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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Recruitment Status : Withdrawn (Not IRB approved)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 : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

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
Pain Drug: Ketamine Drug: Lidocaine Drug: Acetaminophen Drug: Neurontin

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.

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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 : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Group/Cohort 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 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




Primary Outcome Measures :
  1. Changes between the two groups assessed by overall ventilator days [ Time Frame: 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 [ Time Frame: Through study completion, an average of one week ]
    ICU length of stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing planned surgery for cardiac problems
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815111


Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Sean Kiley, M.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02815111     History of Changes
Other Study ID Numbers: IRB201600316
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lidocaine
Ketamine
Gabapentin
Acetaminophen
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Antipyretics
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Antimanic Agents