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Sponsors and Collaborators: |
Ottawa Health Research Institute Pfizer |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00819988 |
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.
Condition | Intervention | Phase |
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Delirium Pain |
Drug: Pregabalin Other: Sugar pill |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management |
Estimated Enrollment: | 140 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sugar pill: Placebo Comparator
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
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Other: Sugar pill
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
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Pregabalin: Experimental
Single dose of 75 mg given 30-60 minutes preoperatively, then 50 mg every 8 hours for 3 days postoperatively if creatinine clearance > 60 ml/min OR 25 mg every 8 hours for 3 days postoperatively if creatinine clearance 30-60 ml/min
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Drug: Pregabalin
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
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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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alan J Chaput, MD, MSc | 613-761-4169 | achaput@ottawahospital.on.ca |
Contact: Gregory L Bryson, MD, MSc | 613-761-4169 | glbryson@ottawahospital.on.ca |
Canada, Ontario | |
The Ottawa Hospital | |
Ottawa, Ontario, Canada, K1Y 4E9 |
Principal Investigator: | Alan J Chaput, MD, MSc | The Ottawa Hospital |
Study Director: | Homer Yang, MD | The Ottawa Hospital |
Study Director: | Gregory L Bryson, MD, MSc | The Ottawa Hospital |
Study Director: | Holly Evans, MD | The Ottawa Hospital |
Study Director: | Paul Beaule, MD | The Ottawa Hospital |
Study Director: | Prasad Jetty, MD | The Ottawa Hospital |
Study Director: | Barbara Power, MD | The Ottawa Hospital |
Responsible Party: | Ottawa Health Research Institute ( Alan J. Chaput, Clinical Investigator ) |
Study ID Numbers: | PSI2008525 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819988 History of Changes |
Health Authority: | Canada: Health Canada |
Postoperative Perioperative Orthopedic surgery Vascular surgery Gabapentinoid |
Pregabalin Pain Confusion Cognition Disorders Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations |
Peripheral Nervous System Agents Analgesics Dementia Neurobehavioral Manifestations Anticonvulsants Pain, Postoperative Delirium |
Nervous System Diseases Physiological Effects of Drugs Pregabalin Confusion Pharmacologic Actions Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Sensory System Agents |
Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Neurobehavioral Manifestations Anticonvulsants Delirium |