Current methods and challenges for acute pain clinical trials

INTRODUCTION: The clinical setting of acute pain has provided some of the first approaches for the development of analgesic clinical trial methods. OBJECTIVES: This article reviews current methods and challenges and provides recommendations for future design and conduct of clinical trials of interventions to treat acute pain. CONCLUSION: Growing knowledge about important diverse patient factors as well as varying pain responses to different acute pain conditions and surgical procedures has highlighted several emerging needs for acute pain trials. These include development of early-phase trial designs that minimize variability and thereby enhance assay sensitivity, minimization of bias through blinding and randomization to treatment allocation, and measurement of clinically relevant outcomes such as movement-evoked pain. However, further improvements are needed, in particular for the development of trial methods that focus on treating complex patients at high risk of severe acute pain.