Trial Title

Paramedic Analgesia Comparing Ketamine and MorphiNe in trauma : PACKMaN

Hypothesis

Ketamine is superior to morphine for the management of acute severe pain from traumatic injury treated by NHS paramedics.

Trial Design

Multi-centre, pragmatic, controlled, blinded, trial, with economic evaluation and internal pilot.

Trial Participants

Adult patients (age ≥16 years) with severe pain following acute traumatic injury

Setting

West Midlands and Yorkshire NHS Ambulance Services

Inclusion criteria

1. Age ≥16

2. Patient reports a pain score ≥7/10 on a 0-10 numeric rating scale following acute traumatic injury

3. Intravenous or intraosseous access obtained

4. Determined by a paramedic to require IV morphine or equivalent

Exclusion criteria

1. Known or suspected pregnancy

2. Unable to articulate severity of pain using the 0-10 numeric rating scale

3. Lack of capacity due to a reason other than pain

4. IV/IO ketamine or opioid analgesia immediately prior to randomisation

5. Known contraindication to ketamine or morphine as per the SmPC

6. Patient declines participation

7. Known prisoner

Sample size

446 (223 each arm with 1:1 randomisation)

Interventions being assessed

Pre-hospital ketamine hydrochloride (0.15mg / kg) or morphine sulphate (0.10mg / kg)

Measurement of outcomes and costs

Primary Outcome

• Effectiveness of pain relief from randomisation to arrival at hospital as measured by Sum of Pain Intensity Difference (SPID) score (using a 0-10 numerical rating scale)

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

Follow-up Duration

6 months from randomisation

Trial Period

01/11/2020 – 30/06/2024

The trial has now closed to recruitment