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Geriatric Ketamine for Pain Management Study

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
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

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 3, 2016
Results First Submitted Date  ICMJE October 25, 2018
Results First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
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.
Change History Complete list of historical versions of study NCT02673372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Geriatric Ketamine for Pain Management Study
Official Title  ICMJE Low-Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department Geriatric Population: A Prospective, Randomized, Double-Blind Study.
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

Detailed Description

Elderly patients are making up a greater proportion of the New York State population every year as the nation's overall population continues to age at a rapid pace. Acute and chronic pain conditions are very common in the geriatric population and it is well recognized that pain is undertreated in the elderly. Complicating this important public health problem is that changes in physiology that occur in the elderly, such as cognitive decline and impaired ability of the liver and kidney to metabolize medications, render opioid administration particularly dangerous in the geriatric population. Adverse side effects and increased health care utilization are well known hazards associated with opioid use in the elderly.

Therefore, development of pain management strategies that include non-opioid pain treatment modalities has the potential to have a major impact on the health and well-being of New Yorkers. This study undertakes a novel strategy intended to reduce opioid consumption in the elderly.

This research project will evaluate the analgesic feasibility and safety of short infusion of subdissociative dose of intravenous ketamine compared with short infusion of intravenous morphine for controlling pain in ED patients 65 years of age and older, laying the groundwork for ketamine to become a safe and viable alternative to opioids in managing geriatric pain in the ED. The significance of this project being done at Maimonides Medical center is to lay the foundation to providing safer analgesia in geriatric ED patients and moving towards an eventual goal of an "opioid-free" ED.

Methods:

Study Design:

This is a prospective, randomized, double-blind trial evaluating and comparing analgesic effect of Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min), and intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. in elderly adults (age 65 and older) with pain in the ED.

Study

Protocol:

Patient screening, enrollment, and data collection will be performed by study investigators and the research fellow. ED pharmacy investigators will maintain the randomization list which will be generated prior to commencement of the study, will prepare the medication, and will deliver it to the nurse caring for the study participant in a blinded fashion.

The study will include patients aged 65 and older presenting to the ED with abdominal, flank, back, traumatic chest or musculoskeletal pain of (moderate to very severe pain) five or more on a standard eleven point (0 - 10; with 0 being no pain to 10 very severe pain) numeric rating scale (NRS), and who require opioid analgesia as determined by the treating ED attending physician.

Exclusion criteria will include altered mental status, allergy to morphine or ketamine, weight <40kg or >115kg, unstable vital signs (systolic blood pressure <90 or >200 mmHg, heart rate <50 or >150 beats per minute, non-traumatic chest pain, headache, and respirations <8 or >30 per minute), past medical history of severe renal or hepatic insufficiency, alcohol or drug abuse or psychiatric illness; BMI >40; severe COPD

After patients are evaluated by the treating ED physician and determined to meet eligibility criteria, each patient will be approached by a member of the research team for acquisition of written informed consent and HIPAA authorization. The on-duty ED pharmacist will prepare medications according to the two arms of the study: patients receiving 0.1 mg /kg of morphine ; patients receiving 0.3 mg/kg of ketamine.

The medication will be administered using infusion pump with a 10 minute run time.

Patients a priori will will be randomized to either of the two arms. A list will be generated via SPSS 19.0 from 1 to 90; and SPSS 19.0 will be programmed to randomly assign patients to either of the two arms at 10 patient blocks. Thus, for example in patients 1 to 10; SPSS will randomly assign 5 patients to the Ketamine group and 5 patients to the morphine group and so on for all 90 patients. Therefore, after completion 45 patients will be assigned to the Ketamine group and 45 to the morphine group. Antonios will then e-mail the list to Nicholas Filk and pharmacy department who will have the list and when a patient is enrolled in the study will know which medication to give the patient. Every other investigator and clinician would be blinded to the randomization assignment.

Study investigators will record pain scores, vital signs, and adverse effects at 0, 30, 60, 90, and 120 minutes.

Patients who report a pain NRS of five or greater and request additional pain relief will be given fentanyl 0.5 mcg/kg as a rescue analgesic. All data, including gender, demographics, medical history, and vital signs, will be recorded on data collection sheets and will be entered into and analyzed via SPSS 19.0.

Development of the randomization list, confirmation of written consent acquisition on all participants, and statistical analyses will be conducted by the research manager and statistician, who will be independent of any data collection.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Morphine Group
    intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.
    Intervention: Drug: Morphine
  • Experimental: Ketamine Group
    Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)
    Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
90
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 120 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02673372
Other Study ID Numbers  ICMJE 2015-10-14
2015-10-14 ( Other Identifier: Maimonides Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antonios Likourezos, Maimonides Medical Center
Study Sponsor  ICMJE Antonios Likourezos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergey Motov, MD Maimonides Medical Center
PRS Account Maimonides Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP