Geriatric Ketamine for Pain Management Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02673372 |
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Recruitment Status :
Completed
First Posted : February 3, 2016
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
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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 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Morphine Group
intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.
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Drug: Morphine
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. |
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Experimental: Ketamine Group
Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)
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Drug: Ketamine
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)
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| Ages Eligible for Study: | 65 Years to 120 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ED patients; 65 years of age and older; abdominal, flank, back, traumatic chest, neck or musculoskeletal pain; capacity to give verbal or written consent.
Exclusion Criteria:
- ED patients <65 years old; altered mental status; presenting with headache, non-traumatic chest pain; allergy to morphine or ketamine; weight <40kg or >115kg, unstable vital signs (systolic blood pressure <90 or >180 mmHg; heart rate <5 or >150 beats per minute; and respirations <8 or >30 per minute), and past medical history of severe renal or hepatic insufficiency, alcohol or drug abuse or psychiatric illness; Patients with BMI>40; severe COPD
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 |
Documents provided by Antonios Likourezos, Maimonides Medical Center:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Antonios Likourezos, Research Manager, Maimonides Medical Center |
| ClinicalTrials.gov Identifier: | NCT02673372 History of Changes |
| Other Study ID Numbers: |
2015-10-14 2015-10-14 ( Other Identifier: Maimonides Medical Center ) |
| First Posted: | February 3, 2016 Key Record Dates |
| Results First Posted: | May 31, 2019 |
| Last Update Posted: | May 31, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Geriatric, Pain, Ketamine, Emergency Medicine |
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Morphine Ketamine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |