ACTIVE_NOT_RECRUITING

Ketamine vs Lidocaine in Traumatic Rib Fractures

Conditions

Rib Fractures Rib Fracture Multiple Rib Trauma Lidocaine Ketamine Rib Fracture Traumatic Rib Fracture

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Randomized, Single-Blinded Trial of Ketamine Versus Lidocaine Infusions for Multimodal Pain Management in Traumatic Rib Fracture Patients

Quick Facts

Study Start:2021-04-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04781673

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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 15. Patients with a history of end-stage renal disease or admission creatinine clearance (CrCl) ≤30 ml/min 16. Use of antiarrhythmic medication therapy prior or during admission 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.

Inclusion Criteria

Exclusion 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.

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
15. Patients with a history of end-stage renal disease or admission creatinine clearance (CrCl) ≤30 ml/min
16. Use of antiarrhythmic medication therapy prior or during admission
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.

Contacts and Locations

Study Locations (Sites)

Spectrum Health Hospital

Grand Rapids, Michigan, 49503

United States

Collaborators and Investigators

Sponsor: Brittany Hoyte

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Lidocaine
Ketamine
Rib Fracture
Traumatic Rib Fracture

Additional Relevant MeSH Terms

Rib Fractures
Rib Fracture Multiple
Rib Trauma