Low Dose Ketamine for Blunt Thoracic Trauma

NCT ID: NCT06236113

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-06-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo/Control

Pharmacist will check randomization schedule. For placebo/control subject they will prepare an infusion bag of saline with no added medication. The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient (Pt) Name, Pt Medical record number (MR#), Pt Date of birth (DOB), and INFUSION RATE.

Group Type: PLACEBO_COMPARATOR

Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution

Intervention Type: DRUG

administered at rate of 0.1 mg/kg/hr

Low Dose Ketamine Infusion (LDKI)

Infusion Bag will receive 100 mg of ketamine (Ketamine Infusion Subject). The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient Name, Pt MR#, Pt DOB, and INFUSION RATE. (Note: infusion rate is 0.1 mg/kg/hr and concentration of standard ketamine infusion bag is 1 mg/mL. That is, 100 mg of ketamine added to 100 mL saline).

Group Type: EXPERIMENTAL

Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution

Intervention Type: DRUG

administered at rate of 0.1 mg/kg/hr

Interventions

Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution

administered at rate of 0.1 mg/kg/hr

Intervention Type: DRUG

Other Intervention Names

Low Dose Ketamine Infusion; Ketamine Drip

Eligibility Criteria

Inclusion Criteria

• Males or females 18 years of age or older
• Diagnosis of 3 or more acute rib fractures related to blunt traumatic chest injury.
• Able to undergo consent procedure and give valid consent, or availability of family member to provide consent for the study

Exclusion Criteria

• Age <18 years
• Cognitively impaired
• Pregnant or lactating females.
• Glasgow Coma Score (GCS) of ≤ 14 at time of admission
• Evidence of increased intraocular pressure
• Presence of acute coronary syndrome
• Diagnosed moderate to severe traumatic brain injury
• Evidence of uncontrolled intracranial hypertension
• History of seizures or stroke
• History of severe psychiatric disorders
• Allergy to ketamine
• Currently being treated, prior to admission, with opiate agonist/antagonist therapy
• Presence of poorly controlled hypertension, cardiac arrhythmias, and/or tachycardia on admission
• Subjects who, in the opinion of the Investigator, may be inappropriate for study participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Memorial Health Care

OTHER

Sponsor Role: lead

Responsible Party

Michaela A West

Trauma Research Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michaela A West, MD, PhD

Role: STUDY_DIRECTOR

North Memorial Health

Joseph Farhat, MD

Role: PRINCIPAL_INVESTIGATOR

North Memorial Health

Locations

North Memorial Health Hospital

Robbinsdale, Minnesota, United States

Countries

United States

References

Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.

Reference Type: BACKGROUND

PMID: 29607659 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

04/18/46

Identifier Type: -

Identifier Source: org_study_id