Evaluation of Ketamine and Multi-modal Analgesics | NCT02815111

Studies
Evaluation of Ketamine and Multi-modal Analgesics

NCT02815111

Sponsor

University of Florida

Status

Withdrawn

Last Update Posted

Jul 31, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pain

Interventions

Ketamine
Lidocaine
Acetaminophen
Neurontin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not IRB approved

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jan 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jun 16, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2019

Last Update Posted Date

Jul 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug	Receive an analgesic regimen that involves Ketamine infusions	Study Group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing planned surgery for cardiac problems

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Sean Kiley, M.D.	University of Florida	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine
D008012	Lidocaine
D000082	Acetaminophen
D000077206	Gabapentin

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided