Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial
- Conditions
- EsketamineEmergency Medical ServicesAnalgesiaAcute Pain Due to TraumaFentanyl
- Interventions
- Registration Number
- NCT06051227
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 608
- 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 <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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fentanyl IN Fentanyl Citrate Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intranasal using nasal atomizer Initial dose: 1.25 ug/kg to a maximum of 100ug Second dose (if required): 1ug/kg to a maximum total dose of 2ug/kg Fentanyl IV Fentanyl Citrate Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intravenous Initial dose: 1 ug/kg Second dose (if required): 0.6ug/kg Esketamine IV Esketamine Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection/infusion Administration: intravenous Initial dose: 0.2mg/kg Second dose (if required): 0.12mg/kg Esketamine IN Esketamine Anesthetic, in lower doses the analgesic effect is dominant Form: esketamine solution for injection/infusion Administration: intranasal using a nasal atomizer Initial dose: 0.625mg/kg to a maximum of 50mg Second dose (if required): 0.5mg/kg to a maximum total dose of 1mg/kg
- Primary Outcome Measures
Name Time Method Change in pain score as measured with Numeric Rating Scale (NRS) 10 minutes after first drug administration NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
- Secondary Outcome Measures
Name Time Method Number of subjects requiring a second dose of study medication 10 and 20 minutes after first drug administration If the patient requires additional analgesia, study medication can be repeated once
Number of patients requiring unblinding Up to time of arrival at the hospital (expected within 30 minutes after first drug administration) E.g. because of treatment failure or side effects
Change in pain score as measured with NRS 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration) NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
Number of patients experiencing adverse events Up to time of arrival at the hospital (expected within 30 minutes after first drug administration) Including side effects
Relative change in pain score as measured with NRS 10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration) NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'
Patient satisfaction with pre-hospital analgesia Time of arrival at the hospital (expected within 30 minutes after first drug administration) 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'
Trial Locations
- Locations (1)
Ambulance Amsterdam
🇳🇱Amsterdam, Netherlands