Status:
ACTIVE_NOT_RECRUITING
Ketamine vs Lidocaine in Traumatic Rib Fractures
Lead Sponsor:
Brittany Hoyte
Conditions:
Rib Fractures
Rib Fracture Multiple
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04781673
Start Date
April 1 2021
End Date
January 1 2026
Last Update
August 11 2025
Active Locations (1)
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1
Spectrum Health Hospital
Grand Rapids, Michigan, United States, 49503