Comparing Fentanyl and Esketamine for Traumatic Pain Relief
Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
This study is testing whether using fentanyl or esketamine through the nose can provide the same pain relief as the standard intravenous fentanyl for people with acute traumatic pain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 608 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06051227 on ClinicalTrials.gov |
What this trial studies
The FORE-PAIN trial is a Phase 3 double-blind, multi-arm randomized non-inferiority trial that evaluates the effectiveness and safety of intranasal fentanyl and esketamine compared to intravenous fentanyl for managing acute traumatic pain in a prehospital setting. Participants will receive one of the four treatments: fentanyl intranasal, esketamine intravenous, esketamine intranasal, or fentanyl intravenous. The study aims to determine if the alternative administration routes of fentanyl and esketamine are equally effective and safe as the standard intravenous fentanyl. This trial is conducted in collaboration with Emergency Medical Services personnel in Amsterdam.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced acute pain due to trauma on the same day and require strong analgesia as determined by Emergency Medical Services.
Not a fit: Patients who are unable to understand Dutch or English, or those with severe cardiovascular disease or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective pain management options for trauma patients in emergency settings.
How similar studies have performed: Previous studies have shown promising results with similar approaches in pain management, but this specific comparison of intranasal and intravenous administration of these medications is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Ambulance Amsterdam — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Markus W Hollmann, Prof. dr. dr. — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Robert P Weenink, PhD
- Email: forepain@amsterdamumc.nl
- Phone: +31 205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.