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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.

Authors+Show Affiliations

Clinical Development, Merck & Co, Inc, West Point, Pennsylvania, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

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 -