Oral Ketamine for Control of Chronic Pain in Children

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a maximum tolerated dose finding study for oral, chronic, daily administration of oral ketamine (by mouth) in children with long-term daily pain.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Subject, parent, or guardian willing and able to give informed consent

• NRS for pain >4

• Chronic pain, which has been present for >3 months, or persisting longer than is normal for the underlying diagnosis

• Chronic pain related to 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 8-22 years old

Exclusion Criteria:

• If they are known or suspected to have drug dependence or addiction

• History of psychiatric disorder such as depression, schizophrenia, or bipolar disorder

• History of hypertension

• Unable to cooperate with neurocognitive assessment

• Chronic pain related to chronic abdominal pain syndrome

• 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.