Oral Ketamine for Control of Chronic Pain in Children
Completed · Phase 1
Conditions studied: Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT01369680
- Run by
- University of Rochester
- People needed
- 12
- Starts
- 2011-05-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2013-02-15
Who can join
Age: 8 and older, up to 22. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.