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

Phase 3RecruitingNCT06051227

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)608 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

608

Conditions

Acute Pain Due to Trauma Analgesia Fentanyl Esketamine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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'

Time frame: 10 minutes after first drug administration

Secondary Outcomes

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'

Time frame: 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)

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'

Time frame: 10 and 20 minutes after first drug administration; time of arrival at the hospital (expected within 30 minutes after first drug administration)

Number of subjects requiring a second dose of study medication

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

Time frame: 10 and 20 minutes after first drug administration

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

Number of patients experiencing adverse events

Including side effects

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

Number of patients requiring unblinding

E.g. because of treatment failure or side effects

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts