Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

NCT04913402 | Completed

• 1 other identifier: Sufentanil
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury; Pain

Keywords

Sufentanil; Paramedic; Acute trauma injury; Prehospital emergency care

Outcome Measures

Primary Outcomes (6)

• 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 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.

• 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.

• 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 Outcomes (8)

• 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.

• 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) -systolic blood pressure

  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.

Study Arms (2)

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.

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.

Interventions

Sufentanil administered by paramedics after the phone call consultation of medical doctor. OTHER

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

Consultation

Sufentanil administered by paramedics based on their competency, without consultation of medical doctor. OTHER

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

Competency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patient in prehospital emergency care, who suffered acute trauma with severe pain.

You may qualify if:

• 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)

You may not qualify if:

• doctor on site
• paediatric patient
• predominantly chronic but not acute pain
• incomplete documentation
• other than traumatic reasons for opioid administration (eg. acute coronary syndrome)

Sponsors & Collaborators

• Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.: lead
• Charles University, Czech Republic: collaborator

Study Sites (1)

Zdravotnická záchranná služba Karlovarského kraje, p.o.

Karlovy Vary, Karlovarský kraj, 360 06, Czechia

Location

Related Publications (2)

• Gnirke A, Beckers SK, Gort S, Sommer A, Schroder 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.

  PMID: 31489458 BACKGROUND

• 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.

  PMID: 29158691 RESULT

Related Links

• website of Emergency Medical Service of Karlovy Vary Region

MeSH Terms

Conditions

Accidental Injuries; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roman SYKORA, PhD

  Emergency Medical Service of Karlovy Vary Region, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 4, 2021
• Study Start: September 14, 2020
• Primary Completion: March 23, 2021
• Study Completion: May 15, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-05

Locations

CZ (1)