RESUMEN
STUDY DESIGN: A single center, double-blind, randomized, placebo-controlled trial. OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of Ultracet(TM) compared with a placebo in the treatment of acute pain after spinal surgery. SUMMARY OF LITERATURE REVIEW: Ultracet(TM) is a combination drug of Tramadol and Acetaminophen, and the synergistic effect in pain control was demonstrated by animal experiments. MATERIALS AND METHODS: Seventy-six patients who satisfied the selection and exclusion criteria after spinal surgery were enrolled in this study. The patients measured perceptible pain relief time and meaningful pain relief time using a two stopwatch technique. The pain intensity (PI) and pain relief (PAR) were recorded at 30 minutes and then hourly over a 4 hour period, and the pain intensity difference (PID), the sum of the pain intensity difference (SPID), and the total pain relief (TOPAR) were also checked. RESULTS: The study and control group comprised of 56 and 20 patients, respectively. The baseline pain intensity was an average of 5.9+/-1.2 in the study group and 6.1+/-1.4 in the control group (p=0.683). The final pain intensity was 2.5+/-2.4 and 4.1+/-2.2 in the study and control group, respectively. The study group was superior to placebo (p=0.008). In addition, the study group was statistically superior in terms of the PID (p=0.025), SPID (p=0.028), and TOPAR (p=0.048), particularly over 2 hours, as well as the overall assessment (p=0.005). The median time of the meaningful pain relief time was 90 and 193 minutes in the study and control group, respectively. CONCLUSIONS: The analgesic efficacy of Ultracet(TM) was superior to the placebo on the SPID, TOPAR, and the subjects' overall assessments over the 4 hour observation period. These results suggest that Ultracet(TM) is an effective therapeutic option for the management of acute pain after spinal surgery without serious complications.