Ketamine vs Lidocaine for Rib Fractures

Overseen By Hannah R Wheeler

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brittany Kiracofe

Must not be taking: Antiarrhythmics

Disqualifiers: Dementia, Psychosis, Glaucoma, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 24-72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ketamine and lidocaine can manage pain for individuals with multiple rib fractures from trauma. By comparing these treatments, researchers aim to determine which one better reduces the need for opioid painkillers in the initial days following injury. The study seeks participants with three or more broken ribs from an accident who require stronger pain relief options. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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.

What is the safety track record for ketamine and lidocaine?

Research has shown that both ketamine and lidocaine are generally safe for controlling pain, particularly in cases like rib fractures. Studies have found ketamine to be a promising option for managing this type of pain. It serves as a good alternative to traditional pain treatments and reduces the need for opioids, which are strong and potentially addictive painkillers.

Lidocaine has also been proven safe and effective. It lessens pain and reduces opioid use in patients with rib fractures. Some studies have even used lidocaine in patches and sprays, which show fewer side effects compared to other pain treatments.

Both treatments have been safely used in various forms, such as infusions (medications given through a vein) and topical applications (applied to the skin). This versatility makes them well-tolerated options for managing pain from rib fractures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard care for rib fractures, which typically involves pain management through opioids and other analgesics, ketamine and lidocaine offer unique alternatives. Ketamine is exciting because it acts on NMDA receptors in the brain, potentially providing rapid pain relief and reducing the risk of opioid dependence. On the other hand, lidocaine is a local anesthetic that can be administered intravenously, offering targeted pain relief without the sedative effects often associated with other pain medications. Researchers are eager to see if these treatments can provide effective pain control with fewer side effects, making recovery smoother and safer for patients with rib fractures.

What evidence suggests that this trial's treatments could be effective for rib fractures?

This trial will compare the effectiveness of ketamine and lidocaine infusions for pain control in patients with rib fractures. Research has shown that both ketamine and lidocaine can help manage pain in such patients. Ketamine, known for its pain-relieving effects, significantly eases pain in people with chest injuries compared to other pain medications and reduces the need for opioids, which are strong and potentially addictive painkillers. Lidocaine, a local anesthetic, has also effectively reduced pain in trauma patients with rib fractures. Both treatments offer promising alternatives to traditional pain management, particularly in reducing opioid use. Participants in this trial will receive either ketamine or lidocaine as part of separate treatment arms. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

≥ 3 traumatic blunt rib fractures

Enrollment within 16 hours of being admitted to the hospital

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine
• Lidocaine

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30376537/

Ketamine infusion for pain control in adult patients with ... Low-dose ketamine failed to decrease NPS or OME within the overall cohort, but a decrease in OME was observed among patients with an ISS greater than 15.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4989044/

Ketamine Infusion Therapy as an Alternative Pain Control ... Ketamine is a promising alternative agent for pain control that offers benefit to traditional strategies, particularly in the setting of rib fracture.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02432456

Ketamine Infusion Therapy for the Management of Acute ... This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt ...

4. researchgate.net researchgate.net/publication/387573103_Comparison_of_the_analgesic_dose_of_intravenous_ketamine_versus_ketorolac_in_patients_with_chest_trauma_A_randomized_double-blind_clinical_trial

Comparison of the analgesic dose of intravenous ketamine ... Results Pain was more significantly relieved in the ketamine group, 30 and 60 min after drug administration, compared to ketorolac (median [IQR] ...

5. vetcot.org vetcot.org/the-journal-club/ketamine-infusion-for-pain-control-in-adult-patients-with-multiple-rib-fractures-results-of-a-randomized-control-trial-2/

Ketamine infusion for pain control in adult patients ... Read more: Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. Link to full article ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02432456

Ketamine Infusion Therapy for the Management of Acute ... This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt ...

7. aast.org aast.org/asset/F70AF55F-112A-4D08-BEB81E0EB308B82C/

Ketamine infusion for pain control in elderly patients with ... Ketamine infusion for pain control in adult patients with multiple rib fractures: results of a randomized control trial. J Trauma. Acute Care ...