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New treatment option for Acute Pain Due to Trauma
Official title Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
ClinicalTrials.gov ID: NCT06051227
What this study is testing
What is Fentanyl Citrate?
Fentanyl Citrate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute pain due to trauma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- (estimated) weight \ 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
See the full eligibility 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
- (estimated) weight \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.