Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Trauma Injury, Pain

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consultation<br>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.<br>* Administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.<br>|
| Competency<br>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.<br>* Administration of sufentanil to patients with acute injury by paramedics with competency to administer sufentanil without medical doctor consultation.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sufentanil, Paramedic, Acute trauma injury, Prehospital emergency care