A randomized, clinical trial of ketorolac tromethamine vs ketorolac trometamine plus complex B vitamins for cesarean delivery analgesia

BACKGROUND: Ketorolac is widely used for postoperative analgesia in patients who undergo cesarean delivery. In countries where the use of opioids is considerably restricted, alternatives to narcotics are required. AIM: We hypothesize that the addition of complex B synergize the analgesic effect of ketorolac in postoperative cesarean patients, thus requiring a smaller dose of the anti-inflammatory agent, and therefore decreasing the potential side effects of ketorolac. METHODS: A randomized clinical trial with 100 patients undergoing a primary elective cesarean delivery enrolled in the study. Pain was assessed in the recovery room and then they were randomized to receive ketorolac 30 mg intramuscular (i.m.) or 15 mg of ketorolac plus complex B vitamin (CBV). The pain score with an analog scale was assessed 1, 2, 6, 12, 18, and 24 h after the baseline. The student's t test was performed to compare the demographic differences between the 2 means. RESULTS: 100 patients were included in the study, showing no statistical differences in the demographics. The patient's pain score at 1, 2, 6, 12, 18 and 24 hours showed no statistical differences between the control group (ketorolac 30mg) compared to the group of ketorolac 15mg and complex B vitamins. No changes in the coagulation studies were found in both groups. CONCLUSION: The present study demonstrates that ketorolac 30 mg and ketorolac 15 mg plus complex B vitamins can provide acceptable analgesia in many patients with severe pain.