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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
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Morphine Group
intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.
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.

Experimental: Ketamine Group
Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)
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.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Sergey Motov, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:

Publications:
Gibson SJ. Pain and ageing: a comparison of the pain experience over the adult life span. Prog Pain Res Manage. 2003;24:767-90.
Gibson SJ, Farrell M. What is different about pain in older people? Reviews in Analgesia. 2004;8:23-37.
Gibson SJ. Older Persons' Pain: what can we learn? Pain Clin Updat. 2006;14:1-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Antonios Likourezos, Maimonides Medical Center:
Geriatric, Pain, Ketamine, Emergency Medicine
Additional relevant MeSH terms:
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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