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NCT Number: NCT06051227

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

Recruiting

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Key information

Conditions

Acute Pain Due to Trauma Agnosia Analgesia Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Emergency Medical Services Esketamine Fentanyl Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ambulance Amsterdam

Amsterdam, Netherlands

Location status: Recruiting

Location contact

Midas de Grunt, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Citrate

Drug

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

Esketamine

Drug

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

Primary outcomes

  1. Change in pain score as measured with Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Change in pain score as measured with NRS

    Time frame: 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'

  2. Relative change in pain score as measured with NRS

    Time frame: 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'

  3. Number of subjects requiring a second dose of study medication

    Time frame: 10 and 20 minutes after first drug administration

    If the patient requires additional analgesia, study medication can be repeated once

  4. Patient satisfaction with pre-hospital analgesia

    Time frame: 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'

  5. Number of patients experiencing adverse events

    Time frame: Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)

    Including side effects

  6. Number of patients requiring unblinding

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Robert P Weenink, PhD

CONTACT

[email protected]

+31 205669111

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Ambulance Amsterdam
  • Stichting ZiektekostenVerzekering Krijgsmacht

Registry information

Acronym: FORE-PAIN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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