PACKMaN
Trial question
What is the role of ketamine administered by paramedics in patients with acute severe trauma pain?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 449
449 patients (241 female, 208 male).
Inclusion criteria: patients with acute traumatic injury who reported severe pain.
Key exclusion criteria: pregnancy; inability to articulate severity of pain; lack of capacity due to a reason other than pain; incarceration; no informed consent; contraindication to study drugs; receipt of parenteral ketamine or opioids prior to randomization.
Interventions
N=219 ketamine (maximum available dose of 30 mg IV).
N=230 morphine (maximum available dose of 20 mg IV).
Primary outcome
Mean Sum of Pain Intensity Difference score on arrival to hospital
3.5 points
3.4 points
3.5 points
2.6 points
1.8 points
0.9 points
0.0 points
Ketamine
Morphine
No significant
difference ↔
No significant difference in mean Sum of Pain Intensity Difference score on arrival to the hospital (3.5 points vs. 3.4 points; MD 0.1, 95% CI -0.4 to 0.6).
Secondary outcomes
No significant difference in mean Total Pain Relief score (1.4 points vs. 1.4 points; MD 0.03, 95% CI -0.2 to 0.2).
No significant difference in achievement of minimal improvement analgesia (91% vs. 91%; OR 1.9, 95% CI 0.5 to 2).
No significant difference in median minutes to minimal improvement (6 minutes vs. 8 minutes; HR 1.1, 95% CI 0.9 to 1.3).
Safety outcomes
No significant difference in serious adverse events.
Significant differences in desaturation (7% vs. 16%), hypotension (3% vs. 10%), adverse behavioral reactions (10% vs. 1%).
Conclusion
In patients with acute traumatic injury who reported severe pain, ketamine was not superior to morphine with respect to mean Sum of Pain Intensity Difference score on arrival to the hospital.
Reference
Michael A. Smyth, Hannah Noordali, Kath Starr et al. Paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN): a randomised, double-blind, phase 3 trial. Lancet Reg Health Eur. 2025 June:53:101265.
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