Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Consultation
Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor.
干预措施: Sufentanil intravenous administration followed consultation of remote physician (Drug)
Competency
Patient who were administered sufentanil in acute trauma by paramedics based on their competencies.
干预措施: Sufentanil intravenous administration based on paramedic competency (Drug)
结局指标
主要结局
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of nausea.
时间窗: 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).
The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - NRS (numeric rating scale).
时间窗: 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).
The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - visual analogue scale.
时间窗: 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).
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea
时间窗: 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).
The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of vomiting
时间窗: 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).
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of bradypnoea
时间窗: 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).
次要结局
- Incidence of potentiation of analgesia by other analgesics(After sufentanil administration, up to 60 minutes.)
- Types of drugs used for potentiation of analgesia by sufentanil(After sufentanil administration, up to 60 minutes.)
- The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure(Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.)
- Dose of administered sufentanil(After sufentanil administration, up to 60 minutes)
- The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure(Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.)
- Need for oxygenotherapy(After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.)
- The influence on haemodynamic parameters - heart rate (HR)(Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.)
- The influence on peripheral oxygen saturation (SpO2)(Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.)
- Atropine usage(After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.)
- Antiemetics usage(After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.)
研究者
Roman Sýkora, MD, Ph.D.
Researcher, physician
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.