Clinical trial NCT06051227: Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Official title: Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Pain Due to Trauma
Analgesia
Fentanyl
Esketamine
Emergency Medical Services
Keywords: Analgesics
Ketanest
Administration, intranasal
Administration, intravenous
Pain management
Drug-Related Side Effects and Adverse Reactions
Anesthetics
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Stichting ZiektekostenVerzekering Krijgsmacht
name: Ambulance Amsterdam
First posted: 2023-09-22
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Change in pain score as measured with Numeric Rating Scale (NRS)
timeFrame: 10 minutes after first drug administration
Secondary outcomes:
measure: Change in pain score as measured with NRS
timeFrame: 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)
measure: Relative change in pain score as measured with NRS
timeFrame: 10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)
measure: Number of subjects requiring a second dose of study medication
timeFrame: 10 and 20 minutes after first drug administration
measure: Patient satisfaction with pre-hospital analgesia
timeFrame: Time of arrival at the hospital (expected within 30 minutes after first drug administration)
measure: Number of patients experiencing adverse events
timeFrame: Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)
measure: Number of patients requiring unblinding
timeFrame: Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Ambulance Amsterdam
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Markus W Hollmann, Prof. dr. dr.
role: PRINCIPAL_INVESTIGATOR
References: