Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

Sponsor

Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. (Other)

Overall Status

Completed

CT.gov ID

NCT04913402

Collaborator

Charles University, Czech Republic (Other)

158

Enrollment

Location

Actual Duration (Months)

19.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury Pain	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.

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

158 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 14, 2020

Actual Primary Completion Date :

Mar 23, 2021

Actual Study Completion Date :

May 15, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Consultation

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.

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

Competency

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.

Administration of sufentanil to patients with acute injury by paramedics with competency to administer sufentanil without medical doctor consultation.

Outcome Measures

Primary Outcome Measures

The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea [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 bradypnoea [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. [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 bradypnoea. [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. [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 efficacy of pain treatment by the paramedics with competence to sufentanil -administration in acute trauma - numeric rating scale. [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).

Secondary Outcome Measures

Dose of administered sufentanil [After sufentanil administration, up to 60 minutes.]
The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.
Incidence of potentiation of analgesia by other analgesics [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).
Types of drugs used for potentiation of analgesia by sufentanil [After sufentanil administration, up to 60 minutes.]
The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).
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 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).
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.]
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).
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 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).
The influence on peripheral oxygen saturation (SpO2) [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.
Need for oxygenotherapy [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)