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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Placebo; Drug: Ketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Amy-Lee Bredlau, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Child; Chronic pain; Pediatric; Ketamine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: KiCK Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be shared.