Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT01755169
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
20 Years
Study:
NCT01755169
Study Brief:
Protocol Section:
NCT01755169