hydrocodone and rofecoxib

To compare the efficacy and tolerability of rofecoxib, hydrocodone/acetaminophen 7.5 mg/750 mg (H/A) and placebo in treating pain after arthroscopy of the knee.. A randomized, double-blind, placebo-controlled, single dose study enrolling patients experiencing moderate or severe pain after knee arthroscopy. Patients with moderate-to-severe postoperative pain received either rofecoxib 50 mg (n = 151), H/A (n = 145), or placebo (n = 147). Pain was measured over 24 h. The primary endpoint was total pain relief at 6 h for rofecoxib 50 mg compared with placebo.. H/A (p = 0.003), but not rofecoxib (p = 0.256) was significantly more effective than placebo for total pain relief at 6 h (TOPAR6). Although analgesic onset and peak were significantly better for H/A than for both rofecoxib (p < 0.01, p < 0.05, respectively) and placebo (p < 0.05, p < 0.001, respectively), rofecoxib patients used significantly less rescue analgesia (p < 0.001) over 24 h. Rofecoxib also provided better Brief Pain Inventory Severity (p = 0.008) and Interference Domain (p = 0.045) scores at 24 h compared to placebo and had lower 24-h Pain Severity scores than H/A (p < 0.05). Treatments were generally well tolerated, with no significant difference in the frequency of patient-reported adverse events between groups.. Rofecoxib 50 mg did not provide significantly different pain relief than placebo at 6 h, and the primary endpoint TOPAR was not attained, although it did show several efficacy benefits at 24 h, including a significant opioid-sparing effect. All treatments were well tolerated, with no significant differences observed. The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Analysis of Variance; Arthroscopy; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrocodone; Knee Joint; Lactones; Logistic Models; Male; Pain Measurement; Pain, Postoperative; Sulfones; Treatment Outcome

The search for an effective post-tonsillectomy analgesic has been disappointing. This study tests the hypothesis that rofecoxib improves pain scores in children for 72 hours post-tonsillectomy when compared to hydrocodone with acetaminophen elixir.. Prospective, randomized, double-blind, active comparison of postoperatively administered rofecoxib or hydrocodone with acetaminophen in 60 healthy children scheduled for elective tonsillectomy.. Sixty ASA I and II children scheduled for elective tonsillectomy were enrolled to receive either rofecoxib or hydrocodone with acetaminophen, commencing at discharge from day surgery. Active and passive pain scores and side effects were assessed for 3 days.. Rofecoxib significantly reduced active pain scores at all time intervals after 6 hours following surgery when compared to hydrocodone with acetaminophen without detectable differences in adverse effects. This difference was not apparent in passive pain scores. A review of analgesic strategies is presented. Study results and review of the literature support the development of pediatric formulations of NSAIDs with greater COX-2 selectivity to improve postsurgical pain relief for children.

Topics: Acetaminophen; Adolescent; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Child; Child, Preschool; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Combinations; Elective Surgical Procedures; Follow-Up Studies; Humans; Hydrocodone; Lactones; Pain Measurement; Pain, Postoperative; Prospective Studies; Sulfones; Time Factors; Tonsillectomy; Treatment Outcome

Functional endoscopic sinus surgery (FESS) is less invasive and more tissue sparing than extirpative techniques, with an assumed benefit of diminished postoperative pain. Oral opioids are commonly prescribed after sinus surgery but are associated with adverse effects, including gastrointestinal and neurologic symptoms. Nonopioid analgesics have been suggested to offer similar pain control efficacy with fewer adverse effects.. To investigate postoperative analgesia in FESS, a prospective randomized, double-blinded comparison of hydrocodone/acetaminophen 7.5/750 mg (an opioidderivative) with rofecoxib 50 mg (a cyclooxygenase-2 inhibitor) was performed.. Forty subjects were enrolled, of which 28 successfully completed the study. Subjects recorded peak pain levels and requirement for rescue analgesia on the day of surgery and for 4 days thereafter. On postoperative day 5, subjects completed an exit survey in which adverse effects and overall satisfaction with pain control were recorded.. In this study, there were no statistical differences in peak pain levels between the groups at any point in the postoperative period, regardless of extent of surgery. Adverse effect profiles were also similar for the two groups.. The use of nonopioid analgesics after FESS may provide similar pain control to oral opioids.

Topics: Acetaminophen; Adolescent; Adult; Aged; Aged, 80 and over; Analgesia; Analgesics, Non-Narcotic; Analgesics, Opioid; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Endoscopy; Female; Follow-Up Studies; Humans; Hydrocodone; Lactones; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Paranasal Sinus Diseases; Prospective Studies; Sulfones; Treatment Outcome

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.. 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.. 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.. 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).. 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.

Topics: 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