other: Sufentanil administered by paramedics after the phone call consultation of medical doctor.; Other: 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. 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 Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Czechia
  • Karlovarský Kraj
    • Karlovy Vary, Karlovarský Kraj, Czechia, 360 06
      • Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults patient in prehospital emergency care, who suffered 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:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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.	Other: Sufentanil administered by paramedics after the phone call consultation of medical doctor.; Administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.
Competency; Patient who were administered sufentanil in acute trauma by paramedics with competence to administer sufentanil without any consultation with medical doctor.	Other: Sufentanil administered by paramedics based on their competency, without consultation of medical doctor.; Administration of sufentanil to patients with acute injury by paramedics with competency to administer sufentanil without medical doctor consultation.

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 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 - 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 - 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 efficacy of pain treatment by the paramedics with competence to sufentanil -administration in acute trauma - numeric rating scale.	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).	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
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.
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.

Collaborators and Investigators

• Sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
• Collaborators: Charles University, Czech Republic
• Investigators: Principal Investigator: Roman SYKORA, PhD, Emergency Medical Service of Karlovy Vary Region, Czech Republic

Publications and helpful links

General Publications

• Gnirke A, Beckers SK, Gort S, Sommer A, Schroder H, Rossaint R, Felzen M. [Analgesia in the emergency medical service: comparison between tele-emergency physician and call back procedure with respect to application safety, effectiveness and tolerance]. Anaesthesist. 2019 Oct;68(10):665-675. doi: 10.1007/s00101-019-00661-0. Epub 2019 Sep 5. German.
• 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.

Helpful Links

• website of Emergency Medical Service of Karlovy Vary Region

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Sufentanil; Prehospital emergency care; Paramedic; Acute trauma injury
• 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: Sufentanil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Upon reasonable request disposable by researchers.

Drug and device information, study documents

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