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Evaluation of Ketamine and Multi-modal Analgesics

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ClinicalTrials.gov Identifier: NCT02815111
Recruitment Status : Withdrawn (Not IRB approved)
First Posted : June 28, 2016
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date June 16, 2016
First Posted Date June 28, 2016
Last Update Posted Date July 31, 2019
Study Start Date July 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2016)
Changes between the two groups assessed by overall ventilator days [ Time Frame: Through study completion, an average of one week ]
Total ventilator days
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2016)
Changes between the two groups assessed by ICU length of stay [ Time Frame: Through study completion, an average of one week ]
ICU length of stay
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Ketamine and Multi-modal Analgesics
Official Title Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing planned surgery for cardiac problems
Condition Pain
Intervention
  • Drug: Ketamine
    Receive an analgesic regimen that involves Ketamine infusions
    Other Name: Ketalar
  • Drug: Lidocaine
    Receive an analgesic regimen that involves Lidocaine infusions
    Other Name: 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 Name: Tylenol
  • Drug: Neurontin
    May be given Neurontin by mouth as an approved medication for pain control
    Other Name: Gabapentin
Study Groups/Cohorts
  • 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.
    Interventions:
    • Drug: Ketamine
    • Drug: Lidocaine
    • Drug: Acetaminophen
    • Drug: Neurontin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: February 20, 2017)
0
Original Estimated Enrollment
 (submitted: June 23, 2016)
200
Estimated Study Completion Date July 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT02815111
Other Study ID Numbers IRB201600316
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: Sean Kiley, M.D. University of Florida
PRS Account University of Florida
Verification Date July 2019