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Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Cooper, Stephen A ; Desjardins, Paul J ; Turk, Dennis C ; Dworkin, Robert H ; Katz, Nathaniel P ; Kehlet, Henrik ; Ballantyne, Jane C ; Burke, Laurie B ; Carragee, Eugene ; Cowan, Penney ; Croll, Scott ; Dionne, Raymond A ; Farrar, John T ; Gilron, Ian ; Gordon, Debra B ; Iyengar, Smriti ; Jay, Gary W ; Kalso, Eija A ; Kerns, Robert D ; McDermott, Michael P ; Raja, Srinivasa N ; Rappaport, Bob A ; Rauschkolb, Christine ; Royal, Mike A ; Segerdahl, Märta ; Stauffer, Joseph W ; Todd, Knox H ; Vanhove, Geertrui F ; Wallace, Mark S ; West, Christine ; White, Richard E ; Wu, Christopher

Pain (Amsterdam), 2016-02, Vol.157 (2), p.288-301 [Periódico revisado por pares]

United States

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Título:
Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations
Autor: Cooper, Stephen A ; Desjardins, Paul J ; Turk, Dennis C ; Dworkin, Robert H ; Katz, Nathaniel P ; Kehlet, Henrik ; Ballantyne, Jane C ; Burke, Laurie B ; Carragee, Eugene ; Cowan, Penney ; Croll, Scott ; Dionne, Raymond A ; Farrar, John T ; Gilron, Ian ; Gordon, Debra B ; Iyengar, Smriti ; Jay, Gary W ; Kalso, Eija A ; Kerns, Robert D ; McDermott, Michael P ; Raja, Srinivasa N ; Rappaport, Bob A ; Rauschkolb, Christine ; Royal, Mike A ; Segerdahl, Märta ; Stauffer, Joseph W ; Todd, Knox H ; Vanhove, Geertrui F ; Wallace, Mark S ; West, Christine ; White, Richard E ; Wu, Christopher
Assuntos: Acute Pain - diet therapy ; Analgesics - therapeutic use ; Clinical Trials as Topic - methods ; Clinical Trials as Topic - standards ; Humans ; Medicin och hälsovetenskap ; Pain Measurement - standards ; Research Design - standards
É parte de: Pain (Amsterdam), 2016-02, Vol.157 (2), p.288-301
Descrição: This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.
Editor: United States
Idioma: Inglês

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Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

United States

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