Comparison between paracetamol,paracetamol-codeine and paracetamol-caffeine in the treatment of acute post-traumatic pain: A randomized controlled trial

Abstract

Objective

To compare three therapeutic strategies in the management of acute post-traumatic pain at emergency department (ED) discharge.

Methods

We conducted a prospective, randomized, controlled trial including patients ≥18 years with acute post-traumatic pain. They were randomized to receive oral paracetamol (n = 506), paracetamol-codeine (P-Cod group; n = 489) and paracetamol-caffeine (P-Caf group; n = 505) for 7 days. The primary endpoint was the rate of participants achieving at least 50% reduction in Numerical Rating Scale (NRS) from baseline by the 7th day after ED discharge. Secondary endpoints included the need for rescue analgesics, adverse effects, and patient satisfaction.

Results

At day-7, success rate were 85.8%, 93.9%, and 90.1% in paracetamol, P-Cod, and P-Caf groups, respectively. The differences were statistically significant between the paracetamol and P-Caf groups (p = .02), the paracetamol and P-Cod groups (p ≤ .001); and the P-Cod and P-Caf groups (p = .04). The need for rescue analgesics was significantly higher in paracetamol group (47.6%) compared to P-Caf (7.5%) and P-Cod group (7.4%); whereas, no significant difference was found between P-Cod and P-Caf groups. Most of the adverse effects (95.7%) were observed in P-Cod group. Finally, patients treated with paracetamol alone were the least satisfied.

Conclusion

The combination of codeine or caffeine with paracetamol was equally effective and superior to paracetamol alone. If we consider the better tolerance, paracetamol combined with caffeine appears to be a suitable analgesic option for post trauma patients.