NCT06051227 Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
| NCT ID | NCT06051227 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Acute Pain Due to Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 608 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 608 participants in total. It began in 2024-01-11 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * (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
Contact & Investigator
Markus W Hollmann, Prof. dr. dr.
PRINCIPAL INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Frequently Asked Questions
Who can join the NCT06051227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Pain Due to Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06051227 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 608 participants.
Is NCT06051227 currently recruiting?
Yes, NCT06051227 is actively recruiting participants. Contact the research team at forepain@amsterdamumc.nl for enrollment information.
Where is the NCT06051227 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06051227 clinical trial?
NCT06051227 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Markus W Hollmann, Prof. dr. dr. at Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 608 participants.