Geriatric Ketamine for Pain Management Study
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|ClinicalTrials.gov Identifier: NCT02673372|
Recruitment Status : Completed
First Posted : February 3, 2016
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
This research project is geared towards geriatric analgesia in the Emergency Department (ED) with a goal of reducing the administration of opioid pain medications to elderly patients, thereby avoiding the commonly occurring, severe side effects associated with such medications, including hypotension, respiratory depression, altered mental status, delirium, as well as nausea/vomiting and constipation.
The primary outcome of the study will be difference in pain score from baseline to 30 minutes post-medication administration.
This project has the potential to change and modify the ED approach to geriatric analgesia by virtue of minimizing the use of opioid administration in elderly patients. T
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Morphine Drug: Ketamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Low-Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department Geriatric Population: A Prospective, Randomized, Double-Blind Study.|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||April 2018|
Active Comparator: Morphine Group
intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.
intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.
Experimental: Ketamine Group
Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)
Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
- Reduction of Pain Score at 30 Minutes [ Time Frame: 30 minutes ]The primary outcome will be the comparative reduction of NRS pain scores between the 2 groups at 30 minutes. The NRS Pain scale ranges from 0 to 10 (0 being no pain at all to 10 being very severe pain; 5 is moderate pain)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673372
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Sergey Motov, MD||Maimonides Medical Center|