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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
Study 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.Check my eligibility
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.See study design
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 ~ will capture retrospectively after patient's medical discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will capture retrospectively after patient's medical discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse events
Hospital Length of Stay
In-Hospital mortality
+6 moreTrial 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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Ketamine for therapeutic use?
"There is evidence of past successful clinical trials, making Ketamine's safety score a 3."
Answered by AI
What therapeutic purposes is Ketamine commonly employed for?
"Ketamine has multiple uses in medicine, including management of cervical syndrome. It may also be employed for minor burns and general anesthesia during transplantation procedures."
Answered by AI
Are enrollments open for this scientific investigation?
"As indicated on clinicaltrials.gov, enrollment is still ongoing for this research project which was initially publicized on April 1st 2021 and recently revised May 5th 2022."
Answered by AI
How many participants are being included in this medical research?
"Indeed, the information on clinicaltrials.gov affirms that this study has open enrollment and is actively searching for 74 participants across one medical site. This trial was first posted April 1st 2021 with its most recent update being May 5th 2022."
Answered by AI
Have any other experiments been conducted using Ketamine?
"Presently, 211 clinical trials are assessing the efficacy of Ketamine. Of these studies, 47 have advanced to Phase 3 and are currently recruiting patients. Most of the research on this treatment is based in Duarte, California; however 1239 sites across the world are running trials for it."
Answered by AI
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