Evaluation of Ketamine and Multi-modal Analgesics

Withdrawn

• Conditions: Pain
• Interventions: Drug: Ketamine; Drug: Lidocaine; Drug: Acetaminophen; Drug: Neurontin

• Registration Number: NCT02815111
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Study Start: 2016-07
• Primary Completion: 2018-01
• Study Completion: 2018-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Ketamine	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.
Study Group	Lidocaine	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.
Study Group	Acetaminophen	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.
Study Group	Neurontin	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.

Primary Outcome Measures

Name	Time	Method
Changes between the two groups assessed by overall ventilator days	Through study completion, an average of one week	Total ventilator days

Secondary Outcome Measures

Name	Time	Method
Changes between the two groups assessed by ICU length of stay	Through study completion, an average of one week	ICU length of stay