Active, Not RecruitingPhase 4ketamine

Ketamine vs Lidocaine in Traumatic Rib Fractures

Sponsored by Brittany Hoyte

NCT ID
NCT04781673
Target Enrollment
74 participants
Start Date
2021-04-01
Est. Completion
2026-07

About This Study

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 as the need for mechanical ventilation, hospital or ventilator associated pneumonia, atelectasis, and acute respiratory distress syndrome. Effective multimodal pain management is needed to optimize a patient's respiratory status and can also play a role in early mobility, less pulmonary complications, shorter ICU and hospital length of stay, and decreased mortality. Current multimodal pain management options include opioids, muscle relaxants, gabapentin, acetaminophen, nonsteroidal anti-inflammatory drugs, and various regional/neuraxial anesthesia techniques. Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective, with the benefit of minimizing the use of opioids. However, there have been very few studies that have used ketamine or lidocaine infusions for pain control specifically in patients with traumatic rib fractures. Therefore, the purpose of this study is to evaluate ketamine versus lidocaine infusions as an adjunctive therapy to reduce opioid consumption in the first 72 hours in patients with multiple traumatic rib fractures.

Conditions Studied

Rib FracturesRib Fracture MultipleRib Trauma

Interventions

  • Ketamine
  • Lidocaine

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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.

Study Locations (1)

Corewell Health West
Grand Rapids, Michigan, United States

This trial is not recruiting

This study is currently not accepting new participants.

Find recruiting trials
Data Source
ClinicalTrials.gov

Last updated from source