Ketamine vs Lidocaine for Rib Fractures

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Brittany Kiracofe

Must not be taking: Antiarrhythmics

Disqualifiers: Dementia, Psychosis, Glaucoma, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using regional/neuraxial anesthetic techniques, ketamine infusion, or antiarrhythmic medications, you may not be eligible to participate.

How does the drug ketamine differ from other treatments for rib fracture pain?

Ketamine is unique for rib fracture pain management because it can reduce the need for opioids, which are commonly used but have significant side effects. Unlike other treatments, ketamine can be administered as an infusion and has been shown to maintain stable pain control without causing respiratory complications like pneumonia. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

Adults over 18 with at least three traumatic rib fractures, enrolled within 16 hours of hospital admission. Not for those already on certain pain treatments, with severe brain injury, communication barriers, extreme weight or specific medical conditions like heart failure, liver disease or kidney failure. Pregnant/breastfeeding women and prisoners are excluded.

Inclusion Criteria

The doctor thinks you may need stronger pain management in the future and could benefit from being part of this study to help control your pain.

Adults ≥ 18 years old

≥ 3 traumatic blunt rib fractures

Exclusion Criteria

You have received certain types of anesthesia or pain relief medications before participating in the study.

You have any of the following medical conditions in your past:

Your most recent recorded Glasgow Coma Score is less than 15 when you join the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

16 hours

1 visit (in-person)

Treatment

Participants receive either ketamine or lidocaine infusion for pain control, along with standard of care

24-72 hours

Continuous monitoring (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and pain score assessments

0-30 days

Daily assessments (in-patient)

Treatment Details

Interventions

• Ketamine (NMDA Receptor Antagonist)
• Lidocaine (Local Anesthetic)

Trial Overview The trial is testing ketamine versus lidocaine infusions to manage pain and reduce opioid use in the first 72 hours after multiple traumatic rib fractures. It aims to see which drug works better for pain control without relying heavily on opioids.

Participant Groups

Group I: Ketamine Active Control 1 Intervention

Infusion initiation: 0.1 mg/kg/hr Max: 0.3 mg/kg/hr Recommended titration: 0.1 mg/kg/hr\* as needed every 4 hours based on pain scores ≥5 and physician order Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.

Group II: Lidocaine Active Control 1 Intervention

Infusion initiation: 1 mg/kg/hr Max: 2 mg/kg/hr Recommended titration:0.25 mg/kg/hr\* as needed every 4 hours based on pain scores ≥5 and physician order Dosing will be based on patient actual body weight (ABW) recorded as dosing weight on time of hospital admission.

Who Is Running the Clinical Trial?

Brittany Kiracofe

Lead Sponsor

Trials

1

Recruited

70+

Brittany Hoyte

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

In a case series of three patients with rib fractures, ketamine infusions were associated with reduced opioid use while maintaining stable pain scores, suggesting its efficacy as a pain management strategy.

Although one patient experienced dissociative side effects leading to a reduction and eventual discontinuation of ketamine, no serious pulmonary complications occurred, indicating a favorable safety profile for ketamine in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Infusion Therapy as an Alternative Pain Control Strategy in Patients with Multi-Trauma including Rib Fracture; Case Report and Literature Review. Losing, AK., Jones, JM., Keric, A., et al.[2022]

In a study of 30 ICU patients with rib fractures, the use of low-dose ketamine as an adjuvant treatment significantly reduced pain scores and opioid consumption compared to standard care alone.

The ketamine group experienced lower average pain scores (4.1 vs 5.8) and reduced opioid use (2.5 vs 3.5 mg morphine equivalents per day), while showing no significant differences in length of hospital stay or mortality, indicating its safety and efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Walters, MK., Farhat, J., Bischoff, J., et al.[2019]

In a clinical trial involving 30 children aged 1 to 7 years, oral ketamine (10 mg/kg) significantly improved tolerance to pain during laceration repair compared to a placebo, with notable reductions in pain during lidocaine injection and suturing.

The ketamine group also achieved a higher level of sedation without significant respiratory or circulatory side effects, although 26% experienced minor, transient adverse effects, indicating that ketamine is a safe and effective option for sedation and analgesia in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oral ketamine for providing sedation and analgesia to children requiring laceration repair. Qureshi, FA., Mellis, PT., McFadden, MA.[2022]

Ketamine alone was found to be insufficient for providing pain relief during surgical procedures in rabbits, specifically for ventral abdominal incisions and femur exposure.

The combination of ketamine and xylazine resulted in adequate analgesia for both surgical procedures, indicating that xylazine enhances the pain-relieving effects of ketamine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of ketamine and the combination ketamine-xylazine for effective surgical anesthesia in the rabbit. White, GL., Holmes, DD.[2013]

In a study of 60 pediatric patients undergoing extracorporeal shock wave lithotripsy (ESWL), the ketamine-fentanyl (KF) combination demonstrated better hemodynamic stability and fewer side effects compared to the ketamine-midazolam (KM) combination.

Both groups had similar recovery and discharge times, but the KF group reported lower pain levels and better overall comfort during the procedure, indicating it may be a more effective anesthetic option for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Ketamine with Midazolam versus Ketamine with Fentanyl for Pediatric Extracorporeal Shock Wave Lithotripsy Procedure: A Randomized Controlled Study. Akelma, H., Kiliç, ET., Salik, F., et al.[2022]

References

1. Iran pubmed.ncbi.nlm.nih.gov

Ketamine Infusion Therapy as an Alternative Pain Control Strategy in Patients with Multi-Trauma including Rib Fracture; Case Report and Literature Review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of oral ketamine for providing sedation and analgesia to children requiring laceration repair. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of ketamine and the combination ketamine-xylazine for effective surgical anesthesia in the rabbit. [2013]

5. India pubmed.ncbi.nlm.nih.gov

Comparison of Ketamine with Midazolam versus Ketamine with Fentanyl for Pediatric Extracorporeal Shock Wave Lithotripsy Procedure: A Randomized Controlled Study. [2022]