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KMID : 0388720070140030137
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Journal of Korean Society of Spine Surgery
2007 Volume.14 No. 3 p.137 ~ p.146
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Effect of Tramadol/Acetaminophen Combination Drug in Acute Pain After Spinal Surgery
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Chung Jae-Yoon
Lee Jae-Joon
Seo Hyoung-Yeon
Sohn Seok-Joon
Chung Eun-Kyung
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Abstract
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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™ compared with a placebo in the treatment of acute pain after spinal surgery.
Summary of Literature Review: Ultracet™ 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™ 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™ is an effective therapeutic option for the management of acute pain after spinal surgery without serious complications.
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KEYWORD
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Spinal disease, Surgical treatment, Acute pain, Randomized double-blind test, Ultracet™
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