Oral Ketamine for Control of Chronic Pain in Children
CompletedPhase 1NCT01369680
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Oral Ketamine for Control of Chronic Pain in Children
- Conditions
- Interventions
- Sponsor
- University of Rochester
- Start date
- 2011-05
- Primary completion
- 2012-10
- Sex
- All
- Age range
- from 8 Years to 22 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01369680