Ketamine in Chronic Kid's (KiCK) Pain

Phase 2

Terminated

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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ketamine 0.25 mg/kg/dose	Ketamine	A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine 0.5 mg/kg/dose	Ketamine	A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine 1 mg/kg/dose	Ketamine	A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicity	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.

Secondary Outcome Measures