Scientific paper
Combination tramadol plus acetaminophen for postsurgical pain

https://doi.org/10.1016/j.amjsurg.2003.12.038Get rights and content

Abstract

Background

This multicenter, randomized, double-blind, active- and placebo-controlled trial evaluated tramadol plus acetaminophen (APAP) for orthopedic (n = 153) and abdominal (n = 152) postsurgical pain.

Methods

Patients with moderate pain or greater were randomized to an initial two tablets of 37.5 mg tramadol plus 325 mg APAP (n = 98), codeine 30 mg plus APAP 300 mg (n = 109), or placebo (n = 98); thereafter, they received 1 to 2 tablets every 4 to 6 hours as needed for pain for 6 days. Outcome measures were pain relief and pain intensity, total pain relief, sum of pain intensity differences, and sum of pain relief and pain intensity differences during 4 hours and the daily averages.

Results

Tramadol plus APAP was superior to placebo for total pain relief, sum of pain intensity differences, and sum of pain relief and pain intensity differences (P ≤0.015); tramadol plus APAP and codeine plus APAP did not separate (P ≥0.281). For average daily pain relief, average daily pain intensity, and overall medication assessment, tramadol plus APAP was superior to placebo (P ≤0.038); codeine plus APAP did not separate from placebo (P ≥0.125). Discontinuation because of adverse events occurred in 8.2% of tramadol plus APAP, 10.1% of codeine plus APAP, and 3.0% of placebo patients. Except for constipation (4.1% tramadol plus APAP vs 10.1% codeine plus APAP) and vomiting (9.2% vs 14.7%, respectively), adverse events were similar for active treatments.

Conclusions

Tramadol plus APAP (mean dose 4.4 tablets) was effective and well tolerated for postsurgical pain and showed better tolerability than did codeine plus APAP.

Section snippets

Study design

Treatment of postsurgical pain with tramadol 37.5 mg plus APAP 325 mg (Ultracet; Ortho-McNeil, Raritan, NJ) was compared with codeine 30 mg plus APAP 300 mg and with placebo in a multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group study. The study population consisted of approximately 300 patients in generally good health who had undergone a therapeutic arthroscopic procedure of the knee or shoulder or who had undergone abdominal surgery for inguinal or ventral

Demographics

After randomization (n = 306) was accomplished, the intention-to-treat population (n = 305) consisted of 152 patients undergoing abdominal surgery (49.8%) and 153 patients undergoing orthopedic (50.2%) procedures and included 215 (70.5%) men and 90 (29.5%) women. The patients had a mean age of 47.3 years (range 18 to 79 years), a mean baseline pain visual analog scale score of 62.9 mm, and a baseline pain intensity score of 2.2 (Table 1). The treatment groups were comparable with respect to

Comments

The results of this study show that postsurgical pain associated with arthroscopic procedures of the knee or shoulder or with abdominal hernia surgery was successfully decreased by treatment with 37.5 mg tramadol plus 325 mg APAP tablets. The combination of tramadol plus APAP was superior to placebo as an analgesic as measured by all primary (TOTPAR, SPID, and SPRID) and secondary efficacy outcomes (average daily pain relief, average daily pain intensity, final visit pain intensity, final visit

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    This research was supported by Ortho-McNeil Pharmaceutical, Raritan, NJ.

    Members of the CAPSS-115 Study Group are listed in the Appendix.

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