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

Stephen A Cooper¹, Paul J Desjardins, Dennis C Turk+29

• ¹Stephen A. Cooper, LLC, Palm Beach Gardens, FL, USA Desjardins Associates, LLC and Department of Oral and Maxillofacial Surgery, Tufts University, Boston, MA, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Departments of Anesthesiology, Neurology, and Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA Analgesic Solutions, Needham, MA, USA Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark Department of Health Services Research, University of Maryland, Baltimore, MD, LORA Group, LLC, Royal Oak, MD, USA Department of Orthopedic Surgery, Stanford University, Palo Alto, CA, USA American Chronic Pain Association, Rocklin, CA, USA Walter Reed Army Medical Center, Washington, DC, USA Departments of Pharmacology, Toxicology and Foundational Sciences, East Carolina University, Greenville, NC, USA Department of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesiology, Queens University, Kingston, Ontario, Canada Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Eli Lilly & Co, Indianapolis, IN, USA Advise Clinical, Raleigh, NC, USA Department of Anaesthesia, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland United States Department of Veterans Affairs, New Haven, CT, USA Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA Analgesic Concepts, LLC, Arlington, VA, USA Johnson & Johnson Pharmaceutical Research and Development, Titusville, NY, USA Sorrento Therapeutics, San Diego, CA, USA Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden JohnsHopkinsUniversity, Baltimore, MD, USA, and Cara Therapeutics, Shelton, CN, USA Department of Emergency Medicine, MD Anderson Cancer Center, University of Texas, Houston, TX, USA NeurogesX, San Carlos, CA, USA Department of Anesthesiology, University of California San Diego, San Diego, CA, USA Pfizer, Inc, Groton, CT, USA Endo Pharmaceuticals, Chadds Ford, PA, USA.