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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consultation | Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor. |
| |
| Competency | Patient who were administered sufentanil in acute trauma by paramedics based on their competencies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Prehospital emergency care Adults patient Acute trauma with severe pain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roman Sýkora, PhD | Contact | +420602524203 | roman.sykora@zzskvk.cz | |
| David Peřan, PhD | Contact | +420728315535 | david.peran@zzskvk.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jiří Smetana, MD | Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace | Recruiting | Karlovy Vary | Karlovy Vary Region | 36006 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35397498 | Result | 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. | |
| 29158691 |
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Data will be available upon request.
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|
| Sufentanil intravenous administration based on paramedic competency | Drug | Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies |
|
|
| 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. |
| 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. |
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. |
| 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. |
| 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. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D059787 | Acute Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D016743 | Mental Competency |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
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