Single dose and multidose analgesic study of ibuprofen and meclofenamate sodium after third molar surgery

Hersh, Elliot V.; Cooper, Stephen A.; Betts, Norman J.; Wedell, David; MacAfee, Kenneth; Quinn, Peter D.; Lamp, Claudia; Gaston, Gerald W.; Bergman, Stewart A.; Henry, Eleanor

doi:10.1016/0030-4220(93)90034-2

Cited by 54 publications

(30 citation statements)

References 11 publications

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“…This may be due in part to the normal course of healing; pain is naturally reduced as the body mends itself following surgery, and pain control may become less distinguishable between patients in the placebo group and those taking lower doses of active treatment. Similar results have been reported in a multi-dose study of ibuprofen (200 and 400 mg) and meclofenamate sodium (50 and 100 mg) 23 . This study demonstrated that while higher doses of these analgesics were more effective in the first few hours following third molar extraction, all active treatment groups seemed to provide similar relief as the study progressed.…”

Section: Discussionsupporting

confidence: 87%

The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery

Stegmann

Weber

Steup

et al. 2008

Current Medical Research and Opinion

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C o p y r i g h t I n f o r m a U K L i m i t e d 2 0 0 8 N o t f o r S a l e o r C o m e r c i a l D i s t r i b u t i o n U n a u t h o r i z e d u s e p r o h i b i t e d . A u t h o r i s e d u s e r s c a n d o w n l o a d , A B S T R A C TObjective: Tapentadol is a new, centrally acting analgesic with two mechanisms of action, combining m-opioid agonism and norepinephrine reuptake inhibition in a single molecule. This study assessed tapentadol immediate release (IR) in patients with postsurgical orthopedic pain.Methods: This randomized, double-blind, phase II study involved patients with moderate-to-severe pain after bunionectomy surgery (first metatarsal with osteotomy). Patients (N ¼ 269) were randomly assigned to receive tapentadol IR 50 or 100 mg, oxycodone HCl IR 10 mg, or placebo; the study drug was taken every 4-6 h, over a 72-h period starting 1 day after surgery (Evaluation Day 2). The primary endpoint was the sum of pain intensity over 24 h (SPI-24) on the second day after randomization (Evaluation Day 3). Potential limitations of this study included the use of rescue medication and the fact that it was not powered to statistically compare between-group differences in tolerability measures. Results: Mean (standard deviation [SD]) SPI-24 values on Evaluation Day 3 were significantly lower for tapentadol IR (50 mg: 33.6 [19.7], p ¼ 0.0133; 100 mg: 29.2 [15.2], p ¼ 0.0001) and oxycodone HCl IR 10 mg (35.7 [17.2]; nominal p ¼ 0.0365) compared with placebo (41.9 [17.7]). The most common treatment-emergent adverse events for all treatment groups were characteristic of drugs with m-opioid agonist activity. While providing similar analgesic efficacy, tapentadol IR 50 mg was associated with lower rates of nausea (46.3% vs. 71.6% for oxycodone HCl IR 10 mg), dizziness (32.8% vs. 56.7%), vomiting (16.4% vs. 38.8%), and constipation (6.0% vs. 17.9%), and a similar rate of somnolence (28.4% vs. 26.9%) compared with oxycodone HCl IR 10 mg.Conclusions: Tapentadol IR 50 and 100 mg and oxycodone HCl IR 10 mg were effective in this study for the relief of acute postoperative pain following bunionectomy. The study results suggest improved gastrointestinal tolerability of tapentadol IR 50 mg compared with oxycodone at a dose showing comparable efficacy.

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Section: Discussionsupporting

confidence: 87%

The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery

Stegmann

Weber

Steup

et al. 2008

Current Medical Research and Opinion

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show abstract

“…A lack of significant differences in the effects of 200 and 400 mg of ibuprofen have also been reported in a study enrolling 161 patients undergoing surgical removal of lower bony impacted third molars . Two other single‐dose, placebo‐controlled, double‐blind, randomized, parallel‐group clinical trials enrolling 120 and 100 patients whose third molars were extracted reported no significant differences between 200 and 400 mg in terms of TOTPAR, onset of analgesic effect and SPID.…”

Section: Discussionmentioning

confidence: 84%

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

Cristofoletti

Dressman

2014

Journal of Pharmaceutical Sciences

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“…Also, the method used by ROWE et al 15 , HERSH et al 11 and DANIELS et al 7 , which included the baseline measurement of pain scores (without medication), seems to be adequate for this investigation. However, we decided not to use these methods due to ethic matters.…”

Section: Discussionmentioning

confidence: 97%

“…Results of clinical trials reported in the literature about pain after removal of third molars compare the analgesic effect of NSAID with placebos 13,15 or other drugs 1,6,7,11,17 , or test different regimens 7,11,15 only before or after the surgery.…”

Section: Discussionmentioning

confidence: 99%

Analgesic efficacy of aceclofenac after surgical extraction of impacted lower third molars

Lima

Fontanella

2006

International Journal of Oral and Maxillofacial Surgery

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Single dose and multidose analgesic study of ibuprofen and meclofenamate sodium after third molar surgery

Cited by 54 publications

References 11 publications

The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery

The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

Analgesic efficacy of aceclofenac after surgical extraction of impacted lower third molars

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