Ketamine in Chronic Kid's PainKiCK Pain
This study is currently recruiting participants.
Verified January 2013 by Medical University of South Carolina
Sponsor:
Medical University of South Carolina
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 28, 2013
Last verified: January 2013
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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 2014 |
| Estimated Primary Completion Date: | January 2014 (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
|
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
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 28, 2013 |
| 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:
|
Ketamine Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013