Ketamine in Chronic Kid's (KiCK) Pain

Ketamine

Brief Summary

This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study.

Intervention / Treatment

  • Ketamine (DRUG)
    Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
  • Placebo (DRUG)
    N/A

Condition or Disease

  • Chronic Pain

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 8 Years to 20 Years
    Enrollment: 7 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Jan 01, 2013
    Primary Completion: May 01, 2015 ACTUAL
    Completion Date: May 01, 2015 ACTUAL
    Study First Posted: Dec 24, 2012 ESTIMATED
    Results First Posted: Jan 23, 2017 ESTIMATED
    Last Updated: Nov 28, 2016

    Sponsors / Collaborators

    Lead Sponsor: Medical University of South Carolina
    Responsible Party: N/A

    Location

    Charleston, South Carolina, USA

    Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.

    Participant Groups

    • A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

    • A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

    • A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 8
    Maximum Age: 20
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Subject, parent, or guardian willing and able to give informed consent
    * NRS for pain over the past 24 hours \>4 at baseline
    * Chronic pain, which has been present for \>3 months, or persisting longer than is normal for the underlying diagnosis
    * Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)
    * Able to tolerate and cooperate with neurocognitive assessment
    * Age 8-20 years old

    Exclusion Criteria:

    * If they are known or suspected to have drug addiction
    * Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder
    * Uncontrolled hypertension
    * Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.
    * Previous intolerance or allergic reaction to ketamine
    * Pregnancy
    * Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.
    * Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.

    Primary Outcomes

    • A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.

    More Details

    NCT Number: NCT01755169
    Acronym: KiCK Pain
    Other IDs: KiCK Pain
    Study URL: https://clinicaltrials.gov/study/NCT01755169
    Last updated: Sep 29, 2023