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Sub-dissociative Dose Ketamine Dosing Study

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ClinicalTrials.gov Identifier: NCT03714620
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 8, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 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.



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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


Contacts
Contact: Shannon Lovett, MD 708-327-2549 slovett@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Shannon Lovett    847-951-2936    slovett@lumc.edu   
Sponsors and Collaborators
Loyola University

Responsible Party: Shannon Lovett, Associate Professor of Department of Emergency Medicine, Loyola University
ClinicalTrials.gov Identifier: NCT03714620     History of Changes
Other Study ID Numbers: 211328
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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