Evaluation of Ketamine and Multi-modal Analgesics

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Receive an analgesic regimen that involves Ketamine infusions
  • Lidocaine (DRUG)
    Receive an analgesic regimen that involves Lidocaine infusions
  • Acetaminophen (DRUG)
    May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration
  • Neurontin (DRUG)
    May be given Neurontin by mouth as an approved medication for pain control

Condition or Disease

  • Pain

Phase

Study Design

Study type: OBSERVATIONAL
Status: Withdrawn
Study results: No Results Available
Age: 18 Years to 85 Years
Enrollment: 0 (ACTUAL)
Funded by: Other
Time Perspective: Prospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Jul 01, 2016
Primary Completion: Jan 01, 2018 ESTIMATED
Completion Date: Jul 01, 2018 ESTIMATED
Study First Posted: Jun 28, 2016 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Jul 30, 2019

Sponsors / Collaborators

Lead Sponsor: University of Florida
Lead sponsor is responsible party
Responsible Party: N/A

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.

Participant Groups

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

  • 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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 85
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes
  • Total ventilator days

Secondary Outcomes
  • ICU length of stay

More Details

NCT Number: NCT02815111
Other IDs: IRB201600316
Study URL: https://clinicaltrials.gov/study/NCT02815111
Last updated: Sep 29, 2023