Paramedics administering sufentanil for acute trauma pain relief
Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma in Prehospital Setting: Observational Study
This study tests if paramedics can safely give a pain relief medication called sufentanil to adults with acute trauma pain on their own, without needing to consult a doctor first.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O. Academic / other |
| Locations | 1 site (Karlovy Vary, Karlovy Vary Region) |
| Trial ID | NCT06514469 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of paramedics administering sufentanil intravenously to adult patients experiencing acute trauma pain without the presence or consultation of an emergency medical doctor. It aims to assess the competence of paramedics in providing timely pain relief in emergency situations. The study will compare outcomes between sufentanil administration with prior medical consultation and administration based solely on paramedic competency. This research seeks to address gaps in emergency pain management protocols, particularly in scenarios where medical doctors are not immediately available.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are conscious, hemodynamically stable, and experiencing severe pain from acute trauma.
Not a fit: Patients who are pediatric, have chronic pain, or are experiencing pain for non-traumatic reasons will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management in acute trauma situations by allowing paramedics to administer effective analgesics independently.
How similar studies have performed: Previous studies have indicated the potential for paramedics to safely administer analgesics, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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)
Where this trial is running
Karlovy Vary, Karlovy Vary Region
- Zdravotnická záchranná služba Karlovarského kraje, příspěvková organizace — Karlovy Vary, Karlovy Vary Region, Czechia (Recruiting)
Study contacts
- Study coordinator: Roman Sýkora, PhD
- Email: roman.sykora@zzskvk.cz
- Phone: +420602524203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.