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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Spectrum Health Hospital

Grand Rapids, Michigan, United States, 49503

Ketamine vs Lidocaine in Traumatic Rib Fractures | DecenTrialz