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The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting

NCT00623285 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-03-16

No results posted yet for this study

Summary

We hypothesize that the perioperative administration of pregabalin will significantly decrease pain scores and post-operative opioid requirements for patients undergoing coronary artery bypass grafting, and reduces the incidence of opioid-induced side effects such as respiratory depression. This may reduce ICU admission and possibly abbreviate length of hospital stay.

Conditions

  • Postoperative Pain.

Interventions

DRUG

Pregabalin

Pregabalin 150mg orally 60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive 150mg twice a day through the first 2 post-operative days for a total of six doses.

DRUG

Placebo/Lactose

Matching Placebo orally,60 minutes pre-operatively. Patients will receive the first dose post-operatively 12 hours after the initial dose was taken (+ 6 hours) given that patient is able to swallow and then they will receive placebo twice a day through the first 2 post-operative days for a total of six doses. If the patient is unable to swallow and NG tube is in place, the medication can be dissolved in water and administered through the NG tube.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Joel A Loieselle, MD · St. Boniface General Hospital and U of M

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00623285 on ClinicalTrials.gov