Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06236113 |
Other study ID # |
04/18/46 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 1, 2021 |
Est. completion date |
June 26, 2023 |
Study information
Verified date |
February 2024 |
Source |
North Memorial Health Care |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.