title: Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.
abstract: 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.
authors.affiliation: Stephen 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.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Cooper
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Desjardins
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.forename: Henrik
authors.initials: H
authors.lastname: Kehlet
authors.forename: Jane C
authors.initials: JC
authors.lastname: Ballantyne
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.forename: Eugene
authors.initials: E
authors.lastname: Carragee
authors.forename: Penney
authors.initials: P
authors.lastname: Cowan
authors.forename: Scott
authors.initials: S
authors.lastname: Croll
authors.forename: Raymond A
authors.initials: RA
authors.lastname: Dionne
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.forename: Debra B
authors.initials: DB
authors.lastname: Gordon
authors.forename: Smriti
authors.initials: S
authors.lastname: Iyengar
authors.forename: Gary W
authors.initials: GW
authors.lastname: Jay
authors.forename: Eija A
authors.initials: EA
authors.lastname: Kalso
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Srinivasa N
authors.initials: SN
authors.lastname: Raja
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Christine
authors.initials: C
authors.lastname: Rauschkolb
authors.forename: Mike A
authors.initials: MA
authors.lastname: Royal
authors.forename: Märta
authors.initials: M
authors.lastname: Segerdahl
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Stauffer
authors.forename: Knox H
authors.initials: KH
authors.lastname: Todd
authors.forename: Geertrui F
authors.initials: GF
authors.lastname: Vanhove
authors.forename: Mark S
authors.initials: MS
authors.lastname: Wallace
authors.forename: Christine
authors.initials: C
authors.lastname: West
authors.forename: Richard E
authors.initials: RE
authors.lastname: White
authors.forename: Christopher
authors.initials: C
authors.lastname: Wu
mesh_terms: D059787:Acute Pain / Q000178:diet therapy*; D000700:Analgesics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D006801:Humans; D010147:Pain Measurement / Q000592:standards*; D012107:Research Design / Q000592:standards
chemical_list: D000700:Analgesics