CompletedPhase 1ketamine
Oral Ketamine for Control of Chronic Pain in Children
Sponsored by University of Rochester
NCT ID
NCT01369680
Target Enrollment
12 participants
Start Date
2011-05
Est. Completion
2012-10
About This Study
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.
Conditions Studied
Interventions
- •Ketamine
Eligibility
Age:8 Years - 22 Years
Healthy Volunteers:No
View full eligibility 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.
Study Locations (1)
University of Rochester
Rochester, New York, United States