Tags

Type your tag names separated by a space and hit enter

A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain.
Pain. 2004 Jun; 109(3):250-7.PAIN

Abstract

The objective of this study was to compare the analgesic efficacy of tramadol/acetaminophen (APAP) (total dose 75 mg/650 mg) and tramadol (total dose 100 mg) for the control of pain after oral surgery. A total of 456 patients with moderate-to-severe pain within 5 h after extraction of two or more third molars were randomized to receive two identical encapsulated tablets containing tramadol/APAP 37.5 mg/325 mg, tramadol 50 mg, or placebo. Tramadol/APAP was superior to tramadol (P < 0.001) or placebo (P < 0.001) on all efficacy measures: total pain relief (PAR) over 6 h (7.4, 2.5, and 1.5, respectively, on a scale of 0-24); sum of pain intensity differences (PIDs) (3.1, 0.6, and 0.1, respectively, on a scale of -6 to 18); and sum of PAR and PID (10.5, 3.1, and 1.6, respectively, on a scale of -6 to 42). Median times to onset of perceptible and meaningful PAR were 37.6 and 126.5 min, respectively, for the tramadol/APAP group (P < 0.001) for each, compared with tramadol and placebo arms). The most common adverse events with active treatment were nausea, dizziness, and vomiting; these events occurred more frequently in the tramadol group than in the tramadol/APAP group. This study established the superiority of tramadol/APAP 75 mg/650 mg over tramadol 100 mg in the treatment of acute pain following oral surgery.

Authors+Show Affiliations

Austin Oral Surgery Associates, 706A Ben White Blvd West, Austin, TX 78704, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15157685

Citation

Fricke, James R., et al. "A Double-blind Placebo-controlled Comparison of Tramadol/acetaminophen and Tramadol in Patients With Postoperative Dental Pain." Pain, vol. 109, no. 3, 2004, pp. 250-7.
Fricke JR, Hewitt DJ, Jordan DM, et al. A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain. Pain. 2004;109(3):250-7.
Fricke, J. R., Hewitt, D. J., Jordan, D. M., Fisher, A., & Rosenthal, N. R. (2004). A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain. Pain, 109(3), 250-7.
Fricke JR, et al. A Double-blind Placebo-controlled Comparison of Tramadol/acetaminophen and Tramadol in Patients With Postoperative Dental Pain. Pain. 2004;109(3):250-7. PubMed PMID: 15157685.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain. AU - Fricke,James R,Jr AU - Hewitt,David J, AU - Jordan,Donna M, AU - Fisher,Alan, AU - Rosenthal,Norman R, PY - 2003/08/21/received PY - 2003/12/03/revised PY - 2004/01/05/accepted PY - 2004/5/26/pubmed PY - 2004/10/1/medline PY - 2004/5/26/entrez SP - 250 EP - 7 JF - Pain JO - Pain VL - 109 IS - 3 N2 - The objective of this study was to compare the analgesic efficacy of tramadol/acetaminophen (APAP) (total dose 75 mg/650 mg) and tramadol (total dose 100 mg) for the control of pain after oral surgery. A total of 456 patients with moderate-to-severe pain within 5 h after extraction of two or more third molars were randomized to receive two identical encapsulated tablets containing tramadol/APAP 37.5 mg/325 mg, tramadol 50 mg, or placebo. Tramadol/APAP was superior to tramadol (P < 0.001) or placebo (P < 0.001) on all efficacy measures: total pain relief (PAR) over 6 h (7.4, 2.5, and 1.5, respectively, on a scale of 0-24); sum of pain intensity differences (PIDs) (3.1, 0.6, and 0.1, respectively, on a scale of -6 to 18); and sum of PAR and PID (10.5, 3.1, and 1.6, respectively, on a scale of -6 to 42). Median times to onset of perceptible and meaningful PAR were 37.6 and 126.5 min, respectively, for the tramadol/APAP group (P < 0.001) for each, compared with tramadol and placebo arms). The most common adverse events with active treatment were nausea, dizziness, and vomiting; these events occurred more frequently in the tramadol group than in the tramadol/APAP group. This study established the superiority of tramadol/APAP 75 mg/650 mg over tramadol 100 mg in the treatment of acute pain following oral surgery. SN - 0304-3959 UR - https://www.unboundmedicine.com/medline/citation/15157685/A_double_blind_placebo_controlled_comparison_of_tramadol/acetaminophen_and_tramadol_in_patients_with_postoperative_dental_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304395904000181 DB - PRIME DP - Unbound Medicine ER -