FORE-PAIN trial

Phase 1

Recruiting

Conditions: Acute traumatic pain
Therapeutic area: Not possible to specify

Registration Number: CTIS2022-500176-63-00

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 608

Inclusion Criteria

Age =18 years, Pain caused by trauma that occurred on the same day, Administration of a strong opioid or esketamine is required for analgesia as determined by prehospital personnel, Patient will be transported to a hospital

Exclusion Criteria

Reported or estimated weight =40 or >100 kg, Subject does not understand Dutch or English, Subject is known to have previously declined participation in medical research, Inability to report pain score, Inability to give intranasal or intravenous medication, Known severe cardiovascular disease, Pre-eclampsia, Glasgow Coma Scale score < 11, Subject does not provide verbal consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine whether intranasal (IN) fentanyl, intravenous (IV) esketamine and intranasal esketamine are non-inferior to intravenous fentanyl for analgesia in acute traumatic pain in the prehospital environment;Secondary Objective: Determine whether - compared to fentanyl IV - fentanyl IN, esketamine IV and esketamine IN provide similar patient satisfaction considering analgesia, To determine whether - compared to fentanyl IV - fentanyl IN, esketamine IV and esketamine IN are equally safe;Primary end point(s): Difference in NRS score between baseline and 10 minutes after administration of study medication

Secondary Outcome Measures

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