Table 1 WHO trial registration data set
Data Category | Information |
|---|---|
Primary registry and trial identifying number | ISRCTN14124474 |
Date of registration in primary registry | 22/10/2020 |
Secondary identifying numbers | EudraCT number: 2020-000154-10 IRAS ID: 1003404 CPMS ID: 46938 REC reference: 20/WS/0126 |
Source of monetary or material support | National Institute for Health Research (NIHR) |
Primary sponsor | University of Warwick |
Secondary sponsor | N/A |
Contact for public queries | packman@warwick.ac.uk |
Contact for scientific queries | m.a.smyth@warwick.ac.uk |
Public title | PACKMaN |
Scientific title | Paramedic Analgesia Comparing Ketamine and MorphiNe in trauma: PACKMaN |
Countries of recruitment | UK |
Health condition or problem studied | Acute severe pain from traumatic injury in adults |
Interventions | Control: Pre-hospital morphine sulphate (0.10Â mg/kg) Intervention: Pre-hopsital ketamine hydrochloride (0.15Â mg/kg) |
Key inclusion and exclusion criteria | Inclusion: Age ≥ 16 Patient reports a pain score ≥ 7/10 on a 0–10 numeric rating scale following acute traumatic injury Intravenous (IV) or intraosseous (IO) access obtained Determined by a paramedic to require IV morphine or equivalent Exclusion: Known or suspected pregnancy |
Unable to articulate severity of pain using the 0–10 numeric rating scale |  |
Lack of capacity due to a reason other than pain IV/IO ketamine or opioid analgesia immediately prior to randomisation Known contraindication to ketamine or morphine as per the SmPC Patient declines participation Known prisoner | Â |
Study type | Interventional, blinded, randomised, individual assignment. Phase III trial |
Date of first enrolment | 10-Nov-21 |
Target sample size | 446 |
Current recruitment | 362 |
Recruitment status | Recruiting |
Primary outcome | Outcome name: Sum of pain intensity difference score Metric/method of measurement: using a 0–10 numerical rating scale Timepoint: From randomisation to arrival at hospital |
Key secondary outcomes | Effectiveness of pain relief and overall patient experience from randomisation to arrival at hospital Incidence of side effects and adverse events Resource use Longer term outcomes |
Ethics Review | Status: Approved Date of Approval: 01/09/2020 Committee: West of Scotland Research Ethics Committee Contact: wosrec1@ggc.scot.nhs.uk |