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Ketamine for Pain in the Emergency Department

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ClinicalTrials.gov Identifier: NCT03896230
Recruitment Status : Active, not recruiting
First Posted : March 29, 2019
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date January 6, 2021
Actual Study Start Date  ICMJE May 3, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
Pain score [ Time Frame: 2 hours post infusion completion ]
Pain score using Numerical Rating Scale (NRS) post ketamine infusion. The Numerical Rating Scale (NRS) ranges from 0-to-10 with 0 being no pain and lower numbers representing less pain, so in this case lower numbers will represent better outcomes.
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Pain score [ Time Frame: 2 hours post infussion complesion ]
Pain score using Numerical Rating Scale (NRS) post ketamine infusion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
Adverse Events [ Time Frame: 2 hours post infusion completion ]
Frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Adverse Events [ Time Frame: 2 hours post infussion complesion ]
Frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Pain in the Emergency Department
Official Title  ICMJE Comparison of Ketamine 0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg Intravenous Doses for Acute Pain in the Emergency Department: A Prospective, Randomized, Double-blind, Active-controlled, Clinical Trial
Brief Summary This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults < 65 years old and > 65 years old).
Detailed Description

A literature review was performed that searched for randomized clinical trials involving ketamine IV boluses for acute pain in the Emergency Department. Studies involving continuous infusions or intranasal routes of ketamine administration were not included. Thirteen randomized clinical trials were identified meeting this criteria. None of these trials directly compared ketamine doses within the 0.1-0.3 mg/kg range for pain score reduction and adverse events. Many of these trials concluded with the recommendation that further studies were needed to evaluate the optimal dosing of ketamine for acute pain and determine which populations are most ideal for its use. This study will be the first to evaluate ketamine for acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg IV) to determine which dose correlates with the most efficacy and safety.

This study will include the following procedures:

  • Patient consent, screening, and enrollment will be performed by the treating resident or attending who will remain blinded
  • Patient will be assigned a subject number
  • Treating resident or attending will notify the ED pharmacist that a patient has been enrolled in the trial
  • ED pharmacist will notify the IV room and place the study drug order
  • Either the ED pharmacist or a pharmacy supervisor will randomize the subject based on the predetermined randomization list
  • Study drug will be prepared as 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg IV dose in a 100 mL solution of dextrose 5% or sodium chloride 0.9%
  • ED pharmacist will promptly deliver the study drug to the ED
  • Baseline vital signs will be assessed prior to starting the study drug infusion
  • Study drug will be administered via IV infusion over 20 minutes
  • Treating resident or attending will reassess the patient at 15 minutes from the end of infusion, at 30 minutes from the end of infusion, and then every 30 minutes for up to 120 minutes or until discharge, whichever is sooner
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
3 arms each arm getting a different dose of ketamine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blinded study (only the pharmacist supervisor that has no other involvement with the study will know the dose)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered.
Study Arms  ICMJE
  • Active Comparator: Arm 1: 0.1 mg/kg ketamine
    0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
    Intervention: Drug: Ketamine Injectable Product
  • Active Comparator: Arm 1: 0.2 mg/kg ketamine
    0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
    Intervention: Drug: Ketamine Injectable Product
  • Active Comparator: Arm 1: 0.3 mg/kg ketamine
    0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
    Intervention: Drug: Ketamine Injectable Product
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute pain (including acute on chronic pain)
  • Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale
  • Provider determines the patient requires intravenous ketamine for analgesia

Exclusion Criteria:

  • History of hypersensitivity to ketamine
  • Altered mental status
  • Psychiatric illness
  • Known history of renal or hepatic insufficiency
  • Acute head or eye injury
  • Suspected intracranial hypertension or mass
  • Headache as the chief complaint
  • Alcohol or drug abuse
  • Received an analgesic within the last four hours
  • History of congestive heart failure
  • History of aortic or brain aneurysm
  • Active Chest Pain
  • Porphyria
  • Active methadone treatment
  • Pregnant or breastfeeding
  • Signs of respiratory, hemodynamic, or neurologic compromise

    • Systolic blood pressure < 90 mmHg or > 180 mmHg
    • Heart rate < 50 beats per minute or > 150 beats per minute
    • Respiratory rate < 10 breaths per minute or > 30 breaths per minute
    • Glasgow Coma Score < 15
  • Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (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 NCT03896230
Other Study ID Numbers  ICMJE Pro2018-0970
Has Data Monitoring Committee No
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: All study related materials will be kept confidential as required by law. Written documentation and computer files will remain in a locked or password protected location, with access given to those directly responsible for the conduct of the study. In addition, all information will be recorded in such a manner that subjects whose data is included in the analysis cannot be identified directly or through identifiers linked to the subjects.
Responsible Party Hackensack Meridian Health
Study Sponsor  ICMJE Hackensack Meridian Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hackensack Meridian Health
Verification Date January 2021

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