Objective: The aim of the study was to investigate the safety and efficacy of pregabalin versus placebo in post-traumatic peripheral neuropathic pain (PTNP).

Methods: PubMed, Cochrane Library, Web of Science, and Google Scholar were searched for relevant evidence up to January 2022. The Cochran tool was used to assess the quality of randomized clinical trials (RCTs). Data analysis was performed using Comprehensive Meta-Analysis software.

Results: Three RCTs involving 821 patients were included in the meta-analysis. A significant difference was observed between pregabalin and placebo in terms of the pain score (the standardized mean difference [SMD] = -0.14, 95% CI: 0.28 to -0.006, p = 0.04) and sleep interference (MD = -0.25, 95% CI: -0.39 to -0.11, p = 0.00). There was also a significant difference between pregabalin and placebo regarding somnolence (risk ratio [RR] = 2.78; 95% CI: 1.64-4.71, p = 0.00), dizziness (RR = 4.13; 95% CI: 2.71-6.28, p = 0.00), and disturbance in attention (RR: 2.97; 95% CI: 1.02-8.65, p = 0.04). However, no significant difference was observed between pregabalin and placebo in terms of headache (RR = 1.20; 95% CI: 0.70-2.06, p = 0.50), fatigue (RR = 1.42; 95% CI: 0.82-2.47, p = 0.20), nausea (RR = 1.52; 95% CI: 0.88-2.62, p = 0.13), constipation (RR = 1.84; 95% CI: 0.78-4.29, p = 0.15), and discontinuation (RR = 1.52; 95% CI: 0.45-5.06, p = 0.49).

Conclusion: Compared with placebo, pregabalin showed better efficacy in reducing PTNP and improving sleep interference. However, it was associated with higher adverse events. Further RCTs are needed to confirm these findings.

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