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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755169
Recruitment Status : Terminated (Inability to enroll sufficient patients)
First Posted : December 24, 2012
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Amy-Lee Bredlau, Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Ketamine Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine in Chronic Kid's (KiCK) Pain
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Ketalar
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicity [ Time Frame: 2 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755169


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Amy-Lee Bredlau, MD Medical University of South Carolina
More Information
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Responsible Party: Amy-Lee Bredlau, Director, Pediatric Brain Tumor Program, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01755169    
Other Study ID Numbers: KiCK Pain
First Posted: December 24, 2012    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregate data will be shared.
Keywords provided by Amy-Lee Bredlau, Medical University of South Carolina:
Chronic pain
Child
Pediatric
Ketamine
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action