search
Back to results

Ketamine vs Lidocaine in Traumatic Rib Fractures

Primary Purpose

Rib Fractures, Rib Fracture Multiple, Rib Trauma

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Lidocaine
Sponsored by
Brittany Hoyte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring Lidocaine, Ketamine, Rib Fracture, Traumatic Rib Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults ≥ 18 years old
  2. ≥ 3 traumatic blunt rib fractures
  3. Enrollment within 16 hours of being admitted to the hospital
  4. Patients whom in the investigator's clinical judgement, would require escalated pain control regiments in the future and would potentially benefit from participation in this study in terms of pain control.

Exclusion Criteria:

  1. Patients receiving any regional/neuraxial anesthetic techniques or ketamine infusion before randomization
  2. Adults with diminished decision-making capacity
  3. Adults of limited English proficiency/non-English speakers
  4. Prisoners
  5. Pregnant or breastfeeding women
  6. Patient admission weight greater than 120 kg
  7. Patients with any of the following medical history:

    1. Active delirium (as defined by Confusion Assessment Method)
    2. Dementia
    3. Psychosis
    4. Glaucoma
    5. Heart block (except with patients with a functioning artificial pacemaker)
    6. Congestive heart failure (ejection fraction <20% recorded in last year)
    7. Adams-Stokes syndrome
    8. Wolff-Parkinson-White Syndrome
  8. Patient is unable to communicate with staff for pain assessments at time of enrollment
  9. Most recent documented Glasgow Coma Score <15 at the time of study enrollment
  10. Severe bradycardia (heart rate <50 bpm based on last vital sign recorded at time of study enrollment)
  11. Sustained hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg for at least 3 sets of vital signs in a row prior to study enrollment)
  12. Any seizure suspected or identified during hospital admission
  13. Patient with active acute coronary syndrome obtained from admission problem list
  14. Patients with known hepatic disease or acute liver failure

    a. Acute liver failure on admission defined as either: i. International normalized ratio > 1.5, without being on home anticoagulation ii. Aspartate aminotransferase or Alanine aminotransferase greater than 120 IU/L (3 times upper limit of normal) b. Known hepatic disease defined as past medical history of Child Turcotte Pugh (Child's) score C

  15. Patients with a history of end-stage renal disease or admission creatinine clearance (CrCl) ≤30 ml/min

    a. CrCl will be based on Cockcroft-Gault equation from admission labs

  16. Use of antiarrhythmic medication therapy prior or during admission

    a. Amiodarone, sotalol, dofetilide, dronedarone, mexilitine

  17. Patients with a known allergy/sensitivity to lidocaine or ketamine, amide anesthetics, or components of the solution
  18. Patients who, in the investigator's opinion, should not be included in this study.

Sites / Locations

  • Spectrum Health HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketamine

Lidocaine

Arm Description

Infusion initiation: 0.1 mg/kg/hr Max: 0.3 mg/kg/hr Recommended titration: 0.1 mg/kg/hr* as needed every 4 hours based on pain scores ≥5 and physician order Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.

Infusion initiation: 1 mg/kg/hr Max: 2 mg/kg/hr Recommended titration:0.25 mg/kg/hr* as needed every 4 hours based on pain scores ≥5 and physician order Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.

Outcomes

Primary Outcome Measures

Oral Morphine Equivalent - Opioid Usage
Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.

Secondary Outcome Measures

Visual Analogue Numeric Pain Score
Visual Analogue Numeric Pain Score are recorded as a scale of 1-10, with 0 being no pain and 10 as worst imaginable pain. Patient will be asked their pain score every 6 hours.
Oral Morphine Equivalent - Opioid Usage
Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.
Respiratory Failure
Respiratory failure was defined by need for mechanical intubation
Use of Regional/Neuraxial anesthesia
Measure of regional/neuraxial anesthesia placement rates. Patient would need to be taken off study medication if decision made to place regional/neuraxial anesthetic.
Hospital Length of Stay
Total hospital length of stay up to 365 days
Intensive Care Unit Length of stay
Total intensive care unit length of stay up to 365 days
Incentive Spirometry
Measure of percent improvement in incentive spirometry level from baseline (before infusion). Incentive spirometry levels range from 0-4,000 mL.
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
In-Hospital mortality
Patient's death will be recorded if it occurs before discharge

Full Information

First Posted
February 22, 2021
Last Updated
September 8, 2023
Sponsor
Brittany Hoyte
search

1. Study Identification

Unique Protocol Identification Number
NCT04781673
Brief Title
Ketamine vs Lidocaine in Traumatic Rib Fractures
Official Title
A Prospective, Randomized, Single-Blinded Trial of Ketamine Versus Lidocaine Infusions for Multimodal Pain Management in Traumatic Rib Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brittany Hoyte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rib fractures continue to be a common occurrence in trauma patients of all ages. Traumatic rib fractures can cause severe pain in patients and lead to shallow breathing and further complications such as the need for mechanical ventilation, hospital or ventilator associated pneumonia, atelectasis, and acute respiratory distress syndrome. Effective multimodal pain management is needed to optimize a patient's respiratory status and can also play a role in early mobility, less pulmonary complications, shorter ICU and hospital length of stay, and decreased mortality. Current multimodal pain management options include opioids, muscle relaxants, gabapentin, acetaminophen, nonsteroidal anti-inflammatory drugs, and various regional/neuraxial anesthesia techniques. Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective, with the benefit of minimizing the use of opioids. However, there have been very few studies that have used ketamine or lidocaine infusions for pain control specifically in patients with traumatic rib fractures. Therefore, the purpose of this study is to evaluate ketamine versus lidocaine infusions as an adjunctive therapy to reduce opioid consumption in the first 72 hours in patients with multiple traumatic rib fractures.
Detailed Description
Effective pain control plays a key role is optimizing a patient's respiratory status after suffering multiple rib fractures. Using multimodal pain management techniques and optimizing a patient's pain control regimen helps to minimize the complications associated with rib fractures, such as pneumonia and the need for mechanical ventilation. The benefit of using opioid-sparing options such as ketamine or lidocaine infusions would be to avoid the side effects associated with opioids, which include delirium, constipation, and depressed respiratory drive. Ketamine and lidocaine infusions are both medications that have been used in numerous studies to effectively treat post-operative pain. Low dose ketamine infusions have also recently been shown to be a safe and effective adjunct option to help reduce pain scores and decrease opioid use in patients with traumatic rib fractures. Currently there is no published studies to assess lidocaine's effectiveness to reduce pain scores and opioid use in traumatic rib fracture patients. There is also only one study to date that has directly compared ketamine to lidocaine infusions for pain control. This study occurred in 60 patients undergoing elective nephrectomy and evaluated three 24-hour infusion groups: ketamine, lidocaine, or placebo. The primary outcome showed that both ketamine and lidocaine infusions significantly reduced 24-hour OME compared to placebo (33% ketamine, 42% lidocaine) and decreased overall pain scores. This trial is a single center, prospective, randomized trial of adult patients with ≥ 3 traumatic rib fractures admitted to a Level 1 trauma center at Spectrum Health Butterworth Hospital. As part of the current rib fracture protocol all patients will receive the standard multimodal pain regimen at the investigator's institution, including acetaminophen, NSAIDS, muscle relaxants and gabapentin. Currently ketamine infusions and regional/neuraxial anesthesia techniques are added if the standard multimodal pain regimen is insufficient. Lidocaine infusions have also been used at the institution for post-surgical pain control to minimize opioid use. The objective of the study will be to compare ketamine versus lidocaine infusions on the effectiveness to optimize pain control as well as minimize the use of opioids in patients with traumatic rib fractures. If consent is obtained the patient will be randomized 1:1 to receive either a ketamine or lidocaine infusion for pain control, along with standard of care, using a pre-designed randomization schedule. Patients must be enrolled within 16 hours of hospital admission and are expected to remain on the infusion for a minimum of 24 hours. The duration, titration, and stopping of study drug will be dependent on the progress of the patient's overall pain status and provider decision, with data being included for the study medication for up to 72 hours. If patients require surgery at any time the study medication will not be held unless signs of adverse events occur. Patients who are unable to remain on the study infusion or have a regional/neuraxial anesthetic placed before the 24-hour mark (decided based on the Trauma and Surgical Intensive Care Unit services) will be considered a screen fail and no data will be contributed to the study, however, the screen fail will be documented. If a patient is unable to remain on infusion or has a regional/neuraxial anesthetic placed ≥ 24 hours, their data will be included up until that point and analyzed. Adverse event and serious adverse events will be monitored throughout the entire study period, with continuous cardiac telemetry being required in both study groups and daily lidocaine levels drawn in the lidocaine group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Rib Fracture Multiple, Rib Trauma
Keywords
Lidocaine, Ketamine, Rib Fracture, Traumatic Rib Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Trial, Single-blinded
Masking
Participant
Masking Description
Medication infusion and medication IV bag will be covered with brown protect from light bag
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Infusion initiation: 0.1 mg/kg/hr Max: 0.3 mg/kg/hr Recommended titration: 0.1 mg/kg/hr* as needed every 4 hours based on pain scores ≥5 and physician order Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Infusion initiation: 1 mg/kg/hr Max: 2 mg/kg/hr Recommended titration:0.25 mg/kg/hr* as needed every 4 hours based on pain scores ≥5 and physician order Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Will receive titratable infusion.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
Will receive titratable infusion, will have daily lidocaine level labs drawn daily.
Primary Outcome Measure Information:
Title
Oral Morphine Equivalent - Opioid Usage
Description
Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.
Time Frame
0-24 hours post infusion
Secondary Outcome Measure Information:
Title
Visual Analogue Numeric Pain Score
Description
Visual Analogue Numeric Pain Score are recorded as a scale of 1-10, with 0 being no pain and 10 as worst imaginable pain. Patient will be asked their pain score every 6 hours.
Time Frame
0-24; 24-48; 48-72 hours post infusion
Title
Oral Morphine Equivalent - Opioid Usage
Description
Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.
Time Frame
24-48; 48-72 hours post infusion
Title
Respiratory Failure
Description
Respiratory failure was defined by need for mechanical intubation
Time Frame
0-30 days post-infusion
Title
Use of Regional/Neuraxial anesthesia
Description
Measure of regional/neuraxial anesthesia placement rates. Patient would need to be taken off study medication if decision made to place regional/neuraxial anesthetic.
Time Frame
0-30 days post infusion
Title
Hospital Length of Stay
Description
Total hospital length of stay up to 365 days
Time Frame
Will capture retrospectively after patient's medical discharge
Title
Intensive Care Unit Length of stay
Description
Total intensive care unit length of stay up to 365 days
Time Frame
Will capture retrospectively after patient's medical discharge
Title
Incentive Spirometry
Description
Measure of percent improvement in incentive spirometry level from baseline (before infusion). Incentive spirometry levels range from 0-4,000 mL.
Time Frame
0-24; 24-48; 48-72 hours post infusion
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
0-72 hours post infusion
Title
In-Hospital mortality
Description
Patient's death will be recorded if it occurs before discharge
Time Frame
Will capture retrospectively after patient's medical discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ≥ 18 years old ≥ 3 traumatic blunt rib fractures Enrollment within 16 hours of being admitted to the hospital Patients whom in the investigator's clinical judgement, would require escalated pain control regiments in the future and would potentially benefit from participation in this study in terms of pain control. Exclusion Criteria: Patients receiving any regional/neuraxial anesthetic techniques or ketamine infusion before randomization Adults with diminished decision-making capacity Adults of limited English proficiency/non-English speakers Prisoners Pregnant or breastfeeding women Patient admission weight greater than 120 kg Patients with any of the following medical history: Active delirium (as defined by Confusion Assessment Method) Dementia Psychosis Glaucoma Heart block (except with patients with a functioning artificial pacemaker) Congestive heart failure (ejection fraction <20% recorded in last year) Adams-Stokes syndrome Wolff-Parkinson-White Syndrome Patient is unable to communicate with staff for pain assessments at time of enrollment Most recent documented Glasgow Coma Score <15 at the time of study enrollment Severe bradycardia (heart rate <50 bpm based on last vital sign recorded at time of study enrollment) Sustained hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg for at least 3 sets of vital signs in a row prior to study enrollment) Any seizure suspected or identified during hospital admission Patient with active acute coronary syndrome obtained from admission problem list Patients with known hepatic disease or acute liver failure a. Acute liver failure on admission defined as either: i. International normalized ratio > 1.5, without being on home anticoagulation ii. Aspartate aminotransferase or Alanine aminotransferase greater than 120 IU/L (3 times upper limit of normal) b. Known hepatic disease defined as past medical history of Child Turcotte Pugh (Child's) score C Patients with a history of end-stage renal disease or admission creatinine clearance (CrCl) ≤30 ml/min a. CrCl will be based on Cockcroft-Gault equation from admission labs Use of antiarrhythmic medication therapy prior or during admission a. Amiodarone, sotalol, dofetilide, dronedarone, mexilitine Patients with a known allergy/sensitivity to lidocaine or ketamine, amide anesthetics, or components of the solution Patients who, in the investigator's opinion, should not be included in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah R Wheeler
Phone
616-486-9834
Email
hannah.wheeler@corewellhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Hoyte, PharmD
Email
brittany.hoyte@spectrumhealth.org
Facility Information:
Facility Name
Spectrum Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah R Wheeler
Phone
616-486-9834
Email
hannah.wheeler@corewellhealth.org
First Name & Middle Initial & Last Name & Degree
Brittany R Hoyte, PharmD
Phone
616-352-2462
Email
brittany.hoyte@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Alistair J Chapman, MD
First Name & Middle Initial & Last Name & Degree
Charles J Gibson, MD
First Name & Middle Initial & Last Name & Degree
Gaby A Iskander, MD
First Name & Middle Initial & Last Name & Degree
Benjamin N Gayed, MD
First Name & Middle Initial & Last Name & Degree
Nicholas C Watson, MD
First Name & Middle Initial & Last Name & Degree
Amy R Spencer, MD
First Name & Middle Initial & Last Name & Degree
Richard S Hagelberg, MD
First Name & Middle Initial & Last Name & Degree
Jess A Spradling, MD
First Name & Middle Initial & Last Name & Degree
Elizabeth A Steensma, MD
First Name & Middle Initial & Last Name & Degree
Amanda Y Yang, MD
First Name & Middle Initial & Last Name & Degree
Brittany R Hoyte, PharmD
First Name & Middle Initial & Last Name & Degree
Cathryn L Chadwick, MD
First Name & Middle Initial & Last Name & Degree
Patricia A Pentiak, MD
First Name & Middle Initial & Last Name & Degree
Douglas R Kwazneski, MD
First Name & Middle Initial & Last Name & Degree
Luke T Durling, MD
First Name & Middle Initial & Last Name & Degree
Kailyn K Hing, MD
First Name & Middle Initial & Last Name & Degree
Calvin J Ice, PharmD
First Name & Middle Initial & Last Name & Degree
Laura A Krech, MPH
First Name & Middle Initial & Last Name & Degree
Jessica L Parker, MS
First Name & Middle Initial & Last Name & Degree
Matthew B Dull, MD
First Name & Middle Initial & Last Name & Degree
Kailyn Kwong-Hing, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ketamine vs Lidocaine in Traumatic Rib Fractures

We'll reach out to this number within 24 hrs