Fentanyl or esketamine for traumatic pain trial

Conditions

Acute traumatic pain

Brief summary

Difference in NRS score between baseline and 10 minutes after administration of study medication

Detailed description

Difference in NRS score between baseline and 20 minutes after first dose of study medication, Difference in NRS score between baseline and arrival at the hospital, Relative change in NRS score between baseline and 10 minutes after first dose of study medication, Relative change in NRS score between baseline and 20 minutes after first dose of study medication, Relative change in NRS score between baseline and arrival at the hospital, Number of subjects requiring a second dose of study medication, Number of subjects requiring unblinding because of treatment failure, Number of subjects experiencing adverse events, need for unblinding or intervention, Patient satisfaction with prehospital analgesia

MN de Grunt, Nurseda Risvanoglu, JA Siegers, Marije W. Kroon, MP Merkus et al. (8 authors)

BMJ Military Health2025-10-01

10.1136/bmjmilitary-2025-nato.39

Interventions

DRUGNatriumchloride 0

DRUG9% oplossing voor injectie

DRUGFentanyl hameln 50 microgram/ml

DRUGoplossing voor injectie

DRUGParacetamol Sanias 500 mg

DRUGtabletten

DRUGEsketiv 25 mg/ml

DRUGESKETAMINE

DRUGDiclofenacnatrium Aurobindo 50 mg

DRUGmaagsapresistente tabletten.

DRUGDiclofenac Na CF 25 mg/ml

DRUGParacetamol B. Braun 10 mg/ml

DRUGoplossing voor infusie

DRUGSODIUM CHLORIDE

DRUGFENTANYL CITRATE

DRUGMidazolam Aurobindo 5 mg/ml

DRUGoplossing voor injectie/infusie of rectale toediening

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in NRS score between baseline and 10 minutes after administration of study medication	—

Secondary

Measure	Time frame
Difference in NRS score between baseline and 20 minutes after first dose of study medication, Difference in NRS score between baseline and arrival at the hospital, Relative change in NRS score between baseline and 10 minutes after first dose of study medication, Relative change in NRS score between baseline and 20 minutes after first dose of study medication, Relative change in NRS score between baseline and arrival at the hospital, Number of subjects requiring a second dose of study medication, Number of subjects requiring unblinding because of treatment failure, Number of subjects experiencing adverse events, need for unblinding or intervention, Patient satisfaction with prehospital analgesia	—

Measure

Time frame

Difference in NRS score between baseline and 20 minutes after first dose of study medication, Difference in NRS score between baseline and arrival at the hospital, Relative change in NRS score between baseline and 10 minutes after first dose of study medication, Relative change in NRS score between baseline and 20 minutes after first dose of study medication, Relative change in NRS score between baseline and arrival at the hospital, Number of subjects requiring a second dose of study medication, Number of subjects requiring unblinding because of treatment failure, Number of subjects experiencing adverse events, need for unblinding or intervention, Patient satisfaction with prehospital analgesia

—

Countries

Netherlands

Outcome results

None listed