Phase 1
N=12
Oral Ketamine for Control of Chronic Pain in Children
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01369680 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Feb 2013
Primary outcome: Primary: Number of Participants Tolerating Dose — 3; 3; 3; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ketamine (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Tolerating Dose |
3; 3; 3; 1 | — |
| SECONDARY Neurocognitive Effect |
0; 0; 0; 0 | — |
| SECONDARY Norketamine Cmax (Measured in ng/mL). |
37.5; 135; 250 | — |
| SECONDARY Pain Control |
3; 0; 2; 0 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT01369680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.