Pregabalin in the Prevention of Postoperative Delirium and Pain

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NCT00819988

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Study Location
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Delirium, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- aged 60 years and older

- booked for major orthopaedic or vascular procedure

- expected length of stay > 2 days

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Delirium, PainPregabalin in the Prevention of Postoperative Delirium and Pain
NCT00819988
  1. Ottawa, Ontario
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
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, MScThe Ottawa Hospital
Study Director:Homer Yang, MDThe Ottawa Hospital
Study Director:Gregory L Bryson, MD, MScThe Ottawa Hospital
Study Director:Holly Evans, MDThe Ottawa Hospital
Study Director:Paul Beaule, MDThe Ottawa Hospital
Study Director:Prasad Jetty, MDThe Ottawa Hospital
Study Director:Barbara Power, MDThe 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