Phase 4
N=50
Low Dose Ketamine for Blunt Thoracic Trauma
Blunt Injury of Thorax · Multiple Rib Fractures, Involving Three Ribs
Bottom Line
View on ClinicalTrials.gov: NCT06236113 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
May 2024
Primary outcome: Primary: Milligrams of Morphine Equivalents (MME) Administered — 84.9; 81.7 Morphine Milligam Equivalents (MME)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- North Memorial Health Care
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Milligrams of Morphine Equivalents (MME) Administered |
84.9; 81.7 | — |
| SECONDARY Pulmonary Complications |
3; 0; 8; 9; 1; 1 | — |
| SECONDARY ICU Admission or Hospital Readmission |
2; 0; 3; 1; 20; 23 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06236113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.