Ketamine in Chronic Kid's (KiCK) Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ketamine in Chronic Kid's (KiCK) Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine 0.25 mg/kg/dose<br>A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks. | Drug: Ketamine<br>* Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).<br>* Other names: Ketalar;|
| Experimental: Ketamine 0.5 mg/kg/dose<br>A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks. | Drug: Ketamine<br>* Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).<br>* Other names: Ketalar;|
| Experimental: Ketamine 1 mg/kg/dose<br>A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks. | Drug: Ketamine<br>* Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).<br>* Other names: Ketalar;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Child, Pediatric, Ketamine