Ketamine in Chronic Kid’s (KiCK) Pain

Overview

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.

Full Title of Study: “Ketamine in Chronic Kid’s (KiCK) Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2015

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Ketamine 0.25 mg/kg/dose
    • A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
  • Experimental: Ketamine 0.5 mg/kg/dose
    • A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
  • Experimental: Ketamine 1 mg/kg/dose
    • A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Dose Limiting Toxicity
    • Time Frame: 2 weeks
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amy-Lee Bredlau, Director, Pediatric Brain Tumor Program – Medical University of South Carolina
  • Overall Official(s)
    • Amy-Lee Bredlau, MD, Principal Investigator, Medical University of South Carolina

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