Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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-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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
(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
Trial design
Design model
Parallel
Treatments tested in this trial
Fentanyl Citrate
DrugSubjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Esketamine
DrugSubjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Treatment groups
608 Participants
are divided into 4 treatment groupsGroup A: Fentanyl IVActive comparator 1 intervention
Group B: Fentanyl INExperimental treatment 1 intervention
Group C: Esketamine IVExperimental treatment 1 intervention
Group D: Esketamine INExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain score as measured with Numeric Rating Scale (NRS)
NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
Time frame
10 minutes after first drug administrationSecondary outcomes
1
Change in pain score as measured with NRS
NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
Time frame
20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)2
Relative change in pain score as measured with NRS
NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
Time frame
10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)3
Number of subjects requiring a second dose of study medication
If the patient requires additional analgesia, study medication can be repeated once
Time frame
10 and 20 minutes after first drug administration4
Patient satisfaction with pre-hospital analgesia
Patient satisfaction is measured using an 11 point Likert scale ranging from 0 to 10, where 0 means 'extremely unsatisfactory' and 10 means 'extremely satisfactory'
Time frame
Time of arrival at the hospital (expected within 30 minutes after first drug administration)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Stichting ZiektekostenVerzekering Krijgsmacht
Collaborator
Ambulance Amsterdam
Collaborator
Source ClinicalTrials.gov