Table 4 Study endpoints
Primary endpoint | • Changes in pain score from T0 to T10 |
|---|---|
Secondary endpoints | • Changes in pain score from T0 to T5, T20, T30 and end of mission TED • Need for additional analgesia not in the regimen of the allocated treatment group • Differences in time arrival to administration of IMP registration of AE and SAE during study period until end of intervention • Time from ambulance personnel arrival to first measure > 2 points reduction in NRS from baseline • Change in level of sedation from T0 to T10 and T30 • Change in RR T0 to T10 and T30 • Change in SBP T0 to T10 and T30 • Likert scale of HCP satisfaction at end of mission • Likert scale of patient satisfaction at end of mission • Registration of AE and SAE during study period until end of intervention |
Exploratory endpoints | • Analyze primary and secondary efficacy endpoints stratified by diagnosis or diagnosis groups • Proportion of patient receiving rescue treatment related to procedures (reposition of fractures, relocation, etc.) • Attempts of vascular cannulation access • Change in NRS and time to a significant NRS reduction compared to level of competence • Ambulance personnel competence and patient satisfaction • Analyze primary and secondary efficacy endpoints stratified by level of troponin after ED admission and sign of ACS on ECG at scene • Analyze AE and SAE in relation to concomitant therapy and other non-IMP determinants |