Evaluation of Ketamine and Multi-modal Analgesics

NCT02815111 | Withdrawn

• 1 other identifier: IRB201600316
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Changes between the two groups assessed by overall ventilator days

  Total ventilator days

  Through study completion, an average of one week

Secondary Outcomes (1)

• Changes between the two groups assessed by ICU length of stay

  Through study completion, an average of one week

Study Arms (2)

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; Drug: Lidocaine; Drug: Acetaminophen; Drug: Neurontin

Interventions

Ketamine DRUG

Receive an analgesic regimen that involves Ketamine infusions

Also known as: Ketalar

Study Group

Lidocaine DRUG

Receive an analgesic regimen that involves Lidocaine infusions

Also known as: Lidopen

Study Group

Acetaminophen DRUG

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

Also known as: Tylenol

Study Group

Neurontin DRUG

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

Also known as: Gabapentin

Study Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing planned surgery for cardiac problems

You may qualify if:

• American Society of Anesthesiologists (ASA) status 1-4
• Undergoing planned surgery for cardiac problems
• years of age and not older than 85 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Pain

Interventions

Ketamine; Lidocaine; Acetaminophen; Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sean Kiley, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share