Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial
Autor: | Harold Minkowitz, Hernan Salazar, David Leiman, Daneshvari Solanki, Lucy Lu, Scott Reines, Michael Ryan, Mark Harnett, Neil Singla |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: | |
Zdroj: | Drugs in R&D, Vol 20, Iss 3, Pp 225-236 (2020) |
Druh dokumentu: | article |
ISSN: | 1174-5886 1179-6901 |
DOI: | 10.1007/s40268-020-00309-0 |
Popis: | Abstract Background and Objective Oral tramadol, an atypical opioid approved in the United States (US) since 1995 and a Schedule IV controlled substance, has less abuse liability compared to Schedule II conventional opioids. Intravenous (IV) tramadol is not available in the US, but has the potential to fill a gap between non-opioid medications and conventional opioids for treatment of acute pain. This study evaluates IV tramadol in the management of postoperative pain compared to placebo and standard-of-care active control. Methods A phase 3, multicenter, double-blind, three-arm, randomized, placebo- and active-controlled, multiple-dose, parallel-group study was conducted to evaluate the efficacy and safety of 50 mg IV tramadol versus placebo and 4 mg IV morphine over 48 h in patients with postoperative pain following abdominoplasty surgery. Results IV tramadol was statistically superior (p |
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