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Completed

NCT Number: NCT02306759

Ketamine For Acute Treatment of Pain in Emergency Department

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes

Placebo

Drug

Normal saline 50ml, administered over 15 minutes

Primary outcomes

  1. Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes

    Time frame: 15 minutes after administration of study intervention

    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

  1. Number of Participants With Adverse Events

    Time frame: during the study period

    Incidence or number of participants with adverse events.

  2. Patient Satisfaction of Pain Control Based on a Likert Scale

    Time frame: At the end of study period

    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.

  3. Mean Consumption of Rescue Analgesia

    Time frame: at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)

  4. ED Length of Stay (Minutes)

    Time frame: throughout study completion

    ED Length of stay (minutes) throughout study period

Sponsors and collaborators

Lead sponsor

The Brooklyn Hospital Center

Other

Registry information

Acronym: KETAFAP

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2014
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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