Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913402
• Other study ID #: Sufentanil
• Status: Completed
• Start date: September 14, 2020
• Est. completion date: May 15, 2021

Study information

• Verified date: May 2021
• Source: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 15, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Trauma Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Czechia	Zdravotnická záchranná služba Karlovarského kraje, p.o.	Karlovy Vary	Karlovarský Kraj

Sponsors (2)

Lead Sponsor	Collaborator
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.	Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Gnirke A, Beckers SK, Gort S, Sommer A, Schröder H, Rossaint R, Felzen M. [Analgesia in the emergency medical service: comparison between tele-emergency physician and call back procedure with respect to application safety, effectiveness and tolerance]. Anaesthesist. 2019 Oct;68(10):665-675. doi: 10.1007/s00101-019-00661-0. Epub 2019 Sep 5. German. — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   website of Emergency Medical Service of Karlovy Vary Region