RecruitingPhase 3NCT06051227

Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

608 participants

Start Date

Jan 11, 2024

Study Type

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

Min Age: 18 Years

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

DRUGFentanyl Citrate

Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal

DRUGEsketamine

Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal


Locations(1)

Ambulance Amsterdam

Amsterdam, Netherlands

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NCT06051227


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