J Korean Soc Spine Surg.  2007 Sep;14(3):137-143. 10.4184/jkss.2007.14.3.137.

Effect of Tramadol/Acetaminophen Combination Drug in Acute Pain After Spinal Surgery

• Chung JY
• Lee JJ
• Seo HY
• Shon SJ
• Chung EK

• KMID: 1941644
• DOI: http://doi.org/10.4184/jkss.2007.14.3.137

Abstract

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.

Keyword

Spinal disease; Surgical treatment; Acute pain; Randomized double-blind test; Ultracet(TM)

MeSH Terms

Acetaminophen
Acute Pain*
Animal Experimentation
Humans
Spinal Diseases
Tramadol
Acetaminophen
Tramadol

Figure

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  Formula 1. Estimation of sample size needed in a randomized trial.

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  Fig. 1. The graph for mean PID scores

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  Fig. 2. The graph for mean PAR scores

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  Fig. 3. Overall assessments of the study medication

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