Paracetamol versus paracetamol/tramadol in postoperative intertrochanteric fracture: A noninferiority, randomized, controlled, double-blind study

Abstract

Background: One of the most common osteoporotic fractures among the elderly is hip fracture with tramadol frequently being prescribed for these patients. To decrease the risk of falling from tramadol, this study aimed to ascertain the effectiveness of paracetamol compared to paracetamol/tramadol for pain control following hip fixation surgery. Method: This was a noninferiority, double-blind, randomized, controlled trial at a tertiary care hospital. All patients were recruited between February 2020 and March 2022. Patients were randomly assigned to paracetamol alone (Group A) or paracetamol/tramadol (Group B). All patients in both groups followed the same protocol for the first two days after surgery. To ascertain differences in pain control between the two groups, different regimens were followed from postoperative days 3–5. Pain scores were assessed by a visual analog scale (VAS). All patients were asked to complete a satisfaction questionnaire on day 5. Result: A total of 30 patients were randomly allocated into Group A (paracetamol alone) and 30 into Group B (paracetamol + tramadol). The mean pain score for Group A was 5.85 ± 0.52 and 5.35 ± 0.74 for Group B. Mean cumulative doses in Group A were 4.50 ± 1.33 and 4.06 ± 1.18 in Group B. Although the mean satisfaction with pain management was higher in Group B, this was not statistically significant. Conclusion: VAS scores from Group A were slightly higher than Group B. Based on a 2.0-point noninferiority margin of pain, paracetamol alone was not inferior to paracetamol/tramadol in postoperative intertrochanteric fracture.