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Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department

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: NCT03436121
Recruitment Status : Withdrawn (Ketamine shortage during the funding period of the trial)
First Posted : February 19, 2018
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
University of Pittsburgh Physicians
Information provided by (Responsible Party):
Maria Pacella, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 11, 2020
Estimated Study Start Date  ICMJE December 2019
Actual Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
Pain Intensity in the ED [ Time Frame: Pain intensity rating in the ED at 1-hour post-study drug administration ]
Pain Numeric Rating Scale (PNRS)- this item is anchored to pain intensity "right now" on a scale from 0(no pain)-10 (worst pain imaginable)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
Pain Intensity at Follow-Up [ Time Frame: Pain Intensity at 1-week post-ED Discharge ]
Pain Numeric Rating Scale (PNRS): this item is anchored to pain intensity within the past 7-days on a scale from 0 (no pain) to 10 (worst pain imaginable)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department
Official Title  ICMJE Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care
Brief Summary In this proposal, the investigators will determine if a single dose of intravenous (IV) ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need for opiate analgesics both in the ED and in the acute recovery period after ED discharge. The investigators will compare the ketamine arm to an active placebo-controlled arm (with midazolam).
Detailed Description

The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.

The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.

All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to either the experimental condition (ketamine + midazolam) or the active control condition (placebo + midazolam)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain
  • Depression
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine is a medication approved by the US Food and Drug Administration (FDA) for anesthesia, sedation, and post-surgical pain treatment. It is not approved for emergency patients complaining of pain but is often used "off-label." Ketamine may be useful for acute pain management and in treatment of depressed mood. The purpose of this study is to determine whether a single low dose of ketamine can relieve pain and reduce negative mood for 2 weeks after emergency department (ED) treatment.
  • Drug: Midazolam
    In this study, all patients will also receive midazolam. Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.
  • Drug: Placebo
    In this study, patients in the active comparator group will receive midazolam first, then placebo. A placebo is an inactive solution that looks like the study drug, but contains no active ingredients.
Study Arms  ICMJE
  • Experimental: Experimental Arm
    Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
    Interventions:
    • Drug: Ketamine
    • Drug: Midazolam
  • Active Comparator: Active Placebo Arm
    Participants will be assigned to receive a single dose of IV placebo + midazolam
    Interventions:
    • Drug: Midazolam
    • Drug: Placebo
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 7, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
120
Actual Study Completion Date  ICMJE February 5, 2020
Actual Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults between the ages of 18-65
  2. A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
  3. Expected to be in the ED for at least 2 hours

Exclusion Criteria:

  1. Non-English speaking
  2. Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns)
  3. Not alert and oriented
  4. Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
  5. Seeking treatment due to a mental health or substance use disorder
  6. History of chronic opioid use
  7. Prescribed opioid use within the past 24 hours
  8. Any use of recreational narcotics throughout lifetime
  9. Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
  10. Weight > 170kg (375 lbs)
  11. Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
  12. Pregnancy
  13. Prisoner
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03436121
Other Study ID Numbers  ICMJE PRO17090065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: There is no plan in place yet because it is undecided whether the investigators will need to share the data with additional investigators/researchers not listed on the protocol.
Current Responsible Party Maria Pacella, University of Pittsburgh
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Maria Pacella
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Pittsburgh Physicians
Investigators  ICMJE
Principal Investigator: Maria L Pacella, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2020

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