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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Pain
Interventions Drug: Ketamine
Drug: Placebo
Enrollment 7
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo
Hide Arm/Group Description

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

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

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

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

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

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

Placebo
Period Title: Overall Study
Started 2 1 0 1
Completed 2 1 0 1
Not Completed 0 0 0 0
Arm/Group Title Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo Total
Hide Arm/Group Description

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

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

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

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

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

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

Placebo Total of all reporting groups
Overall Number of Baseline Participants 2 1 0 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
8-20 years Number Analyzed 2 participants 1 participants 0 participants 1 participants 4 participants
2
 100.0%
1
 100.0%
0
1
 100.0%
4
 100.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 0 participants 1 participants 4 participants
Female
2
 100.0%
0
   0.0%
0
0
   0.0%
2
  50.0%
Male
0
   0.0%
1
 100.0%
0
1
 100.0%
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 0 participants 1 participants 4 participants
2 1 1 4
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo
Hide Arm/Group Description:

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

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

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

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

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

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

Placebo
Overall Number of Participants Analyzed 2 1 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo
Hide Arm/Group Description

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

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

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

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

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

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

Placebo
All-Cause Mortality
Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%)   0/0   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine 0.25 mg/kg/Dose Ketamine 0.5 mg/kg/Dose Ketamine 1 mg/kg/Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%)   0/0   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amy-Lee Bredlau
Organization: MUSC
Phone: 843-876-0444
EMail: bredlau@musc.edu
Layout table for additonal information
Responsible Party: Amy-Lee Bredlau, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01755169    
Other Study ID Numbers: KiCK Pain
First Submitted: December 18, 2012
First Posted: December 24, 2012
Results First Submitted: November 28, 2016
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017