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Intramuscular diclofenac alone provides comparable short-term pain relief to diclofenac combined with oral or IV paracetamol in acute limb injuries, with no significant difference in efficacy or safety.
A double-blind, randomized controlled trial evaluated whether adding diclofenac with paracetamol improves pain relief compared with diclofenac alone in adult males presenting with acute limb injuries in the emergency department (ED).
The study focused on real-world acute trauma pain management, where NSAIDs, paracetamol, and opioids are commonly used. Researchers specifically assessed whether multimodal analgesia via different routes of paracetamol administration could enhance the effect of intramuscular (IM) diclofenac. The trial enrolled 162 healthy adult males aged 18–65 years. All participants presented to the ED with acute limb injuries and had a baseline numerical rating scale (NRS) pain score ≥5.
Patients were randomized into three equal groups:
Pain was recorded at baseline (t0) and monitored up to 90 minutes (t90), with the primary endpoint assessed at 30 minutes (t30). All three groups demonstrated clinically meaningful pain reduction, but differences between regimens were minimal (Table 1).
Across the observation period (t0–t90), pain trajectories remained similar, and statistical analysis confirmed no pivotal difference among the three groups at t30. Importantly, no participant in any group required rescue analgesia, indicating adequate pain control across all regimens. The safety profile was good throughout the study. No adverse drug reactions, no discontinuations due to intolerance, and no clinically significant complications were noted in any treatment arm.
Although both oral and IV paracetamol slightly increased mean pain reduction numerically compared with placebo, the differences were small and not statistically significant. The findings suggest that adding paracetamol to IM diclofenac does not provide a measurable short-term analgesic advantage in acute limb injury pain in the ED setting. Further large-scale studies are recommended to explore:
Pain Research and Management
A Randomized Trial Evaluating the Synergistic Effect of Parenteral Diclofenac and Paracetamol for Pain Management in Adult Males With Acute Limb Injury
Isma Qureshi et al.
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