A double-blind, placebo-controlled, single-dose parallel study of the analgesic safety and efficacy of oxycodone HCL/ibuprofen 5/400 mg compared to ibuprofen 400 mg alone and oxycodone HCL 5 mg alone in patients with moderate to severe pain following dental surgery
Date
2003
DOI
Authors
Zarringhalam, Nooshin Majd
Version
OA Version
Citation
Abstract
In order to compare the efficacy and safety of a single-dose oral combination of oxycodone and ibuprofen to that of either drug alone and placebo for the treatment of acute postoperative pain, 498 patients were randomized in this double-blind, placebo and active-controlled, multicenter, parallel study. Patients with moderate to severe pain following surgical removal of at least 2 ipsilateral bony impacted third molars received a single dose of oxycodone/ibuprofen 5/400 rng combination or identical doses of either drug alone or placebo. The primary efficacy parameters were Total Pain Relief and Sum of Pain Intensity Difference over 6 hours (TOTPAR 6,SPID 6). Other endpoints included time to onset and a global evaluation score by the patient. Analysis of the data indicated that there was a significantly greater reduction in pain intensity and increased pain relief with oxycodone/ibuprofen treatment compared with ibuprofen alone over the entire 6- hour evaluation period(SPID 6, TOTPAR 6, P[less than]0.05), oxycodone alone (TOTPAR 6 and SPID 6, P[less than]0.001), or placebo (TOTPAR 6 and SPID 6, P[less than]0.001). Oxycodone/ibuprofen had an earlier onset of analgesia compared with ibuprofen(P[less than]0.01) or oxycodone alone (P[less than]0.001). The combination treatment had a 28% faster median time to onset of pain relief than did ibuprofen alone (21.4 vs. 29.7 minutes). Global Evaluation scores for patients receiving the combination treatment were significantly superior to those for patients receiving itouprofen (P[less than]0.01) or oxycodone (P[less than]0.001) alone. The most common treatment-emergent adverse events (TEAEs) were nausea and vomiting. There was no difference in the incidence of TEAEs among the combination, ibuprofen, and placebo groups. Patients receiving oxycodone alone had the highest incidence of TEAEs. It was concluded that oxycodone/ibuprofen combination provides statistically significant and clinically superior analgesia in acute postoperative pain compared with identical doses of each component alone or placebo. The combination drug was also safe and well tolerated.
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Thesis (M.S.D.)--Boston University, Henry M. Goldman School of Dental Medicine, 2003 (Periodontology and Oral Biology).
Includes bibliographical references (leaves 119-122).
Thesis (M.S.D.)--Boston University, Henry M. Goldman School of Dental Medicine, 2003 (Periodontology and Oral Biology).
Includes bibliographical references (leaves 119-122).
License
This work is protected by copyright. Downloading is restricted to the BU community. If you are the author of this work and would like to make it publicly available, please contact open-help@bu.edu.