Pregabalin in the Prevention of Postoperative Delirium and Pain

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Dr. A. Chaput, Ottawa Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT00819988

First received: January 8, 2009

Last updated: January 9, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2009

Last Updated Date

January 9, 2012

Start Date ^ICMJE

May 2009

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) [ Time Frame: postoperative day 1, 2, 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Delirium (CAM-ICU positive) [ Time Frame: postoperative day 1, 2, 3 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00819988 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Interference with daily activities using BPI [ Time Frame: postoperative day 3 ] [ Designated as safety issue: No ]
Pain at rest using NRS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: No ]
Pain with movement of the operative site using NRS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: No ]
Narcotic analgesic requirements [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
Sedation using RSS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: Yes ]
Narcotic-related adverse effects using ORSDS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: Yes ]
Recovery using the QoR [ Time Frame: postoperative day 3 ] [ Designated as safety issue: No ]
Length of stay [ Time Frame: Discharge day ] [ Designated as safety issue: Yes ]
Medical Outcome Study (MOS) sleep score [ Time Frame: Postoperative day 3 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Interference with daily activities using BPI [ Time Frame: postoperative day 3 ] [ Designated as safety issue: No ]
Pain at rest using NRS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: No ]
Pain with movement of the operative site using NRS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: No ]
Narcotic analgesic requirements [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
Sedation using RSS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: Yes ]
Narcotic-related adverse effects using ORSDS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: Yes ]
Recovery using the QoR [ Time Frame: postoperative day 3 ] [ Designated as safety issue: No ]
Length of stay [ Time Frame: Discharge day ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Enrollment ^ICMJE

240

Completion Date

October 2011

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00819988

Other Study ID Numbers ^ICMJE

PSI2008525

Has Data Monitoring Committee

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

Information Provided By

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

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