Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
NCT ID: NCT06514469
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-07-01
2025-03-31
Brief Summary
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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.
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Detailed Description
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This study will assess 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.
This study will complement the recently published data of the previous study, which, however, took place during the outbreak of COVID-19 and this lockdown situation could have distorted the frequency and nature of the observed cases.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Consultation
Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor.
Sufentanil intravenous administration followed consultation of remote physician
Intravenous 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 based on their competencies.
Sufentanil intravenous administration based on paramedic competency
Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies
Interventions
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Sufentanil intravenous administration followed consultation of remote physician
Intravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.
Sufentanil intravenous administration based on paramedic competency
Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
OTHER
Responsible Party
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Roman Sýkora, MD, Ph.D.
Researcher, physician
Principal Investigators
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Jiří Smetana, MD
Role: STUDY_DIRECTOR
Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
Locations
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Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
Karlovy Vary, Karlovy Vary Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Sufentanil02
Identifier Type: -
Identifier Source: org_study_id
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