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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will capture retrospectively after patient's medical discharge
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare ketamine and lidocaine infusions to reduce opioid consumption in the first 72 hours for patients with multiple traumatic rib fractures.
Who is the study for?
Adults over 18 with at least three traumatic rib fractures, enrolled within 16 hours of hospital admission. Not for those already on certain pain treatments, with severe brain injury, communication barriers, extreme weight or specific medical conditions like heart failure, liver disease or kidney failure. Pregnant/breastfeeding women and prisoners are excluded.
What is being tested?
The trial is testing ketamine versus lidocaine infusions to manage pain and reduce opioid use in the first 72 hours after multiple traumatic rib fractures. It aims to see which drug works better for pain control without relying heavily on opioids.
What are the potential side effects?
Ketamine may cause changes in blood pressure, abnormal dreams, dizziness or nausea. Lidocaine could lead to numbness around the mouth, tingling sensations, lightheadedness or a drop in blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-24; 24-48; 48-72 hours post infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24; 24-48; 48-72 hours post infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Adverse events
Hospital Length of Stay
In-Hospital mortality
+6 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: KetamineActive Control1 Intervention
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.
Group II: LidocaineActive Control1 Intervention
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.
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Who is running the clinical trial?
Brittany KiracofeLead Sponsor
Brittany HoyteLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received certain types of anesthesia or pain relief medications before participating in the study.You have any of the following medical conditions in your past:Your most recent recorded Glasgow Coma Score is less than 15 when you join the study.The doctor thinks you may need stronger pain management in the future and could benefit from being part of this study to help control your pain.You are allergic to lidocaine, ketamine, or other similar medications used for numbing or anesthesia.You currently have a severe state of confusion called delirium.You have a condition called dementia, which affects your memory and thinking abilities.You have a mental condition called psychosis.You have a heart condition called heart block, unless you have a working artificial pacemaker.You have a condition called Adams-Stokes syndrome.You have a heart condition called Wolff-Parkinson-White Syndrome.You had a suspected or confirmed seizure while in the hospital.You are taking medication for heart rhythm problems before or during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
- Group 2: Lidocaine
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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