Tramadol versus low dose tramadol-paracetamol for patient controlled analgesia during spinal vertebral surgery.

Pain intensity may be high in the postoperative period after spinal vertebral surgery. The aim of the study was to compare the effectiveness and cost of patient controlled analgesia (PCA) with tramadol versus low dose tramadol-paracetamol on postoperative pain. A total of 60 patients were randomly divided into two groups. One group received 1.5 mg/kg tramadol (Group T) while the other group received 0.75 mg/kg tramadol plus 1 g of paracetamol (Group P) intravenously via a PCA device immediately after surgery and the patients were transferred to a recovery room, Tramadol was continuously infused at a rate of 0.5 mL/h in both groups, at a dose of 10 mg/mL in Group T and 5 mg/mL in Group P. The bolus and infusion programs were adjusted to administer a 1 mL bolus dose of tramadol with a lock time of 10 minutes. In Group P, 1 g of paracetamol was injected intravenously every 6 hours. The four-point nausea scale, numeric rating scale for pain assessment, Ramsey sedation scale, blood pressure, heart rate, respiration rate, peripheral oxygen saturation values and side effects were recorded at 0, 15 and 30 minutes, and at 1, 2, 4, 6, 12, 18 and 24 hours. The time to reach an Aldrete score of 9 was also recorded. A cost analysis for both groups was performed. In Group P, the numeric rating scale scores were significantly lower than that in Group T at 0 and 15 minutes. The number of side effects, additional analgesic requirement and the total dose of tramadol were lower in Group P than in Group T. However, the total cost of postoperative analgesics was significantly higher in Group P than in Group T (p < 0.001). We conclude that PCA using tramadol-paracetamol could be used safely for postoperative pain relief after spinal vertebral surgery, although at a higher cost than with tramadol alone. Copyright 2010 Elsevier. Published by Elsevier B.V. All rights reserved.

RCT Entities:   Population Interventions Outcomes