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

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ClinicalTrials.gov Identifier: NCT06051227
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : January 17, 2024
Sponsor:
Collaborators:
Stichting ZiektekostenVerzekering Krijgsmacht
Ambulance Amsterdam
Information provided by (Responsible Party):
Robert Weenink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Pain Due to Trauma Analgesia Fentanyl Esketamine Emergency Medical Services Drug: Fentanyl Citrate Drug: Esketamine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Fentanyl OR Esketamine for Traumatic PAIN (FORE-PAIN) Trial
Actual Study Start Date : January 11, 2024
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fentanyl IV
Opioid analgesic Form: fentanyl solution for injection/infusion Administration: intravenous Initial dose: 1 ug/kg Second dose (if required): 0.6ug/kg
 Drug: Fentanyl Citrate
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Experimental: Fentanyl IN
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
 Drug: Fentanyl Citrate
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Experimental: Esketamine IV
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
 Drug: Esketamine
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Experimental: Esketamine IN
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
 Drug: Esketamine
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051227


Contacts
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Contact: Robert P Weenink, PhD +31 205669111 forepain@amsterdamumc.nl

Locations
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Netherlands
Ambulance Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Midas de Grunt, MD       forepain@amsterdamumc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Stichting ZiektekostenVerzekering Krijgsmacht
Ambulance Amsterdam
Investigators
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Principal Investigator: Markus W Hollmann, Prof. dr. dr. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: Robert Weenink, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT06051227    
Other Study ID Numbers: FP-2023
2022-500176-63-00 ( Other Identifier: EU Clinical Trials Information System )
U1111-1287-7486 ( Other Identifier: ICTRP )
2022-000039-22 ( EudraCT Number )
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: January 17, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Metadata and the final data will be published. Conditions for reuse apply.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Metadata are published before locking of the database. The final data are published at the time of the journal article's publication.
Access Criteria: Conditions for reuse of data are described in the patient information folder. Access to the data can be granted by the Principal Investigator based on these criteria.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Weenink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Analgesics
Ketanest
Administration, intranasal
Administration, intravenous
 Pain management
Drug-Related Side Effects and Adverse Reactions
Anesthetics
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Fentanyl
Esketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antidepressive Agents
Psychotropic Drugs