Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Recruiting
Phase 3
Interventional Study
Acute Pain Due to Trauma
Analgesia
Fentanyl
Esketamine
Emergency Medical Services
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 608 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Other
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About This Trial
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-bli…
Trial Locations
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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
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Contacts