The Safety of Administration of Sufentanil by Paramedics to Treat Pain in Acute Trauma in The Prehospital Setting: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 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 bradypnoea
研究概览
简要总结
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.
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. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •doctor on site
- •paediatric patient
- •predominantly chronic but not acute pain
- •incomplete documentation
- •other than traumatic reasons for opioid administration (eg. acute coronary syndrome)
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 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).
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 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 efficacy of pain treatment by the paramedics with competence to sufentanil -administration in acute trauma - 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 (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).
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 - vomiting - 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 - 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).
次要结局
- Dose of administered sufentanil(After sufentanil administration, up to 60 minutes.)
- Incidence of potentiation of analgesia by other analgesics(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.)
- The influence on peripheral oxygen saturation (SpO2)(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(Before sufentanil administration and at the time of the handover in hospital, 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 - heart rate (HR)(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.)
研究者
Roman Sýkora, MD, Ph.D.
Research coordinator
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.