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Ketamine in Chronic Kid's (KiCK) Pain

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: Ketamine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Amy-Lee Bredlau, MD, Principal Investigator, Affiliation: Medical University of South Carolina


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.

Clinical Details

Official title: Ketamine in Chronic Kid's (KiCK) Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Dosage of ketamine that is most tolerable

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.


Minimum age: 8 Years. Maximum age: 20 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information

Starting date: January 2013
Last updated: May 21, 2015

Page last updated: August 23, 2015

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