Evaluation of Ketamine and Multi-modal Analgesics

Study Overview
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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.

Official Title
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Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia

Conditions
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Pain

Intervention / Treatment
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* Drug: Ketamine
* Drug: Lidocaine
* Drug: Acetaminophen
* Drug: Neurontin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Intensivists will proceed with analgesia utilizing conventional opioid based pain order sets. | |
| Study Group<br>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<br>* Receive an analgesic regimen that involves Ketamine infusions<br>* Other names: Ketalar;Drug: Lidocaine<br>* Receive an analgesic regimen that involves Lidocaine infusions<br>* Other names: Lidopen;Drug: Acetaminophen<br>* May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration<br>* Other names: Tylenol;Drug: Neurontin<br>* May be given Neurontin by mouth as an approved medication for pain control<br>* Other names: Gabapentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes between the two groups assessed by overall ventilator days | Total ventilator days | Through study completion, an average of one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes between the two groups assessed by ICU length of stay | ICU length of stay | Through study completion, an average of one week |