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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
First received
Last updated
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
Health authority
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

Study Design


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)
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