Chronic Pain | Ketamine in Chronic Kid's (KiCK) Pain
Chronic Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:KetamineParticipants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Ketamine 0.25 mg/kg/doseA 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine 0.5 mg/kg/doseA 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine 1 mg/kg/doseA 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Start Date: January 2013
Completed Date: May 2015
Phase: Phase 2
Primary Outcome: Number of Participants With Dose Limiting Toxicity
Study sponsors, principal investigator, and references
Principal Investigator: Amy-Lee Bredlau, MD
Lead Sponsor: Medical University of South Carolina