Chronic Pain
Conditions
Keywords
Chronic pain, Child, Pediatric, Ketamine
Brief summary
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.
Detailed description
Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.
Interventions
DRUGKetamine
Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
DRUGPlacebo
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity | 2 weeks | A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4. |
Countries
United States
Participant flow
Pre-assignment details
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
Participants by arm
| Arm | Count |
|---|---|
| Ketamine 0.25 mg/kg/Dose A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant). | 2 |
| Ketamine 0.5 mg/kg/Dose A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant). | 1 |
| Ketamine 1 mg/kg/Dose A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant). | 0 |
| Placebo Placebo | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Ketamine 0.25 mg/kg/Dose | Ketamine 0.5 mg/kg/Dose | Ketamine 1 mg/kg/Dose | Placebo | Total |
|---|---|---|---|---|---|
| Age, Customized 8-20 years | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Gender Female | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Gender Male | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | — | 1 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 0 | 0 / 1 |
Outcome results
Primary
Number of Participants With Dose Limiting Toxicity
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine 0.25 mg/kg/Dose | Number of Participants With Dose Limiting Toxicity | 0 Participants |
| Ketamine 0.5 mg/kg/Dose | Number of Participants With Dose Limiting Toxicity | 0 Participants |
| Ketamine 1 mg/kg/Dose | Number of Participants With Dose Limiting Toxicity | 0 Participants |
| Placebo | Number of Participants With Dose Limiting Toxicity | 0 Participants |