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Sub-dissociative Dose Ketamine Dosing Study

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: NCT03714620
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shannon Lovett, Loyola University

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE October 15, 2018
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Reduction in pain score from baseline to 30 minutes post initiation of drug administration [ Time Frame: 30 minutes ]
Reduction in pain score from time 0 to time 30 min
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Reduction in pain score from baseline to 15 minutes [ Time Frame: 15 minutes ]
    Reduction in pain score from time 0 to time 15 min post initiation of drug administration
  • Reduction in pain score from baseline to 60 minutes [ Time Frame: 60 minutes ]
    Reduction in pain score from time 0 to time 60 min post initiation of drug administration
  • Need for rescue medications at 30 minutes [ Time Frame: 30 minutes ]
    Patient request for additional pain medications at 30 minutes post initiation of drug administration
  • Need for rescue medications at 60 minutes [ Time Frame: 60 minutes ]
    Patient request for additional pain medications at 60 minutes
  • Change in heart rate [ Time Frame: 60 minutes ]
  • Change in systolic/diastolic blood pressure [ Time Frame: 60 minutes ]
  • Change in oxygen saturation [ Time Frame: 60 minutes ]
  • Adverse effects at 30 min [ Time Frame: 30 minutes ]
    Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
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 Sub-dissociative Dose Ketamine Dosing Study
Official Title  ICMJE A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
Brief Summary Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
Detailed Description

Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.

Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE Drug: Ketamine
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Study Arms  ICMJE
  • Active Comparator: 0.15 mg/kg IV Ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: 0.3 mg/kg IV Ketamine
    Intervention: Drug: Ketamine
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2018)
98
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 17, 2019
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults ages 18-59
  • Weight 45 - 115 kg
  • Acute abdominal, flank, back, musculoskeletal pain, or a headache
  • Onset of pain within 7 days
  • Pain score of 5 or more
  • Requiring intravenous analgesia
  • Hasn't been enrolled in this study previously

Exclusion Criteria:

  • Pregnancy
  • Breast-feeding
  • Altered mental status rendering the patient unable to consent to the study
  • Allergy to ketamine
  • Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/minute, and respiration rate <10 or >30 breaths/minute)
  • History of acute head or eye injury, seizure, intracranial hypertension
  • Chronic pain
  • Renal or hepatic insufficiency
  • Known alcohol or drug use disorder
  • Currently under influence of alcohol/opiates
  • Acute psychiatric illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03714620
Other Study ID Numbers  ICMJE 211328
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.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shannon Lovett, Loyola University
Study Sponsor  ICMJE Loyola University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Loyola University
Verification Date October 2019

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