The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.
Delirium is a common postoperative complication occurring in up to 73% of patients sometime during their hospital stay. Elderly patients undergoing major surgical procedures are at highest risk. While many risk factors for delirium are known, the specific pathophysiology of postoperative delirium remains unclear and is likely multifactorial. The most common inciting agents and events include metabolic causes, medications, blood loss, hypoxemia and pain. Pain and its management are intimately related to the likelihood of developing postoperative delirium. As a class, gabapentinoids, such as pregabalin, have proven to reduce postoperative pain and narcotic consumption and therefore may have a role to play in the prevention of postoperative delirium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
Pregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
The Ottawa Hospital
Ottawa, Ontario, Canada
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
Time frame: postoperative day 1, 2, 3
Interference with daily activities using BPI
Time frame: postoperative day 3
Pain at rest using NRS
Time frame: postoperative days 1, 2, 3
Pain with movement of the operative site using NRS
Time frame: postoperative days 1, 2, 3
Narcotic analgesic requirements
Time frame: postoperative days 0, 1, 2, 3
Sedation using RSS
Time frame: postoperative days 1, 2, 3
Narcotic-related adverse effects using ORSDS
Time frame: postoperative days 1, 2, 3
Recovery using the QoR
Time frame: postoperative day 3
Length of stay
Time frame: Discharge day
Medical Outcome Study (MOS) sleep score
Time frame: Postoperative day 3
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