Actively Recruiting

Age: 18Years +
All Genders
ID06514469

Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study

Led by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. · Updated on 2024-07-23

300

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of paramedics administering sufentanil intravenously to adults with acute trauma pain, either after consulting an emergency medical doctor by phone or based on their own competency without consultation. This observational study focuses on pain management in trauma patients and aims to build on previous data collected during the COVID-19 pandemic, which may have affected patient cases. The study compares two approaches to sufentanil administration: one where paramedics give the drug after a phone consultation with a medical doctor, and another where paramedics administer it independently based on their training and skills. The study observes patients during prehospital care, assessing outcomes up to 60 minutes after sufentanil is given, including safety and pain relief measures. Participants receive sufentanil from paramedics during emergency response to trauma. Researchers monitor safety by tracking incidents such as apnea, slow breathing, nausea, and vomiting, as well as effectiveness through pain rating scales before administration and at hospital handover. Additional data collected include drug dosage, use of other analgesics, vital signs, oxygen use, and medication needs. The study takes place from July 2024 through March 2025.

CONDITIONS

Brief Title

Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute trauma with severe pain (VAS/NRS > 4)
  • Age over 18 years
  • Conscious patient (GCS = 15; alert in AVPU)
  • Hemodynamically stable patient (systolic blood pressure > 100 mmHg, heart rate > 60/min)
Not Eligible

You will not qualify if you...

  • Emergency medical service doctor present on site
  • Pediatric patients (under 18 years old)
  • Mainly chronic pain instead of acute pain
  • Incomplete medical documentation
  • Opioid administration for non-traumatic reasons (e.g., acute coronary syndrome)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment occur during emergency trauma care.

Monitoring

Duration - Up to 60 minutes after sufentanil administration

Participants are observed during and after sufentanil administration by paramedics in the prehospital setting to assess safety and efficacy of pain treatment.

1 continuous observation period during emergency transport until hospital handover

Trial Site Locations

Total: 1 location

1

Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace

Karlovy Vary, Karlovy Vary Region, Czechia, 36006

Actively Recruiting

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Research Team

R

Roman Sýkora, PhD

D

David Peřan, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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.

Metodej Renza, Roman Sykora, David Peran...

https://pubmed.ncbi.nlm.nih.gov/35397498

Project for the introduction of prehospital analgesia with fentanyl and morphine administered by specially trained paramedics in a rural service area in Germany.

Maximilian Scharonow, Timo Alberding, Wolfgang Oltmanns...

https://pubmed.ncbi.nlm.nih.gov/29158691