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

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 2

Conditions: Chronic Pain

Treatments: Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01755169

KiCK Pain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 8 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

7 participants in 4 patient groups, including a placebo group

Ketamine 0.25 mg/kg/dose

Experimental group

Description:

A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

Treatment:

Drug: Ketamine

Ketamine 0.5 mg/kg/dose

Experimental group

Description:

A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

Treatment:

Drug: Ketamine

Ketamine 1 mg/kg/dose

Experimental group

Description:

A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo