Two strong painkillers go Head-to-Head in the ambulance
NCT ID NCT06051227
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Paramedics in the Netherlands often treat severe pain after trauma with either fentanyl or esketamine, but no one knows if one works as well as the other or if a nasal spray works as well as an IV. The FORE-PAIN trial randomly assigns adults with acute traumatic pain to one of four groups: fentanyl IV, fentanyl nasal, esketamine IV, or esketamine nasal. Researchers measure pain scores before and after treatment to see if the alternatives are as effective and safe as the standard IV fentanyl.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fentanyl and esketamine, two strong pain medicines given by IV or nasal spray
- What this could lead to
- If the trial shows they work equally well, paramedics could choose the easiest and fastest option for each patient, including a nasal spray when starting an IV is hard.
- What could go wrong
- This is a single trial in one country, so the results may not apply everywhere. Both drugs can cause sedation and breathing problems, and the trial is designed to check that these risks are similar across the groups.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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235 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
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Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ambulance Amsterdam
Amsterdam, Netherlands
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