Ketamine in Chronic Kid's (KiCK) Pain
Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: Ketamine (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Medical University of South Carolina Official(s) and/or principal investigator(s):
Amy-Lee Bredlau, MD, Principal Investigator, Affiliation: Medical University of South Carolina
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.
Clinical Details
Official title: Ketamine in Chronic Kid's (KiCK) Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Dosage of ketamine that is most tolerable
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.
Eligibility
Minimum age: 8 Years.
Maximum age: 20 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Starting date: January 2013
Last updated: May 21, 2015
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