Overview

Ketamine in Chronic Kid's (KiCK) Pain

Status:
Terminated
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of South Carolina
Treatments:
Ketamine
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.