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NCT Number: NCT06514469

Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma

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.

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Key information

Conditions

Injury Traumatic Acute Pain Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sufentanil intravenous administration followed consultation of remote physician

Drug

Intravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.

Other names: Consultation

Sufentanil intravenous administration based on paramedic competency

Drug

Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies

Other names: Competency

Primary outcomes

  1. The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea

    Time frame: 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).

  2. The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of bradypnoea

    Time frame: 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).

  3. The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea.

    Time frame: 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).

  4. The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of vomiting

    Time frame: 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).

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

    Time frame: Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.

    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).

  6. The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - visual analogue scale.

    Time frame: 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 outcomes

  1. Dose of administered sufentanil

    Time frame: After sufentanil administration, up to 60 minutes

    The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.

  2. Incidence of potentiation of analgesia by other analgesics

    Time frame: 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).

  3. Types of drugs used for potentiation of analgesia by sufentanil

    Time frame: After sufentanil administration, up to 60 minutes.

    The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).

  4. The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure

    Time frame: 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).

  5. The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure

    Time frame: 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).

  6. The influence on haemodynamic parameters - heart rate (HR)

    Time frame: 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).

  7. The influence on peripheral oxygen saturation (SpO2)

    Time frame: 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.

  8. Need for oxygenotherapy

    Time frame: 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).

  9. Antiemetics usage

    Time frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.

    Antiemetic drugs used after sufentanil administration to treat nausea or vomiting (percentage).

  10. Atropine usage

    Time frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.

    Atropin usage due to bradycardia after sufentanil administration (percentage)

Study contacts

Contact information is provided by the study sponsor or research team.

David Peřan, PhD

CONTACT

[email protected]

+420728315535

Roman Sýkora, PhD

CONTACT

[email protected]

+420602524203

Sponsors and collaborators

Lead sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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