Acute Pain Due to Trauma, Analgesia, Emergency Medical Services, Esketamine, Fentanyl
Conditions
Keywords
Analgesics, Ketanest, Administration, intranasal, Administration, intravenous, Pain management, Drug-Related Side Effects and Adverse Reactions, Anesthetics
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.
Interventions
DRUGFentanyl Citrate
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
DRUGEsketamine
Subjects receive one dose of study medication (fentanyl or esketamine) at baseline, either intravenous or intranasal
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Stichting ZiektekostenVerzekering Krijgsmacht
Ambulance Amsterdam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score as measured with Numeric Rating Scale (NRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score as measured with NRS | 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 pain score as measured with NRS | 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) | 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' |
| 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 |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORMarkus W Hollmann, Prof. dr. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Outcome results
None listed