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Trial record 1 of 1 for:    NCT00819988
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Pregabalin in the Prevention of Postoperative Delirium and Pain

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ClinicalTrials.gov Identifier: NCT00819988
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : January 10, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. A. Chaput, Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE January 8, 2009
First Posted Date  ICMJE January 9, 2009
Last Update Posted Date January 10, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) [ Time Frame: postoperative day 1, 2, 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Delirium (CAM-ICU positive) [ Time Frame: postoperative day 1, 2, 3 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Delirium
  • Pain
Intervention  ICMJE
  • 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
    Other Name: Lyrica
  • Other: Sugar pill
    Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
Study Arms  ICMJE
  • Placebo Comparator: Sugar pill
    Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
    Intervention: Other: Sugar pill
  • Experimental: Pregabalin
    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
    Intervention: Drug: Pregabalin
Publications *

*   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
 (submitted: January 9, 2012)
240
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
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