For this study we are seeking people who have a bunion they wish to have surgically removed.
Dexmedetomidine is a drug that is commercially available as Precedex™ (dexmedetomidine hydrochloride). Precedex is given intravenously (directly into the vein) as a sedative for either patients during treatment in an intensive care unit (ICU) setting or for patients before and/or during surgical and other procedures for up to 24 hours as a continuous infusion.
The sponsor of this study is developing an investigational transdermal drug delivery system that is designed to provide extended release of dexmedetomidine over a 3-day period to manage perioperative pain. The perioperative period is before during, and after surgery. The DMTS is a new formulation of dexmedetomidine in the form of a patch, and is intended to be an alternative to the intravenous (IV) delivery of dexmedetomidine. The drug will be delivered through the skin via the patch.
Dexmedetomidine can be used for sedation and analgesia and for managing pain during the perioperative period. Management of acute pain in the perioperative setting is intended to reduce or eliminate postoperative pain. Acute pain is defined as the pain experienced by a patient after a procedure (such as a surgical procedure). The pain may be the result of trauma from the procedure or procedure-related complications. In the perioperative setting, which could span a period of several days, a transdermal delivery of dexmedetomidine would provide a convenient drug delivery option.
This research project is testing a new treatment for acute moderate to severe pain following unilateral bunionectomy. The new treatment is called the Dexmedetomidine Transdermal System (DMTS).