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Combination tramadol plus acetaminophen for postsurgical pain.
Am J Surg. 2004 Apr; 187(4):521-7.AJ

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 < or =0.015); tramadol plus APAP and codeine plus APAP did not separate (P > or=0.281). For average daily pain relief, average daily pain intensity, and overall medication assessment, tramadol plus APAP was superior to placebo (P < or =0.038); codeine plus APAP did not separate from placebo (P > or =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.

Authors+Show Affiliations

Department of Surgery, University of North Texas Health Science Center, 855 Montgomery St., Fort Worth, TX 76107, USA. adsmith@hsc.unt.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15041504

Citation

Smith, Adam B., et al. "Combination Tramadol Plus Acetaminophen for Postsurgical Pain." American Journal of Surgery, vol. 187, no. 4, 2004, pp. 521-7.
Smith AB, Ravikumar TS, Kamin M, et al. Combination tramadol plus acetaminophen for postsurgical pain. Am J Surg. 2004;187(4):521-7.
Smith, A. B., Ravikumar, T. S., Kamin, M., Jordan, D., Xiang, J., & Rosenthal, N. (2004). Combination tramadol plus acetaminophen for postsurgical pain. American Journal of Surgery, 187(4), 521-7.
Smith AB, et al. Combination Tramadol Plus Acetaminophen for Postsurgical Pain. Am J Surg. 2004;187(4):521-7. PubMed PMID: 15041504.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination tramadol plus acetaminophen for postsurgical pain. AU - Smith,Adam B, AU - Ravikumar,Thanjavur S, AU - Kamin,Marc, AU - Jordan,Donna, AU - Xiang,Jim, AU - Rosenthal,Norman, AU - ,, PY - 2003/04/17/received PY - 2003/10/17/revised PY - 2004/3/26/pubmed PY - 2004/5/7/medline PY - 2004/3/26/entrez SP - 521 EP - 7 JF - American journal of surgery JO - Am. J. Surg. VL - 187 IS - 4 N2 - 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 < or =0.015); tramadol plus APAP and codeine plus APAP did not separate (P > or=0.281). For average daily pain relief, average daily pain intensity, and overall medication assessment, tramadol plus APAP was superior to placebo (P < or =0.038); codeine plus APAP did not separate from placebo (P > or =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. SN - 0002-9610 UR - https://www.unboundmedicine.com/medline/citation/15041504/Combination_tramadol_plus_acetaminophen_for_postsurgical_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002961003006329 DB - PRIME DP - Unbound Medicine ER -