Comparison of rofecoxib and a multidose oxycodone/acetaminophen regimen for the treatment of acute pain following oral surgery: a randomized controlled trial
| Autor: | Richard A. Petruschke, Steven R. Bird, David J. Chang, Erluo Chen, Peter McL. Black, Gregory P. Geba, Paul J. Desjardins |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Pain Placebo law.invention Oxycodone/Acetaminophen Placebos Lactones Double-Blind Method Randomized controlled trial law medicine Clinical endpoint Humans Sulfones Rofecoxib Acetaminophen Analgesics Dose-Response Relationship Drug business.industry General Medicine Surgery Oral Surgery Regimen Treatment Outcome Anesthesia Acute Disease Drug Therapy Combination Female business Oxycodone medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 20:939-949 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1185/030079904125003863 |
| Popis: | To compare the efficacy of a single dose of rofecoxib 50 mg with a single dose of oxycodone/acetaminophen 10/650 mg over 6 h as well as with a multidose regimen of oxycodone/acetaminophen 10/650 mg followed by oxycodone/acetaminophen 5/325 mg over 24 h.In this double-blind, randomized, two-phase study, patients with moderate to severe pain after surgical extraction ofor= 2 third molars, including one mandibular impaction, were treated with rofecoxib 50 mg, oxycodone/acetaminophen 10/650 mg (singledose phase) followed by 5/325 mg every 6h as needed (multidose phase), or placebo. Patients rated their pain relief and intensity at 18 time points over 24 h. Efficacy was measured over 6 and 24 h by total pain relief (TOPAR), sum of pain intensity difference (SPID), and patient global assessment of response to therapy (PGART). Primary endpoint for the single dose comparison was TOPAR over 6 h; SPID was the key 24-h endpoint. Onset of analgesic effect, peak analgesic single dose of oxycodone/acetaminophen. effect, and duration of analgesic effect were also evaluated. Adverse experiences were recorded.271 patients were randomized to treatment with rofecoxib (n = 121), oxycodone/acetaminophen (n = 120), or placebo (n = 30). For the single dose comparison, rofecoxib-treated patients achieved pain relief at least as effective as oxycodone/acetaminophentreated patients as assessed by TOPAR6 (12.9 vs 11.3, 95% CI on difference = [-0.1, 3.2], p = 0.059). Patients also rated a single dose of rofecoxib as at least as effective as multidose oxycodone/acetaminophen over 24 h on SPID24 (21.9 vs 18.1, 95% CI on difference = [-1.0, 8.8], p = 0.122). Patients treated with oxycodone/ acetaminophen had a shorter time to onset of analgesia than patients treated with rofecoxib (24 vs 35 min, p0.05). Patients in the active treatment groups achieved similar peak effects during the single-dose phase. Individuals treated with rofecoxib demonstrated a longer duration of analgesic effect than those treated with a Patients on active treatment demonstrated better efficacy than patients on placebo on these prespecified endpoints (p0.001 for both comparisons). Fewer rofecoxib than oxycodone/acetaminophen patients experienced adverse events (47.9 vs 75.8%, p0.001), including nausea (19.0 vs 42.5%, p0.001), vomiting (9.9 vs 24.2%, p0.01), and dizziness (7.4 vs 31.7%, p0.001).Patients treated with a single dose of rofecoxib 50 mg achieved an overall analgesic effect at least as effective as patients treated with a single-dose of oxycodone/acetaminophen 10/650 mg over 6 h and multidose oxycodone/acetaminophen over 24 h, with fewer adverse experiences of nausea (p0.001), vomiting (p0.01), and dizziness (p0.001). |
| Databáze: | OpenAIRE |
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