MedTrace Logo

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

NCT06051227 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

  • Acute Pain Due to Trauma
  • Analgesia
  • Fentanyl
  • Esketamine
  • Emergency Medical Services

Interventions

DRUG

Fentanyl Citrate

Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal

DRUG

Esketamine

Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal

Sponsors & Collaborators

  • Stichting ZiektekostenVerzekering Krijgsmacht

    collaborator UNKNOWN

  • Ambulance Amsterdam

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Markus W Hollmann, Prof. dr. dr. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051227 on ClinicalTrials.gov