Status:
COMPLETED
Pregabalin in the Prevention of Postoperative Delirium and Pain
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Pfizer
Conditions:
Delirium
Pain
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 post...
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...
Eligibility Criteria
Inclusion
- aged 60 years and older
- booked for major orthopaedic or vascular procedure
- expected length of stay \> 2 days
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00819988
Start Date
May 1 2009
End Date
October 1 2011
Last Update
January 10 2012
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9