Injury TraumaticNCT06514469
Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma
An observational study of Injury Traumatic and Pain, Acute, run by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury Traumatic, Pain, Acute
- What is being tested?
- Sufentanil intravenous administration followed consultation of remote physician and Sufentanil intravenous administration based on paramedic competency
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prehospital emergency care Adults patient Acute trauma with severe pain.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
Karlovy Vary, Karlovy Vary Region, 36006
Roman Sýkora, PhD, +420602524203, roman.sykora@zzskvk.cz
David Peřan, PhD, +420728315535, david.peran@zzskvk.cz
About this study
Official title: Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study
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.
Read the 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.
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
- Injury Traumatic, Pain, Acute
- Being tested
- Sufentanil intravenous administration followed consultation of remote physician, Sufentanil intravenous administration based on paramedic competency
- Keywords
- sufentanil, acute trauma, pain, paramedic, competence, prehospital
- Medical subject headings
- Wounds and Injuries, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil intravenous administration followed consultation of remote physicianDrug
Also called Consultation
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 competencyDrug
Also called Competency
Intravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies
| Study group | Role | What they receive |
|---|---|---|
| Consultation | Patient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor. Receives: Drug: Sufentanil intravenous administration followed consultation of remote physician | |
| Competency | Patient who were administered sufentanil in acute trauma by paramedics based on their competencies. Receives: Drug: Sufentanil intravenous administration based on paramedic competency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Before sufentanil administration and at the handover of the patient to the hospital, up to 60 minutes.
Secondary outcomes (10)
Dose of administered sufentanil
The average dose of administered sufentanil per each case (in micrograms) is reported in both groups.
Measured: After sufentanil administration, up to 60 minutes
Incidence of potentiation of analgesia by other analgesics
Number of cases of potentiation of analgesia by use of additional analgesics and is reported and compared in both groups (pertcentage).
Measured: After sufentanil administration, up to 60 minutes.
Types of drugs used for potentiation of analgesia by sufentanil
The type and generic name of additional analgesics and is reported and compared in both groups (pertcentage).
Measured: After sufentanil administration, up to 60 minutes.
The influence on haemodynamic parameters - non invasive blood pressure (BP) -systolic blood pressure
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).
Measured: 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
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).
Measured: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
The influence on haemodynamic parameters - heart rate (HR)
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).
Measured: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
The influence on peripheral oxygen saturation (SpO2)
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.
Measured: Before sufentanil administration and at the time of the handover in hospital, up to 60 minutes.
Need for oxygenotherapy
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).
Measured: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Antiemetics usage
Antiemetic drugs used after sufentanil administration to treat nausea or vomiting (percentage).
Measured: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Atropine usage
Atropin usage due to bradycardia after sufentanil administration (percentage)
Measured: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Injury TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Sýkora, MD, Ph.D., Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
- Investigators
- Jiří Smetana, MD, Study director, Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514469
- Sponsor's protocol ID
- Sufentanil02
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available upon request.
Publications
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.
PubMed 35397498Scharonow 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.
PubMed 29158691
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study
- ClinicalTrials.gov ID
- NCT06514469
- Acronym / sponsor ID
- Sufentanil02
- Conditions
- Injury Traumatic, Pain, Acute
- Keywords
- sufentanil, acute trauma, pain, paramedic, competence, prehospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.University, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consultation | – | Drug: Sufentanil intravenous administration followed consultation of remote physicianPatient who were administered sufentanil in acute trauma by paramedics after phone call consultation with medical doctor. |
| Competency | – | Drug: Sufentanil intravenous administration based on paramedic competencyPatient who were administered sufentanil in acute trauma by paramedics based on their competencies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prehospital emergency care Adults patient Acute trauma with severe pain.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil intravenous administration followed consultation of remote physicianAlso: ConsultationIntravenous administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor. | Drug | Consultation |
| Sufentanil intravenous administration based on paramedic competencyAlso: CompetencyIntravenous administration of sufentanil to patients with acute injury by paramedics based on their competencies | Drug | Competency |
Primary outcome
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).
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).
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).
The safety of pain treatment by the paramedics with competence to sufentanil administration in acute trauma - incidence of vomiting
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).
The efficacy of pain treatment by the paramedics with competence to sufentanil - administration in acute trauma - NRS (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 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).
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).
10 secondary outcomes
Dose of administered sufentanil
Time frame: After sufentanil administration, up to 60 minutes
Incidence of potentiation of analgesia by other analgesics
Time frame: 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 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 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 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 influence on peripheral oxygen saturation (SpO2)
Time frame: 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.
Antiemetics usage
Time frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Atropine usage
Time frame: After sufentanil administration up to the handover of the patient to the hospital, up to 60 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Results publication: PubMed 35397498Renza 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.
- Results publication: PubMed 29158691Scharonow 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.
- Individual participant dataSharing planned: Undecided. Data will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiří Smetana, MD study director
Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injury Traumatic and Pain, Acute, run by Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roman Sýkora, PhD (+420602524203, roman.sykora@zzskvk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.