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Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain.

Abstract

OBJECTIVE

To determine analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with acetaminophen/codeine 600/60 mg, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group study.

STUDY DESIGN

Patients (N = 390) experiencing moderate or severe pain postextraction of 2 or more third molars, with at least 1 mandibular impaction, were randomized to placebo (n = 30), rofecoxib (n = 180), or codeine/acetaminophen 60/600 mg (n = 180). Time to confirmed perceptible pain relief, and patient evaluations of pain intensity, pain relief, and global assessments were recorded.

RESULTS

For total pain relief over 6 hours (primary end point), rofecoxib was superior to codeine/acetaminophen (15.5 vs 10.7; P < .001). Rofecoxib was statistically significantly superior to codeine/acetaminophen with respect to TOPAR4, patient global assessment, peak pain relief, and duration of analgesic effect. Median onset of analgesia was similar for both drugs. The codeine/acetaminophen group had more patients with 1 or more adverse events.

CONCLUSION

Rofecoxib provided superior analgesic efficacy compared with codeine/acetaminophen with fewer gastrointestinal and nervous system adverse events.

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  • Authors+Show Affiliations

    ,

    Clinical Development, Merck & Co, Inc, West Point, Pennsylvania, USA.

    , ,

    Source

    MeSH

    Acetaminophen
    Acute Disease
    Adolescent
    Adult
    Analgesics, Non-Narcotic
    Analgesics, Opioid
    Analysis of Variance
    Codeine
    Consumer Product Safety
    Cyclooxygenase 2 Inhibitors
    Double-Blind Method
    Drug Combinations
    Facial Pain
    Female
    Humans
    Lactones
    Logistic Models
    Male
    Molar, Third
    Pain, Postoperative
    Sulfones
    Tooth Extraction

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16182156

    Citation

    Chang, David J., et al. "Analgesic Efficacy of Rofecoxib Compared With Codeine/acetaminophen Using a Model of Acute Dental Pain." Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics, vol. 100, no. 4, 2005, pp. e74-80.
    Chang DJ, Bird SR, Bohidar NR, et al. Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100(4):e74-80.
    Chang, D. J., Bird, S. R., Bohidar, N. R., & King, T. (2005). Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics, 100(4), pp. e74-80.
    Chang DJ, et al. Analgesic Efficacy of Rofecoxib Compared With Codeine/acetaminophen Using a Model of Acute Dental Pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100(4):e74-80. PubMed PMID: 16182156.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain. AU - Chang,David J, AU - Bird,Steven R, AU - Bohidar,Norman R, AU - King,Thomas, PY - 2005/01/20/received PY - 2005/04/12/revised PY - 2005/04/25/accepted PY - 2005/9/27/pubmed PY - 2006/2/24/medline PY - 2005/9/27/entrez SP - e74 EP - 80 JF - Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics JO - Oral Surg Oral Med Oral Pathol Oral Radiol Endod VL - 100 IS - 4 N2 - OBJECTIVE: To determine analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with acetaminophen/codeine 600/60 mg, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group study. STUDY DESIGN: Patients (N = 390) experiencing moderate or severe pain postextraction of 2 or more third molars, with at least 1 mandibular impaction, were randomized to placebo (n = 30), rofecoxib (n = 180), or codeine/acetaminophen 60/600 mg (n = 180). Time to confirmed perceptible pain relief, and patient evaluations of pain intensity, pain relief, and global assessments were recorded. RESULTS: For total pain relief over 6 hours (primary end point), rofecoxib was superior to codeine/acetaminophen (15.5 vs 10.7; P < .001). Rofecoxib was statistically significantly superior to codeine/acetaminophen with respect to TOPAR4, patient global assessment, peak pain relief, and duration of analgesic effect. Median onset of analgesia was similar for both drugs. The codeine/acetaminophen group had more patients with 1 or more adverse events. CONCLUSION: Rofecoxib provided superior analgesic efficacy compared with codeine/acetaminophen with fewer gastrointestinal and nervous system adverse events. SN - 1528-395X UR - https://www.unboundmedicine.com/medline/citation/16182156/Analgesic_efficacy_of_rofecoxib_compared_with_codeine/acetaminophen_using_a_model_of_acute_dental_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1079-2104(05)00441-5 DB - PRIME DP - Unbound Medicine ER -