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Evaluation of Ketamine and Multi-modal Analgesics

Sponsor
University of Florida (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02815111
Collaborator
(none)
0
Enrollment
24
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The investigators plan to study an analgesic regimen of Ketamine and Lidocaine as infusions with Neurontin and acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. The investigators expect that pain scores will be either unchanged or better than historic controls. In addition, the investigators expect that ventilator days and ICU stay will be improved due to reduced incidence of delirium and bowel dysfunction.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Control Group

Intensivists will proceed with analgesia utilizing conventional opioid based pain order sets.
Study Group

The investigators plan to study an analgesic regimen of Ketamine and lidocaine as infusions with Neurontin and Acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay.

Drug: Ketamine
Receive an analgesic regimen that involves Ketamine infusions
Other Names:
  • Ketalar

    • Drug: Lidocaine
    Receive an analgesic regimen that involves Lidocaine infusions
    Other Names:
  • Lidopen

    • Drug: Acetaminophen
    May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration
    Other Names:
  • Tylenol

    • Drug: Neurontin
    May be given Neurontin by mouth as an approved medication for pain control
    Other Names:
  • Gabapentin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes between the two groups assessed by overall ventilator days [Through study completion, an average of one week]

      Total ventilator days

    Secondary Outcome Measures

    1. Changes between the two groups assessed by ICU length of stay [Through study completion, an average of one week]

      ICU length of stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • American Society of Anesthesiologists (ASA) status 1-4

    • Undergoing planned surgery for cardiac problems

    • 18 years of age and not older than 85 years of age

    Exclusion Criteria:

    • Severe liver disease (alanine aminotransferase (ALT) , aspartate aminotransferase (AST), or bilirubin > 2.5 times Upper Limit of Normal)

    • Pregnancy or currently breastfeeding

    • History of schizophrenia or other hallucinatory psychiatric disorder

    • History of chronic or pre-existing pain disorder

    • History of heart block

    • Severe renal impairment Creatinine Clearance (CrCl)<30 milliliter(mL)/min

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Sean Kiley, M.D., University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02815111
    Other Study ID Numbers:
    • IRB201600316
    First Posted:
    Jun 28, 2016
    Last Update Posted:
    Jul 31, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Acetaminophen
    Lidocaine
    Ketamine
    Gabapentin

    Study Results

    No Results Posted as of Jul 31, 2019