Status:
RECRUITING
Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Stichting ZiektekostenVerzekering Krijgsmacht
Ambulance Amsterdam
Conditions:
Acute Pain Due to Trauma
Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the Netherlands. However, it is not known whether they are equally effectiv...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- pain has been caused by a trauma (any trauma mechanism) that occurred on the same day
- Emergency Medical Services personnel determines that administration of a strong opioid or esketamine for analgesia is required
- patient will be transported to a hospital
Exclusion
- (estimated) weight \<40 or \>100 kg
- subject does not understand Dutch or English
- inability to report pain score
- inability to give IN or IV medication
- known severe cardiovascular disease
- pre-eclampsia
- Glasgow Coma Scale score \< 11
- subject is known to have previously declined participation in medical research
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
608 Patients enrolled
Trial Details
Trial ID
NCT06051227
Start Date
January 11 2024
End Date
March 1 2026
Last Update
January 30 2025
Active Locations (1)
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1
Ambulance Amsterdam
Amsterdam, Netherlands