NCT06236113

Low Dose Ketamine for Blunt Thoracic Trauma

Low Dose Ketamine for Blunt Thoracic Trauma: A Prospective Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: North Memorial Health Care · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Randomized controlled double-blinded trial is to compare the addition of a ketamine infusion to placebo, when added to standard care in adult blunt trauma patients with multiple rib fractures. The main question it aims to answer are: • addition of low dose ketamine infusion (LDKI) decreases narcotic use • does LDKI impact pulmonary complications, readmission, or hospital length of stay Participants will receive usual standard of care with up to 48 hours of LDKI or placebo. If there is a comparison group: Researchers will compare infusion of a saline infusion to LDKI to see if LDKI decreases need for narcotic analgesics use.

Detailed description

Study Design: Randomized controlled double-blinded trial: Patients will then be randomized into one of two study groups. Both groups will receive a normal saline infusion for 48 hours of therapy. The treatment group will have ketamine added to their saline infusion via blinded pharmacy protocol to receive continuous infusion of ketamine at 0.1mg/kg/hour. The control group will receive only normal saline. Administration will occur via piggyback infusion in accordance with nursing policy. Setting/Participants: * North Memorial Health Hospital: patients on 5-South - Trauma Neuro Intensive Care Unit (TNICU) and 6-West - Trauma Floor * 50 people will take part in this study. 25 study subjects will receive an infusion of ketamine and 25 will receive a saline infusion. * Patients 18 years of age or older with 3 or more rib fractures admitted to North Memorial Health Hospital will be considered for the study. Study Interventions and Measures: * Ketamine low-dose infusion administered at 0.1 mg/kg/hr for 48 hours as an adjunct to standardized rib fracture management interventions as outlined in facility-approved Guidelines for Rib Fracture Management. * The primary study outcome will be amount of narcotic used over the 48-hour study period (expressed as morphine mg equivalents). * Secondary outcome measures will include: need for endotracheal intubation or non-invasive positive pressure ventilation, oxygen requirements, daily incentive spirometer values, daily forced vital capacity measurements, and subjective patient pain ratings. * Other outcomes measured will be Intensive Care Unit stay, total hospital length of stay, and adverse medication effects.

Conditions

• Blunt Injury of Thorax
• Multiple Rib Fractures, Involving Three Ribs

Interventions

Type	Name	Description
DRUG	Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution	administered at rate of 0.1 mg/kg/hr

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-03-19
• Completion: 2023-06-26
• First posted: 2024-02-01
• Last updated: 2024-05-21
• Results posted: 2024-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study