A comparative study of oral tramadol and ibuprofen in postoperative pain in operations of lower abdomen.

The objective of this study was to assess efficacy and safety of oral tramadol in postoperative pain in operations of lower abdomen as compared to oral ibuprofen. Eighty patients undergoing operations in the lower abdomen under spinal anaesthesia were randomly assigned to two parallel groups--ibuprofen 400 mg thrice daily and tramadol 100 mg thrice daily, both orally after food. Treatment was given single-blind for 5 days in the postoperative period. Patient's perception of pain scored byvisual analogue scale (VAS) and wound tenderness assessed by a 3-point ordinal scale were the primary efficacy parameters. A steady decline in VAS pain score from baseline to study end (99.7 +/- 2.75 to 54.4 +/- 9.71 in the ibuprofen group and 97.3 +/- 3.14 to 52.5 +/- 9.95 in tramadol group) indicated good analgesic efficacy in both groups. Within groups, comparisons showed highly significant difference in VAS score between baseline and each of the subsequent assessment time points (p < 0.001). Between groups differences were not significant at any point. There were no intergroup differences in wound tenderness at baseline or at study end. Rescue medication was needed by 6 subjects on ibuprofen but none on tramadol (p = 0.011). Both regimens were well tolerated. It can be thus concluded that oral tramadol is safe, effective and comparable to ibuprofen as analgesic for relieving pain in the postoperative period in patients undergoing operations in the lower abdomen. The need for rescue medication for breakthrough pain may be less with tramadol.

RCT Entities:   Population Interventions Outcomes