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Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial.

Abstract

BACKGROUND

In recent studies of acute pain and primary dysmenorrhea, rofecoxib, a nonsteroidal anti-inflammatory drug that selectively targets the cyclooxygenase-2 enzyme, was found to be similar in efficacy to ibuprofen and naproxen sodium.

OBJECTIVE

The purpose of this study was to determine the analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with the combination of codeine 60 mg/acetaminophen 600 mg in a model of postsurgical dental pain.

METHODS

In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate or severe pain after the surgical extraction of > or = 2 third molars, at least 1 of which was a mandibular impaction, were randomized to receive placebo, rofecoxib 50 mg, or codeine 60 mg/acetaminophen 600 mg. Patient evaluations of pain intensity, pain relief, and global assessments were recorded throughout the 24-hour period after dosing. The 2-stopwatch method was used to determine time to confirmed perceptible pain relief. The primary end point assessing overall analgesic effect was total pain relief over 6 hours (TOPAR6). Secondary end points were patient global assessment of response to therapy (PGART) at 6 hours, onset of analgesia, peak analgesic effect, and duration of analgesia.

RESULTS

A total of 393 patients were enrolled; 182 received rofecoxib, 180 received codeine/acetaminophen, and 31 received placebo. The overall analgesic effect of rofecoxib 50 mg was greater than that of codeine 60 mg/acetaminophen 600 mg for TOPAR6 (12.4 vs 7.0; P < 0.001) and PGART at 6 hours (P < 0.001). The onset of analgesic effect was similar for rofecoxib and codeine/acetaminophen. Peak analgesic effect as measured by peak pain relief scores during the first 6 hours was significantly greater in the rofecoxib group compared with the codeine/acetaminophen group (P < 0.001), as was the duration of analgesic effect measured by the time to rescue analgesia (9.6 hours vs 2.3 hours, P < 0.001). Adverse events were reported in 33.0%, 46.1%, and 32.3% of patients treated with rofecoxib, codeine/acetaminophen, and placebo, respectively. The most common adverse events were nausea (6.0%, 25.0%, and 9.7%, respectively) and vomiting (3.8%, 18.3%, and 6.5%, respectively). Significantly more patients in the codeine/acetaminophen group than in the rofecoxib group experienced adverse events overall (P < 0.050) and nausea in particular (P < 0.001).

CONCLUSION

In this study of moderate to severe postoperative dental pain, the analgesic efficacy of rofecoxib 50 mg was greater than that of codeine/acetaminophen, with a lower incidence of adverse events and nausea.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Merck & Co, Inc, West Point, Pennsylvania 19486-0004, USA. david_chang@merck.com

    , , , ,

    Source

    Clinical therapeutics 23:9 2001 Sep pg 1446-55

    MeSH

    Acetaminophen
    Adolescent
    Adult
    Analgesics, Non-Narcotic
    Analgesics, Opioid
    Codeine
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Humans
    Hydrocodone
    Lactones
    Male
    Pain Measurement
    Pain, Postoperative
    Sulfones
    Time Factors
    Tooth Extraction
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    11589259

    Citation

    Chang, D J., et al. "Rofecoxib Versus Codeine/acetaminophen in Postoperative Dental Pain: a Double-blind, Randomized, Placebo- and Active Comparator-controlled Clinical Trial." Clinical Therapeutics, vol. 23, no. 9, 2001, pp. 1446-55.
    Chang DJ, Fricke JR, Bird SR, et al. Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial. Clin Ther. 2001;23(9):1446-55.
    Chang, D. J., Fricke, J. R., Bird, S. R., Bohidar, N. R., Dobbins, T. W., & Geba, G. P. (2001). Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial. Clinical Therapeutics, 23(9), pp. 1446-55.
    Chang DJ, et al. Rofecoxib Versus Codeine/acetaminophen in Postoperative Dental Pain: a Double-blind, Randomized, Placebo- and Active Comparator-controlled Clinical Trial. Clin Ther. 2001;23(9):1446-55. PubMed PMID: 11589259.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial. AU - Chang,D J, AU - Fricke,J R, AU - Bird,S R, AU - Bohidar,N R, AU - Dobbins,T W, AU - Geba,G P, PY - 2001/10/9/pubmed PY - 2002/1/24/medline PY - 2001/10/9/entrez SP - 1446 EP - 55 JF - Clinical therapeutics JO - Clin Ther VL - 23 IS - 9 N2 - BACKGROUND: In recent studies of acute pain and primary dysmenorrhea, rofecoxib, a nonsteroidal anti-inflammatory drug that selectively targets the cyclooxygenase-2 enzyme, was found to be similar in efficacy to ibuprofen and naproxen sodium. OBJECTIVE: The purpose of this study was to determine the analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with the combination of codeine 60 mg/acetaminophen 600 mg in a model of postsurgical dental pain. METHODS: In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate or severe pain after the surgical extraction of > or = 2 third molars, at least 1 of which was a mandibular impaction, were randomized to receive placebo, rofecoxib 50 mg, or codeine 60 mg/acetaminophen 600 mg. Patient evaluations of pain intensity, pain relief, and global assessments were recorded throughout the 24-hour period after dosing. The 2-stopwatch method was used to determine time to confirmed perceptible pain relief. The primary end point assessing overall analgesic effect was total pain relief over 6 hours (TOPAR6). Secondary end points were patient global assessment of response to therapy (PGART) at 6 hours, onset of analgesia, peak analgesic effect, and duration of analgesia. RESULTS: A total of 393 patients were enrolled; 182 received rofecoxib, 180 received codeine/acetaminophen, and 31 received placebo. The overall analgesic effect of rofecoxib 50 mg was greater than that of codeine 60 mg/acetaminophen 600 mg for TOPAR6 (12.4 vs 7.0; P < 0.001) and PGART at 6 hours (P < 0.001). The onset of analgesic effect was similar for rofecoxib and codeine/acetaminophen. Peak analgesic effect as measured by peak pain relief scores during the first 6 hours was significantly greater in the rofecoxib group compared with the codeine/acetaminophen group (P < 0.001), as was the duration of analgesic effect measured by the time to rescue analgesia (9.6 hours vs 2.3 hours, P < 0.001). Adverse events were reported in 33.0%, 46.1%, and 32.3% of patients treated with rofecoxib, codeine/acetaminophen, and placebo, respectively. The most common adverse events were nausea (6.0%, 25.0%, and 9.7%, respectively) and vomiting (3.8%, 18.3%, and 6.5%, respectively). Significantly more patients in the codeine/acetaminophen group than in the rofecoxib group experienced adverse events overall (P < 0.050) and nausea in particular (P < 0.001). CONCLUSION: In this study of moderate to severe postoperative dental pain, the analgesic efficacy of rofecoxib 50 mg was greater than that of codeine/acetaminophen, with a lower incidence of adverse events and nausea. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/11589259/Rofecoxib_versus_codeine/acetaminophen_in_postoperative_dental_pain:_a_double_blind_randomized_placebo__and_active_comparator_controlled_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(01)80119-3 DB - PRIME DP - Unbound Medicine ER -