Sub-dissociative Dose Ketamine Dosing Study

Ketamine

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.

Intervention / Treatment

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.
  • Ketamine (DRUG)
    Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes

Condition or Disease

  • Acute Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 59 Years
    Enrollment: 98 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    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.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Oct 15, 2018 ACTUAL
    Primary Completion: Sep 17, 2019 ACTUAL
    Completion Date: Sep 17, 2019 ACTUAL
    Study First Posted: Oct 22, 2018 ACTUAL
    Results First Posted: Aug 09, 2022 ACTUAL
    Last Updated: Aug 08, 2022

    Sponsors / Collaborators

    Lead Sponsor: Loyola University
    Responsible Party: N/A

    Location

    Maywood, Illinois, USA

    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.

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 59
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.

    Secondary Outcomes

    • Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.

    • Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.

    • Patient request for additional pain medications at 30 minutes post initiation of drug administration

    • Patient request for additional pain medications at 60 minutes

    • Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.

    More Details

    NCT Number: NCT03714620
    Other IDs: 211328
    Study URL: https://clinicaltrials.gov/study/NCT03714620
    Last updated: Sep 29, 2023