Comparative evaluation of analgesic efficacy of tramadol and diclofenac-sodium in post-operative orthopedic patients

摘要

Background: Post-operative pain management is an important consideration in the orthopedic department. The purpose of this study was to compare the analgesic efficacy of tramadol with diclofenac sodium in patients with postoperative orthopedic pain. Methods: A hospital based, prospective, observational study was undertaken in Department of Orthopedics for a period of one year. A group of 60 patients having post-operative pain intensity assessed as 6cm or more on a 10cm visual analogue scale (VAS) were assigned to receive either tramadol thrice a day (n=30) or diclofenac sodium thrice a day (n=30). Both drugs were administered parenterally for initial 24hr, then orally for next 96 hr. The primary efficacy outcome measures were pain intensity difference assessed at 2hr, 4hr, 8hr, 16hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr, 72hr, 80hr, 96hr, 104hr, 112hr and 120hr using a VAS and sum of pain intensity differences assessed at 8hr, 24hr, 48hr, 72hr, 96hr and 120hr whereas secondary efficacy measures included maximum fall in pain intensity, number of patients who required rescue medication and their quality of sleep in the night. Results: Mean pain intensity differences assessed on 10cm VAS were significantly better for tramadol group compared to diclofenac group at all the time points except 88 hr. Sum of pain intensity differences over 8hr, 24hr, 48hr, 72hr, 96hr and 120 hr for the tramadol group was significantly superior than diclofenac group. Maximum fall in pain intensity score was also significantly superior in the tramadol group as compared to the diclofenac group. However, no patients required rescue medication in either of the groups. Patient’s quality of sleep improved with both drugs but tramadol produced significantly better quality of sleep every night than did diclofenac. Both the study medications produced effective analgesia and were well tolerated with no incidence of serious adverse effects throughout the study. Conclusions: Tramadol has a more pronounced analgesic effect than diclofenac. Thus, tramadol can be considered as an effective alternative to traditional NSAIDs in the treatment of post-operative pain.