Efficacy and Safety of Intravenous Paracetamol Compared with Intramuscular Tramadol for Labor Analgesia: A Randomized Controlled Trial
Abstract
Abstract Pain management is essential in labor. While regional analgesia is the gold standard, it often requires resources and expertise not widely available in low-resource settings. Intravenous paracetamol and intramuscular tramadol are potential alternatives, but their comparative efficacy and safety remain inadequately studied. To compare the efficacy and safety of intravenous paracetamol versus intramuscular tramadol for labor analgesia. This open-label, non-inferiority randomized controlled trial included 189 parturients in active labor. Participants were randomized 1:1 to receive 1000 mg intravenous paracetamol (Group A) or 100 mg intramuscular tramadol (Group B). Pain intensity was assessed using the Visual Analog Scale at baseline/admission (0 h), and at three points thereafter (1, 2, and 3 h). The primary outcome was mean pain duration; secondary outcomes included maternal and fetal side effects, need for rescue analgesia, and patient satisfaction. Statistical analysis was done using the Statistical Package for Social Sciences version 28 for Windows at 95% confidence interval (CI). Analysis was by intention-to-treat. A P value of <0.05 was considered statistically significant. There were no significant differences in pain scores between the paracetamol and tramadol groups at baseline (0 h) or at subsequent assessments (1, 2, and 3 h). The mean pain scores were as follows: 8.21 ± 1.56 versus 8.24 ± 1.48 ( P = 0.907) at baseline; 7.42 ± 1.67 versus 7.27 ± 1.72 ( P = 0.549) at 1 h; 7.48 ± 1.83 versus 7.44 ± 1.82 ( P = 0.920) at 2 h; and 7.53 ± 2.30 versus 7.79 ± 2.40 ( P = 0.561) at 3 h. However, fewer women in the paracetamol group required rescue analgesia compared to the tramadol group (19.7% vs. 31.9%; relative risk = 0.53, 95% CI: 0.24–0.86; P < 0.010). Maternal side effects—including nausea, vomiting, and sedation—and neonatal appearance, pulse, grimace, activity, respiration scores were comparable between the two groups ( P > 0.05). Intravenous paracetamol is a safe and effective alternative to intramuscular tramadol for labor analgesia, with comparable maternal and neonatal outcomes. Larger multicenter studies are recommended to enhance external validity. ClinicalTrials.gov ID: NCT06371144.