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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00819988 |
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Date of registration:
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08/01/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pregabalin in the Prevention of Postoperative Delirium and Pain
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Scientific title:
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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 |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00819988 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Gregory L Bryson, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Prasad Jetty, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Barbara Power, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Paul Beaule, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Alan J Chaput, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Holly Evans, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Name:
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Homer Yang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ottawa Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- aged 60 years and older
- booked for major orthopaedic or vascular procedure
- expected length of stay > 2 days
Exclusion Criteria:
- 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
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Delirium
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Pain
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Intervention(s)
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Drug: Pregabalin
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Other: Sugar pill
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Primary Outcome(s)
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Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
[Time Frame: postoperative day 1, 2, 3]
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Secondary Outcome(s)
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Pain with movement of the operative site using NRS
[Time Frame: postoperative days 1, 2, 3]
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Medical Outcome Study (MOS) sleep score
[Time Frame: Postoperative day 3]
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Narcotic-related adverse effects using ORSDS
[Time Frame: postoperative days 1, 2, 3]
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Narcotic analgesic requirements
[Time Frame: postoperative days 0, 1, 2, 3]
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Sedation using RSS
[Time Frame: postoperative days 1, 2, 3]
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Pain at rest using NRS
[Time Frame: postoperative days 1, 2, 3]
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Recovery using the QoR
[Time Frame: postoperative day 3]
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Length of stay
[Time Frame: Discharge day]
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Interference with daily activities using BPI
[Time Frame: postoperative day 3]
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Secondary ID(s)
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PSI2008525
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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