Comparison of oral tizanidine and baclofen for post-operative pain management after femoral fracture surgery.

OBJECTIVES: Effective post-operative pain management enhances patients' quality of life and reduces post-operative immobility. To compare the analgesic efficacy of preoperative tizanidine versus baclofen in patients undergoing femoral fracture surgery. DESIGN: In this double-blind clinical trial, 50 patients were randomized to receive either 4 mg tizanidine (Group A) or 25 mg baclofen (Group B) orally before surgery. Post-operative pain was managed with an analgesic pump containing morphine and paracetamol. Pain intensity, nausea, vomiting, pruritus, and analgesic use were assessed upon entering the recovery ward and at 2, 4, 6, 12, 24, and 48 hours post-surgery. RESULTS: Pain intensity, measured by the Visual Analog Scale (VAS), decreased significantly over time in both the tizanidine and baclofen groups (p < 0.001). Although a group-by-time interaction was initially observed (p = 0.042), further analysis revealed this to be a trend rather than a robust difference in the primary outcome. Specifically, at 6, 24, and 48 hours post-surgery, VAS scores were 3.08 ± 1.63, 2.88 ± 1.01, and 2.08 ± 1.04 in the tizanidine group, compared to 3.92 ± 1.29, 3.56 ± 1.16, and 2.84 ± 1.57 in the baclofen group. While uncorrected p-values for these intervals were 0.049, 0.032, and 0.049, respectively, none reached statistical significance after applying the Bonferroni correction for multiple comparisons (p > 0.0167). Additionally, there were no significant differences between groups regarding total morphine consumption or the incidence of adverse effects. CONCLUSIONS: Preoperative administration of 4 mg tizanidine and 25 mg baclofen showed comparable efficacy in post-operative pain management. As this study lacked a placebo control, it cannot confirm the absolute analgesic efficacy of either drug over no treatment. Although tizanidine demonstrated a trend toward lower pain scores at certain intervals, these differences were not statistically significant after adjustment for multiple comparisons. Both drugs exhibited similar safety profiles and supplemental analgesic requirements.