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

Chronic Pain

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source