Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Enrolling; Phase 3

Conditions: Acute Pain Due to Trauma; Esketamine; Fentanyl; Emergency Medical Services; Analgesia

Treatments: Drug: Esketamine; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06051227

FP-2023

U1111-1287-7486 (Other Identifier)

2022-500176-63-00 (Other Identifier)

2022-000039-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 608 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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608 participants in 4 patient groups

Fentanyl IV

Active Comparator group

Description:

Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intravenous Initial dose: 1 ug/kg Second dose (if required): 0.6ug/kg

Treatment:

Drug: Fentanyl Citrate

Fentanyl IN

Experimental group

Description:

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

Treatment:

Drug: Fentanyl Citrate

Esketamine IV

Experimental group

Description:

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

Treatment:

Drug: Esketamine

Esketamine IN

Experimental group

Description:

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

Treatment:

Drug: Esketamine