Ketamine in Chronic Kid's (KiCK) Pain

Chronic Pain Clinical Trial

— KiCK Pain  

Official title:

Ketamine in Chronic Kid's (KiCK) Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01755169
• Other study ID #: KiCK Pain
• Status: Terminated
• Phase: Phase 2
• First received: December 18, 2012
• Last updated: October 4, 2016
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 20 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Ketamine
Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of ketamine that is most tolerable	The dosage that is best tolerated by participants will be selected as the dosage to be studied in future trials.	2 weeks	Yes