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

Analgesia Clinical Trial

— FORE-PAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051227
• Other study ID #: FP-2023
• Secondary ID: 2022-500176-63-0
• Status: Recruiting
• Phase: Phase 3
• Start date: January 11, 2024
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Robert P Weenink, PhD
• Phone: +31 205669111
• Email: forepain[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fentanyl Citrate
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
• Esketamine
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal

Locations

Country	Name	City	State
Netherlands	Ambulance Amsterdam	Amsterdam

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Ambulance Amsterdam, Stichting ZiektekostenVerzekering Krijgsmacht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score as measured with Numeric Rating Scale (NRS)	NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'	10 minutes after first drug administration
Secondary	Change in pain score as measured with NRS	NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'	20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)
Secondary	Relative change in pain score as measured with NRS	NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'no pain' and 10 means 'worst pain imaginable'	10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)
Secondary	Number of subjects requiring a second dose of study medication	If the patient requires additional analgesia, study medication can be repeated once	10 and 20 minutes after first drug administration
Secondary	Patient satisfaction with pre-hospital analgesia	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'	Time of arrival at the hospital (expected within 30 minutes after first drug administration)
Secondary	Number of patients experiencing adverse events	Including side effects	Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)
Secondary	Number of patients requiring unblinding	E.g. because of treatment failure or side effects	Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)