Geriatric Ketamine for Pain Management Study
Condition: Pain
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Morphine; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Geriatric, Pain, Ketamine, Emergency Medicine