Ketamine in Chronic Kid's PainKiCK Pain

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.

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.