Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

May 31, 2021 updated by: Roman Sýkora, MD, Ph.D., Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Karlovarský Kraj
      • Karlovy Vary, Karlovarský Kraj, Czechia, 360 06
        • Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 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.
Administration of sufentanil to patients with acute injury by paramedics with competency to administer sufentanil without medical doctor consultation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The safety of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - incidence of apnea
Time Frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
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
Time Frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
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.
Time Frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
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.
Time Frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
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.
Time Frame: Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.
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.
Time Frame: Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose of administered sufentanil
Time Frame: After sufentanil administration, up to 60 minutes.
The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.
After sufentanil administration, up to 60 minutes.
Incidence of potentiation of analgesia by other analgesics
Time Frame: After sufentanil administration, up to 60 minutes.
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.
Types of drugs used for potentiation of analgesia by sufentanil
Time Frame: After sufentanil administration, up to 60 minutes.
The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).
After sufentanil administration, up to 60 minutes.
The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure
Time Frame: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
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.
The influence on haemodynamic parameters - non invasive blood pressure (BP) - diastolic blood pressure
Time Frame: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
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.
The influence on haemodynamic parameters - heart rate (HR)
Time Frame: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
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.
The influence on peripheral oxygen saturation (SpO2)
Time Frame: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
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.
Need for oxygenotherapy
Time Frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charles University, Czech Republic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roman SYKORA, PhD, Emergency Medical Service of Karlovy Vary Region, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sufentanil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Upon reasonable request disposable by researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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