Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan

Chen, Yeung-Jen; Chiang, Chao-Ching; Huang, Peng‐Ju; Huang, Jason; Karcher, Keith; Li, Honglan

doi:10.1185/03007995.2015.1082992

Cited by 8 publications

(16 citation statements)

References 16 publications

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“…These articles were then fully assessed using the PICO criteria and the Cochrane Bias Assessment Tool. These same seven articles were considered for the qualitative evaluation, and six were considered for the statistical analysis ( Figure 1 and Figure 2 ) [ 6 , 7 , 8 , 9 , 10 , 11 , 12 ].…”

Section: Resultsmentioning

confidence: 99%

“…In addition, various analgesic regimens can be used (e.g., pre-preventive analgesia, a combination of drugs to employ multimodal analgesia, and local analgesia) [ 5 ]. An analgesic monotherapy approach is common, and one of the most widely used opioid drugs in published clinical trials has been tapentadol immediate release (IR) [ 6 , 7 , 8 , 9 , 10 , 11 , 12 ]. However, tapentadol is a relatively new drug and limited scientific evidence of its analgesic efficacy in a bunionectomy can be found in a few individual clinical trials [ 6 , 7 , 8 , 9 , 10 , 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

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Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis

Franco-de la Torre,

Gómez-Sánchez,

Aragon-Martinez

et al. 2023

Pharmaceuticals

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The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of different doses of tapentadol immediate release (IR) and its adverse effects after a bunionectomy. Pubmed, Cochrane, Lilacs, Medline, and Imbiomed were used to identify abstracts of scientific publications related to the keywords of this systematic review (PROSPERO ID CRD42023437295). Moreover, the risk of bias in all included articles was assessed using the Cochrane Collaboration risk of bias tool. Data on the sum of pain intensity, total pain relief, global assessment, and adverse effects were extracted. The statistical method of inverse variance with means difference was used to evaluate the numerical data and the Mantel–Haenszel and Odd Ratio test to analyze the dichotomous data. In addition, the number needed to treat, the number needed to harm, and the 95% confidence intervals were calculated. A qualitative evaluation (n = 2381) was carried out according to the conclusions of the authors. Tapentadol (n = 1772) was more effective in relieving postoperative pain than the placebo (n = 609) after a bunionectomy. In addition, the analgesic efficacy of IR tapentadol (n = 1323) versus the placebo (n = 390) was evaluated in a total of 1713 patients using a global evaluation of the treatments. All three doses of IR tapentadol showed better results compared to the placebo after a bunionectomy. Finally, the adverse effects have a direct relationship with the dose, and the greatest number of adverse effects are most observed with tapentadol IR 100 mg (n = 2381). It is concluded that tapentadol IR (100 mg) leads to the best satisfaction score in this meta-analysis.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis

Franco-de la Torre,

Gómez-Sánchez,

Aragon-Martinez

et al. 2023

Pharmaceuticals

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“…The search for the "ideal opioid", i.e. a drug with sufficient analgesic power and a low rate of side effects, led to the development of new molecules: tapentadol has been recently proposed as an effective and well tolerated pain killer, suitable for use in many orthopaedic situations, including surgical-related settings (Lee et al, 2014;Lockwood & Dickenson, 2019;Chen et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Tapentadol vs oxycodone/naloxone in the management of pain after total hip arthroplasty in the fast track setting: an observational study

et al. 2019

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Background In recent years, joint replacement surgery has gradually progressed towards the fast-track model, and early rehabilitation immediately after surgery is regarded fundamental for optimal recovery of function: the aim of the present study is to describe the efficacy in perioperative management of pain in patients undergoing total hip replacement surgery and treated with tapentadol or oxycodone/naloxone in combination with ketoprofene. Methods Single-center retrospective study on patients with moderate-severe pain, referred to total hip replacement. Patients received either tapentadol (100 mg/twice-daily post-surgery – treatment group) or oxycodone/naloxone (10 mg/5 mg post-surgery – control group) plus ketoprofen 100 mg/ twice daily. Supplemental analgesia (paracetamol 1 g or morphine 0,1 mg/kg sc) was provided if needed. Pain at rest and pain during movement were evaluated on a daily basis for 4 days post-op, after which patients were usually discharged. All adverse events were reported and compared between the two groups. Results 106 patients were analyzed in the tapentadol group and compared to 105 patients treated with oxycodone/naloxone. Both pain intensity at rest and upon movement were significantly lower in the tapentadol group at all follow-up times ( p < 0.001). Throughout T1-T4, supplemental analgesia was needed by significantly less tapentadol patients compared to the control group. Similarly, regarding side effects, a significantly higher occurrence of post-op nausea, vomit, itching and constipation was observed in the control group ( p < 0.001 in all cases). Conclusion Results from the present study support the use of tapentadol in combination with ketoprofen for the management of moderate-severe pain in the setting of major orthopedic surgery, given its effectiveness in reducing pain intensity, and its satisfactory tolerance.

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“…Chen и соавт. [16] была изучена эффективность тапентадола НВ в дозах 50 и 75 мг у больных (n=60), перенесших бунионэктомию. Дизайн исследования и первичная конечная точка (SPID48) были такими же, как и в описанном выше исследовании.…”

Section: клинические исследования эффективности тапентадола нв в послеоперационном периодеunclassified

Tapentadol in acute pain: a review of the results of international studies

Nikoda

2021

Sovremennaâ revmatologiâ

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The treatment of acute pain is a fundamental goal for doctors of various specialties. Tapentadol, which combines the properties of an opioid receptor agonist and a noradrenalin reuptake inhibitor, is one of the most popular analgesics in the world that is effective in severe acute pain. We provide a review of international publications about pharmacological properties, efficacy and safety of tapentadol immediate release (IR) in acute pain. Data from phase II and III of randomized controlled trials (RCTs), in which tapentadol IR (50, 75 and 100 mg) was used for moderate to severe pain in surgical and therapeutic practice is discussed. A number of studies have compared tapentadol with placebo groups and classical opioids (oxycodone, morphine). The results of two meta-analyzes and systematic reviews of efficacy and safety of this analgesic in patients with acute pain are presented.International multicenter RCTs have demonstrated high efficacy of tapentadol IR 50, 75 and 100 mg in patients in the early postoperative period. Comparison with other opioid analgesics showed that tapentadol was superior to placebo and comparable to oxycodone in analgesic effect.It was concluded that tapentadol has a better safety and tolerability profile than classical opioids. The incidence of adverse events on this drug is lower than on oxycodone or morphine.

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Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan

Abstract: Tapentadol IR treatment significantly relieved acute postoperative pain and was well tolerated in a Taiwanese population. ClinicalTrials.gov identifier: NCT01813890.

Cited by 8 publications

References 16 publications

Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis

Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis

Tapentadol vs oxycodone/naloxone in the management of pain after total hip arthroplasty in the fast track setting: an observational study

Tapentadol in acute pain: a review of the results of international studies

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