Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma

NCT06514469 | Recruiting

• 1 other identifier: Sufentanil02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Injury Traumatic; Pain, Acute

Keywords

sufentanil; acute trauma; pain; paramedic; competence; prehospital

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 vomiting

  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 - NRS (numeric rating scale).

  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).

  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 - 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.

Secondary Outcomes (10)

• 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.

Drug: Sufentanil intravenous administration followed consultation of remote physician

Competency

Patient who were administered sufentanil in acute trauma by paramedics based on their competencies.

Drug: Sufentanil intravenous administration based on paramedic competency

Interventions

Sufentanil intravenous administration followed consultation of remote physician DRUG

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

Also known as: Consultation

Consultation

Sufentanil intravenous administration based on paramedic competency DRUG

Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies

Also known as: Competency

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

Prehospital emergency care Adults patient 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:

• 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)

Sponsors & Collaborators

• Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.: lead

Study Sites (1)

Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace

Karlovy Vary, Karlovy Vary Region, 36006, Czechia

RECRUITING

Related Publications (2)

• Renza M, Sykora R, Peran D, Hricova K, Brizgalova N, Bakurova P, Kukacka M. Pilot implementation of the competence of Czech paramedics to administer sufentanil for the treatment of pain in acute trauma without consulting a physician: observational study. BMC Emerg Med. 2022 Apr 9;22(1):63. doi: 10.1186/s12873-022-00622-8.

  PMID: 35397498 RESULT

• 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

MeSH Terms

Conditions

Wounds and Injuries; Acute Pain; Pain

Interventions

Referral and Consultation; Mental Competency

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• Jiří Smetana, MD

  Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace

  STUDY DIRECTOR

Central Study Contacts

Roman Sýkora, PhD

CONTACT

+420602524203; roman.sykora@zzskvk.cz

David Peřan, PhD

CONTACT

+420728315535; david.peran@zzskvk.cz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, physician

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CZ (1)