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

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Child, Pediatric, Ketamine

Eligibility Criteria

8 Years - 20 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Ketamine 0.25 mg/kg/dose

Ketamine 0.5 mg/kg/dose

Ketamine 1 mg/kg/dose

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2012
Last Updated
November 28, 2016
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01755169
Brief Title
Ketamine in Chronic Kid's (KiCK) Pain
Acronym
KiCK Pain
Official Title
Ketamine in Chronic Kid's (KiCK) Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Inability to enroll sufficient patients
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Child, Pediatric, Ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine 0.25 mg/kg/dose
Arm Type
Experimental
Arm Description
A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Arm Title
Ketamine 0.5 mg/kg/dose
Arm Type
Experimental
Arm Description
A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Arm Title
Ketamine 1 mg/kg/dose
Arm Type
Experimental
Arm Description
A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy-Lee Bredlau, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only aggregate data will be shared.

Learn more about this trial

Ketamine in Chronic Kid's (KiCK) Pain

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