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

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: 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

Tracking Information
First Submitted Date  ICMJE November 25, 2014
First Posted Date  ICMJE December 3, 2014
Results First Submitted Date  ICMJE January 31, 2017
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date August 9, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
Change from Baseline of Pain as described by VAS [ Time Frame: at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
  • Number of Participants With Adverse Events [ Time Frame: during the study period ]
    Incidence or number of participants with adverse events.
  • 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.
  • Mean Consumption of Rescue Analgesia [ Time Frame: at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes) ]
  • ED Length of Stay (Minutes) [ Time Frame: throughout study completion ]
    ED Length of stay (minutes) throughout study period
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
  • Incidence of adverse events [ Time Frame: at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes ]
  • Patient satisfaction of pain control based on a Likert Scale [ Time Frame: at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes ]
  • The number of patients who consumed an adjuvant pain medication for analgesia [ Time Frame: at 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes ]
  • ED Length of stay [ Time Frame: Total length of stay per patient ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine For Acute Treatment of Pain in Emergency Department
Official Title  ICMJE Ketamine For Acute Treatment of Pain in Emergency Department
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.

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.
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: Ketamine
    Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
  • Drug: Placebo
    Normal saline 50ml, administered over 15 minutes
Study Arms  ICMJE
  • 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
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
    Intervention: Drug: Placebo
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: December 1, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, 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 NCT02306759
Other Study ID Numbers  ICMJE 669443-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Billy Sin, The Brooklyn Hospital Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Brooklyn Hospital Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Billy Sin, Pharm.D. The Brooklyn Hospital Center
PRS Account The Brooklyn Hospital Center
Verification Date July 2017

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