Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
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
Official Title: A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: 0.15 mg/kg IV Ketamine Drug: Ketamine
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

Active Comparator: 0.3 mg/kg IV Ketamine Drug: Ketamine
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Need for rescue medications at 60 minutes [ Time Frame: 60 minutes ]
    Patient request for additional pain medications at 60 minutes

  5. Change in heart rate [ Time Frame: 60 minutes ]
  6. Change in systolic/diastolic blood pressure [ Time Frame: 60 minutes ]
  7. Change in oxygen saturation [ Time Frame: 60 minutes ]
  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03714620


Locations
Layout table for location information
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Layout table for additonal information
Responsible Party: Shannon Lovett, Associate Professor of Department of Emergency Medicine, Loyola University
ClinicalTrials.gov Identifier: NCT03714620    
Other Study ID Numbers: 211328
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations
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