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Ketamine For Acute Treatment of Pain in Emergency Department (KETAFAP)

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ClinicalTrials.gov Identifier: NCT02306759
Recruitment Status : Completed
First Posted : December 3, 2014
Results First Posted : June 1, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Billy Sin, The Brooklyn Hospital Center

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.


Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine Drug: Placebo Phase 4

Detailed Description:
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.

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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: Ketamine For Acute Treatment of Pain in Emergency Department
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Treatment
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Drug: Ketamine
Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes

Placebo Comparator: Placebo
Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Drug: Placebo
Normal saline 50ml, administered over 15 minutes




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02306759


Locations
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United States, New York
The Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Sponsors and Collaborators
The Brooklyn Hospital Center
Investigators
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Principal Investigator: Billy Sin, Pharm.D. The Brooklyn Hospital Center

Publications:
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Responsible Party: Billy Sin, Emergency Medicine Clinical Pharmacy Educator, The Brooklyn Hospital Center
ClinicalTrials.gov Identifier: NCT02306759     History of Changes
Other Study ID Numbers: 669443-1
First Posted: December 3, 2014    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: August 9, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Billy Sin, The Brooklyn Hospital Center:
analgesia
ketamine
pain

Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action