Ketamine vs Lidocaine in Traumatic Rib Fractures

NCT04781673 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2019-508
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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 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

Rib Fractures; Rib Fracture Multiple; Rib Trauma

Keywords

Lidocaine; Ketamine; Rib Fracture; Traumatic Rib Fracture

Outcome Measures

Primary Outcomes (1)

• Oral Morphine Equivalent - Opioid Usage

  Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg.

  0-24 hours post infusion

Secondary Outcomes (9)

• Visual Analogue Numeric Pain Score

  0-24; 24-48; 48-72 hours post infusion

• Oral Morphine Equivalent - Opioid Usage

  24-48; 48-72 hours post infusion

• Respiratory Failure

  0-30 days post-infusion

• Use of Regional/Neuraxial anesthesia

  0-30 days post infusion

• Hospital Length of Stay

  Will capture retrospectively after patient's medical discharge

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

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.

Drug: Ketamine

Lidocaine

ACTIVE COMPARATOR

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.

Drug: Lidocaine

Interventions

Ketamine DRUG

Will receive titratable infusion.

Also known as: Ketalar

Ketamine

Lidocaine DRUG

Will receive titratable infusion, will have daily lidocaine level labs drawn daily.

Also known as: Xylocaine

Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brittany Hoyte: lead

Study Sites (1)

Corewell Health West

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Rib Fractures

Interventions

Ketamine; Lidocaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Medication infusion and medication IV bag will be covered with brown protect from light bag
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Randomized Trial, Single-blinded

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 4, 2021
• Study Start: April 1, 2021
• Primary Completion: October 10, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)