Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
608 participants
Jan 11, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- (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
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Interventions
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06051227