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

Study acronym: FORE-PAIN
StatusTerminated
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: slow recruitment. Final enrollment: 235 participants (planned 608) · Primary completion date changed from estimate of Mar 2026 to Aug 6, 2026 · Eligibility criteria expanded, about 10 words · 3 more Show 6 more changesShow less
    • Final enrollment: 235 participants (planned 608)
    • Primary completion date changed from estimate of Mar 2026 to Aug 6, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Mar 2025 to Mar 2026v6
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 1, 2024 to Jan 11, 2024v5 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2024 to Jan 11, 2024
  4. Collaborators revised (2)v4 See this version in full on ClinicalTrials.gov ↗
  5. Lead sponsor: Midas de Grunt to Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Primary endpoint revised · Start date: Dec 15, 2023 to Jan 1, 2024 · Secondary endpoints revised (6) · 1 morev3 Show 4 more changesShow less
    • Primary endpoint revised
    • Start date: Dec 15, 2023 to Jan 1, 2024
    • Secondary endpoints revised (6)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Start date: Oct 2023 to Dec 15, 2023v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06051227
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Stichting ZiektekostenVerzekering Krijgsmacht, Ambulance Amsterdam
Conditions Acute Pain Due to Trauma, Analgesia, Fentanyl, Esketamine, Emergency Medical Services
Enrollment 235 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov