Comparing Ketamine and Lidocaine for Pain Relief in Rib Fractures
A Prospective, Randomized, Single-Blinded Trial of Ketamine Versus Lidocaine Infusions for Multimodal Pain Management in Traumatic Rib Fracture Patients
This study is testing whether ketamine or lidocaine works better for pain relief in adults with multiple rib fractures to help them breathe easier and avoid complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spectrum Health Hospitals Academic / other |
| Locations | 1 site (Grand Rapids, Michigan) |
| Trial ID | NCT04781673 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of ketamine versus lidocaine infusions for managing pain in adults with traumatic rib fractures. The study aims to optimize pain control to improve respiratory function and reduce complications associated with rib fractures, such as pneumonia and the need for mechanical ventilation. Participants will be adults with three or more rib fractures, enrolled within 16 hours of hospital admission, and assessed for their need for escalated pain management. The trial will compare the opioid-sparing effects of both medications to determine which provides better pain relief.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with three or more traumatic blunt rib fractures requiring advanced pain management.
Not a fit: Patients who may not benefit include those with certain medical histories, such as active delirium, dementia, or those receiving regional anesthesia prior to randomization.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that minimize opioid use and enhance recovery for patients with rib fractures.
How similar studies have performed: While there is limited research directly comparing ketamine and lidocaine for rib fractures, both medications have shown promise in managing postoperative pain in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grand Rapids, Michigan
- Spectrum Health Hospital — Grand Rapids, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Hannah R Wheeler
- Email: hannah.wheeler@corewellhealth.org
- Phone: 616-486-9834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.