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

Sponsor

Midas de Grunt (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06051227

Collaborator

Stichting Ziektekosten Verzekering Krijgsmacht (Other), Ambulance Amsterdam (Other)

608

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	Drug: Fentanyl Citrate Drug: Esketamine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

608 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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

Primary Outcome Measures

Change in NRS score [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

Change in NRS score [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'
Relative change in NRS score [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'
Number of subjects requiring a second dose of study medication [10 and 20 minutes after first drug administration]
If the patient requires additional analgesia, study medication can be repeated once
Patient satisfaction with pre-hospital analgesia [Time of arrival at the hospital (expected within 30 minutes after first drug administration)]
NRS score is used to measure satisfaction. NRS is an 11 point Likert scale ranging from 0 to 10, where 0 means 'extremely unsatisfactory' and 10 means 'extremely satisfactory'
Number of patients experiencing adverse events [Up to time of arrival at the hospital (expected within 30 minutes after first drug administration)]
Including side effects
Number of patients requiring unblinding [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age ≥ 18 years
pain has been caused by a trauma (any trauma mechanism) that occurred on the same day
PP determines that administration of a strong opioid or esketamine for analgesia is required
patient will be transported to a hospital