Evaluation of Ketamine and Multi-modal Analgesics

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02815111

Enrollment

Registered

2016-06-28

Start date

2016-07-31

Completion date

2018-07-31

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGKetamine

Receive an analgesic regimen that involves Ketamine infusions

DRUGLidocaine

Receive an analgesic regimen that involves Lidocaine infusions

DRUGAcetaminophen

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

DRUGNeurontin

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026