Ketamine Vs Lidocaine in Traumatic Rib Fractures
Launched by BRITTANY HOYTE · Mar 1, 2021
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of two medications, ketamine and lidocaine, to help manage pain in adults who have experienced multiple rib fractures due to trauma. Rib fractures can cause significant pain and make it difficult to breathe, which can lead to serious complications. The goal of the study is to see if these medications can reduce the need for stronger painkillers, like opioids, in the first 72 hours after injury.
To participate, individuals must be at least 18 years old and have at least three rib fractures. They should be enrolled in the study within 16 hours of being admitted to the hospital for their injuries. However, some people may not qualify due to certain health conditions or if they are receiving specific treatments. If eligible, participants can expect to receive one of the two medications for pain relief and will be monitored for their pain levels and overall recovery. This study aims to improve pain management and help patients recover more effectively after rib injuries.
Gender
ALL
Eligibility criteria
- 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.
About Brittany Hoyte
Brittany Hoyte is a dedicated clinical trial sponsor committed to advancing medical research through innovative and ethical study designs. With a strong focus on patient-centered outcomes, Brittany leads initiatives that prioritize safety, efficacy, and regulatory compliance. Her extensive experience in clinical operations and strategic planning enables the efficient execution of trials across various therapeutic areas. By fostering collaboration among stakeholders, Brittany aims to bridge the gap between scientific discovery and clinical application, ultimately contributing to the improvement of healthcare outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Grand Rapids, Michigan, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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