Evaluation of Ketamine and Multi-modal Analgesics

NCT ID: NCT02815111

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

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

No interventions assigned to this group

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.

Ketamine

Intervention Type DRUG

Receive an analgesic regimen that involves Ketamine infusions

Lidocaine

Intervention Type DRUG

Receive an analgesic regimen that involves Lidocaine infusions

Acetaminophen

Intervention Type DRUG

May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration

Neurontin

Intervention Type DRUG

May be given Neurontin by mouth as an approved medication for pain control

Interventions

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Ketamine

Receive an analgesic regimen that involves Ketamine infusions

Intervention Type DRUG

Lidocaine

Receive an analgesic regimen that involves Lidocaine infusions

Intervention Type DRUG

Acetaminophen

May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration

Intervention Type DRUG

Neurontin

May be given Neurontin by mouth as an approved medication for pain control

Intervention Type DRUG

Other Intervention Names

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Ketalar Lidopen Tylenol Gabapentin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Kiley, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

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IRB201600316

Identifier Type: -

Identifier Source: org_study_id

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