Ketamine For Acute Treatment of Pain in Emergency Department

Ketamine

Brief Summary

The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department. The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
  • Placebo (DRUG)
    Normal saline 50ml, administered over 15 minutes

Condition or Disease

  • Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2015
    Primary Completion: Nov 01, 2015 ACTUAL
    Completion Date: Nov 01, 2015 ACTUAL
    Study First Posted: Dec 03, 2014 ESTIMATED
    Results First Posted: Jun 01, 2017 ACTUAL
    Last Updated: Jul 11, 2017

    Sponsors / Collaborators

    Lead Sponsor: The Brooklyn Hospital Center
    Responsible Party: Billy Sin

    Location

    Brooklyn, New York, USA

    The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.

    Participant Groups

    • Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals

    • Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients 18 years old and older presenting with acute generalized pain
    * Describes pain to be greater than or equal to 3 on the Visual Analogue Scale (VAS)
    * Provides informed consent

    Exclusion Criteria:

    * Patients who are admitted to the hospital
    * Severe hypertension(≥180/100)
    * Presence of or suspected for traumatic head injury with or without loss of consciousness
    * Presence of or suspected for myocardial ischemia
    * Presence of or suspected alcohol intoxication
    * Hemodynamic instability
    * History of schizophrenia
    * History of Sickle cell crisis / presenting with acute sickle cell crisis
    * History of or suspected recreational substance abuse
    * History of or suspected diagnosis of headache or migraine
    * History of or suspected diagnosis increase in intracranial/intraocular pressure
    * Known or suspected pregnancy
    * Allergy to ketamine or morphine
    * Administration of opioids in previous 4 hours
    * Patients with language barriers or in altered mental status who are unable to describe pain
    * Patients weighing over 166kg

    Primary Outcomes

    • Change from Baseline of Pain as described by Numeric Rating Scale (NRS) \[minimum:0, maximum 10\] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.

    Secondary Outcomes

    • Incidence or number of participants with adverse events.

    • Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.

    • Mean Consumption of Rescue Analgesia at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)

    • ED Length of stay (minutes) throughout study period

    More Details

    NCT Number: NCT02306759
    Acronym: KETAFAP
    Other IDs: 669443-1
    Study URL: https://clinicaltrials.gov/study/NCT02306759
    Last updated: Sep 29, 2023