PP44 Involving newly-qualified paramedics in prehospital randomised controlled trials: an analysis of training, enrolment and safety data within the paramedic analgesia comparing ketamine and MorphiNe in trauma (PACKMaN) study

<h3>Background</h3> The PACKMaN Study is a multi-centre, randomized, double blinded control drug trial which compared the clinical and cost effectiveness of ketamine against morphine for severe pain in adults with acute traumatic injury. This study was conducted in collaboration by Warwick Clinical Trials Unit (WCTU) West Midlands Ambulance Service University NHS Foundation Trust (WMAS) and Yorkshire Ambulance Service NHS Trust (YAS). Both Ambulance services choose to include Newly Qualified Paramedics (NQPs) and Experienced Paramedics (EPs) in the recruitment of the PACKMaN Trial. NQPs are HCPC registered paramedics that are expected to work autonomously on frontline ambulances with up to 2 years post qualification experience. In the PACKMaN trial, NQPs were permitted to enrol to the study after completing relevant training as they would be expected to use the study intervention, were it brought into clinical practice. Currently evidence is limited around the NQP role and any potential link with research participant safety. <h3>Methods</h3> An analysis was conducted of NQPs contribution to enrolment, to include review of protocol compliance and safety events, broken down by post-registration period of the paramedic: NQPs (&lt;2 years) or experienced paramedics (EPs - &gt;2 years). Both ambulance services provided the following data: trained paramedic numbers, enrolled participant numbers, adverse events (AEs)and serious adverse events (SAEs), and protocol non-compliances. <h3>Results</h3> 160/489 (32.7%) of trial-trained paramedics were NQPs. 199/458 (43.4%) of participants were enrolled by NQPs. Of participants enrolled by NQPs, 45.7.32% experienced an AE, versus 49.4% of participants enrolled by EPs . 4.0% of all NQP-enrolled participants experienced an SAE, versus 1.5% of all those enrolled by EPs. Protocol non-compliances were 6 (3.0%) in NQPs and 3 (1.2%) in EPs. <h3>Conclusion</h3> NQP’s made an important contribution to this study, both in terms of patient enrolment, but also in improving the generalisability of the study findings. We found similar levels of adverse events in NQP versus EPs. We found no evidence of safety implications to including NQPs in this trial. Study training and participation was optional; different considerations may apply for research where participation is mandated.