Actively Recruiting
Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-01-30
608
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
S
Stichting ZiektekostenVerzekering Krijgsmacht
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 effective and safe. It is also not known whether intranasal (IN) administration of fentanyl or esketamine is equally effective and safe as intravenous (IV) administration. The FORE-PAIN trial is a double-blind multi-arm randomized non-inferiority trial comparing Fentanyl IN, esketamine IV and esketamine IN (intervention arms) to fentanyl IV (comparator arm) for prehospital management of traumatic pain. The investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.
CONDITIONS
Official Title
Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pain caused by trauma occurring on the same day
- Emergency Medical Services personnel determine that strong opioid or esketamine analgesia is needed
- Patient will be transported to a hospital
You will not qualify if you...
- Estimated weight less than 40 kg or more than 100 kg
- Does not understand Dutch or English
- Unable to report pain score
- Unable to receive intranasal or intravenous medication
- Known severe cardiovascular disease
- Pre-eclampsia
- Glasgow Coma Scale score less than 11
- Previously declined participation in medical research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ambulance Amsterdam
Amsterdam, Netherlands
Actively Recruiting
Research Team
R
Robert P Weenink, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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