Pregabalin in the Prevention of Postoperative Delirium and Pain
NCT00819988
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- aged 60 years and older
- booked for major orthopaedic or vascular procedure
- expected length of stay > 2 days
- open AAA repair
- EVAR
- allergy/sensitivity to pregabalin or gabapentin
- use of pregabalin or gabapentin in previous 14 days
- severe liver disease
- severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or
being dialysis-dependent
- seizure disorder
- MMSE < 24/30
- inability to speak English or French
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- Ottawa, Ontario
Descriptive Information | ||||||||||||||||||||||
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Brief Title ICMJE | Pregabalin in the Prevention of Postoperative Delirium and Pain | |||||||||||||||||||||
Official Title ICMJE | 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 | |||||||||||||||||||||
Brief Summary | 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. | |||||||||||||||||||||
Detailed Description | 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 ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention | |||||||||||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||
Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||
Actual Enrollment ICMJE | 240 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE | 140 | |||||||||||||||||||||
Actual Study Completion Date ICMJE | October 2011 | |||||||||||||||||||||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | Canada | |||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT00819988 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | PSI2008525 | |||||||||||||||||||||
Has Data Monitoring Committee | No | |||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||
Responsible Party | Dr. A. Chaput, Ottawa Hospital Research Institute | |||||||||||||||||||||
Study Sponsor ICMJE | Ottawa Hospital Research Institute | |||||||||||||||||||||
Collaborators ICMJE | Pfizer | |||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Ottawa Hospital Research Institute | |||||||||||||||||||||
Verification Date | January 2012 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |