Ketamine in Chronic Kid's (KiCK) Pain
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT01755169
- Run by
- Medical University of South Carolina
- People needed
- 7
- Starts
- 2013-01-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2017-01-23
Who can join
Age: 8 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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