Pain Clinical Trial
Official title:
A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery
This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain and dry mouth caused by surgery.
PRIMARY OBJECTIVES:
I. To prospectively determine if a longer 4-day course of dexamethasone (or equivalent) for
the management of postoperative pain and dysphagia following transoral robotic surgery (TORS)
is superior to the current standard of a single injection of dexamethasone 10 mg.
SECONDARY OBJECTIVES:
I. Determine the effect of postoperative corticosteroids on postoperative dysphagia following
TORS.
II. Determine the effect of postoperative corticosteroids on length of hospital stay
following TORS.
III. Determine the complications associated with postoperative corticosteroid use after TORS.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dexamethasone intravenously (IV) at the time of surgery and orally
(PO) every 8 hours for up to 4 days following surgery.
ARM II: Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours
for up to 4 days following surgery.
After completion of study treatment, patients are followed up for up to 12 months.
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