Ketamine in Chronic Kid's PainKiCK Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Amy-Lee Bredlau, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01755169
First received: December 18, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Chronic Pain
Drug: Ketamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine in Chronic Kid's Pain (KiCK Pain)

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Dosage of ketamine that is most tolerable [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    The dosage that is best tolerated by participants will be selected as the dosage to be studied in future trials.


Estimated Enrollment: 52
Study Start Date: January 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo arm. A 5mL liquid placebo will be given three times daily for 2 weeks.
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 20 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755169

Contacts
Contact: Amy-Lee Bredlau, MD 843-876-2872 bredlau@musc.edu
Contact: Patricia Infinger, CCRP (843) 792-7857 infingep@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amy-Lee Bredlau, MD    843-876-2872    bredlau@musc.edu   
Principal Investigator: Amy-Lee Bredlau, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Amy-Lee Bredlau, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Amy-Lee Bredlau, Director, Pediatric Brain Tumor Program, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01755169     History of Changes
Other Study ID Numbers: KiCK Pain
Study First Received: December 18, 2012
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Chronic pain
Child
Pediatric
Ketamine

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 18, 2014